22 Burst results for "Cell Culture Dish"

"cell culture dish" Discussed on Cell Culture Dish Podcast

Cell Culture Dish Podcast

02:36 min | 3 months ago

"cell culture dish" Discussed on Cell Culture Dish Podcast

"Now, I'd like to ask something. That's really important to our listeners and that is. If you could describe what the implementation of the nuclear counter looks like for scientists interested in incorporating this into their workflow. So the nuclear counter is very easy to use is particularly important if you want to standardize a process. This is both the case of your research. That wants to share protocols with colleagues, but also in manufacturing setups that you want to scale. So the cassette replaces three workflow steps that you have other still counting methods, which is the edition of die the loading of the cells into accounting, chamber and the focusing before you can actually perform the so count. So in summary The simplicity of the operation will make it much easier to implement in any process, because the standard operation procedures will be shorter and it's easier to train new people to use the instrument. Another important advantage of the institute hundred is that can easily be deployed in clean rooms. It is easy to clean and it doesn't require any maintenance. Regula validation is enough to ensure consistent performance of the instrument. I JUST WANNA. Thank you so much for your time today. This was really interesting and I think it's a very important topic. Think cell counting as you mentioned. Standardization of salt counting in particular is really important in terms of reproducibility, and ensuring that our research is valid and so I. Really Want to thank you for for coming and speaking today. Do you have anything else that you would like to add for? Our listeners before we sign off. Cuba medic is still operational, so if you feel like trying out the new of please give us a call. Normally we would always send our field applications scientists to get people started with a nuclear counter. But because of these unusual times we've made a video results where people can go ahead and set up the instrument and get started without any help from feel application scientist. Will ship the instrument, and typically a week is enough to test the performance of the nuclear counter with yourself systems. Thank you again. Thank you for joining us for this edition of the cell culture dish podcast to learn more about this and other stem cell bio manufacturing related topics. Please visit us at www dot, cell, culture, dot, com, or for downstream bio. Manufacturing topics www dot downstream column dot com..

Cuba scientist
"cell culture dish" Discussed on Cell Culture Dish Podcast

Cell Culture Dish Podcast

04:30 min | 3 months ago

"cell culture dish" Discussed on Cell Culture Dish Podcast

"Ensure reproducibility and experiments assays in manufacturing processes, I'm Brandy Sergeant at her cell culture dish joining me today is Christian Burke Global Product manager at Chemo medic. Mr Berg is a biochemist from the University of Copenhagen and work with neuronal stem cell research before transitioning to the software industry to develop learning products for McGraw Hill Higher Education. After relocating to the United, States Christian joined Chemo medic in two thousand, fourteen to advise leading companies on the implementation of cell counting in regulated environments as Global Product Manager for the nuclear counter products Christian is currently responsible for developing tools for customers in antibody, virus and cell therapy development, and to implement cell counting that is both highly robust and scalable this year Christian and the Chemo Medic team released the nuclear counter NC two A. Two which aims to standardize cell counting across the industry and accommodate the needs for manufactured automation. I'd like to start today by discussing the importance of cell counting. Could you tell listeners a little bit about why cell counting is so important? So we talk about so counting in context of the application there the different disciplines that used million cells and in some disciplines. It's obvious that still counting is important for example when you use sells for manufacturing pharmaceuticals, you also use so counting when use the sells for for bio essays, not only in Pharma, it could be that you use the bio essays for toxicology testing, but informally also use it for quality testing of. Products I actually look at the activity of the final product, and he'll use the cells to report the activity of the drug, and when you set up, such processes you also want them to be a standardized family. You also seen the emergence of self. Therapy's south therapies have completely new processes a new requirements for cell counting..

Chemo medic Global Product Manager Chemo Medic Brandy Sergeant Christian Mr Berg McGraw Hill Higher Education University of Copenhagen NC
"cell culture dish" Discussed on Cell Culture Dish Podcast

Cell Culture Dish Podcast

08:05 min | 3 months ago

"cell culture dish" Discussed on Cell Culture Dish Podcast

"Companies meet the challenges of twenty-first-century bio manufacturing. I'm Brady Sergeant. Cell Culture dish joining me today is Marcus Crusader chief scientific officer at synthase. Marcus co-founded synthase after working as a research associate in synthetic biology at University College London where he developed novel Bio Synthesis Methods using pathway engineering prior to ucla, he was a bio transformation scientists working as part of an industrial biotechnology group that conducted more than ninety contract research projects for over twenty clients. Marcus has a PhD in plant biochemistry from Durham. I'd like to start by asking if you could tell us a bit about the concept of bioprocessing four point zero, and what it means to the industry. By purchasing full. Has Come from a cut derived from the attempts of industry full point. And will that's referring to. Is the Barracks Industrial Revolution which happen which is made human production Gamal as sophisticated, inefficient through the ages first industrial revolution, we just quoting a Siamese what steams to be used as a power source, replacing manual effort, the chemical energy. Dramatic increases the productivity as possible. Within Industry and then moving onto electrification, innovation production lines any more efficient ways of producing products an visit us. Industrialization around Automation Electronic Control that. So they find the content industry full point. As is often referred to in thinking. Okay. How can we connect all of the different devices of pieces of information that we might have particular setting? Connect those in to to the digital. Computing where you can have data storage across crossing and data analysis, so then debates this. Use of automated production is that one level higher allows the three sophisticated knowledge in control of what's going on, we take. This is particularly important for area such as processing. Biological Because of the complexity of what we daily with, so we really need to be able to get to grips with the complexity of the processes. Running on wore the day to this coming out with those and get into Rica era format such we can use asked me as we progress. That's really interesting. You explain. The Solutions synthase provides in this area. said they didn't start out as companies as we all now, so these days we provide software ted help people do their science recently made this offering the first late is because we processing. Those looking for ways of doing more sophisticated automated experiments in order to address the next is the will to do so the cool capability software. Anthony is the older generation. ultimated instructions abolish Christ calls. While is means is the scientists can rapidly specify They want to run. The works out all the details down to the every step of run protocal it can convert those detailed actions. The scripts that needed particular. These Commission and Toronto away from the intent. The scientist is given the software old way through old details that needed to actually run at intended experiment. Includes will to calculating the volumes concentrations, the reagents in the samples that needed shows the US to set those regions on on your. So then using that. Hey, go on the road. Will that wrong this? Project Hope with instructions. To generate. Amidst. Substantially more usable impactful at the moment there's a real issue It's highly flexible due to the complexities of programming and so out, there allows much more flexible, useful information. Law Context for more complex experimentation. So. Now's where we started. To do some really cool experiments that we re proud, generated number case studies which show the power of using automation in all science. But. It also has a really big beneficial effect when it comes to digital integration. If we think about all the different devices we have within the lab. Is the automation is? Also Dr and actually we have about electrical devices in particular, which is an associated with those. Two nations which actually produced the data, which is the whole point running experience in the first place. What we need is a way of structuring dates from all of these diverse diversities equipment. Now because generated all the petting steps that go on in particular protocol, it means that it has that detailed structure of the experiments, so at the end of any chain of petting actions is often this Alex cool device that produces some data. Out The has that chain of providence everyday to point this reduced experiment? As what it means is, it can trace back full provence oath. Where they come from, and hence if you can do that for all the day, tickets structure data in the context of the experiment to design. We found this to be a real issue against as we are running more complex and and high throughput experiments than actually the ball. Nate moved into data structuring. What we find is that by using a more automated method overruling alive? It gives us this opportunity for auto data structuring as well so. It's become this tool which allows the automation of processes, but then also the automation of the data processing the goes on from those not purchases in Alaska integrate very dynamic flexible way because it's updating Thursday destruction structures of the experiments. Think, it's really great that you started as bioprocessing company because you understand exactly what scientists in this area would need and can structure of tools that would be specifically designed to help in the scientific area. Could you tell us a little bit more about the technology behind the product? It does give us an insight the maybe otherwise we wouldn't have. Necessarily recommended as a cost to go down as a company of fundamentally restructuring yourself from the entirely different business model to ask you inside. One of those things allows us to do is take that step back and think about okay if we need if we want to new way your programming. That doesn't rely on hunting every every detail out yourself programming every single repenting. Step yourself in lorries not. What information would potential piece of software need in order to be able to also calculate all of those details itself so this constant back in those? At meteorologists software engineers that we it out. What are the different bits of information requests? Diversities. You need some specifying a particular protocol right so if we think about some of state protocol sometimes steps in it. Either nations might then have in attending replicas, Maine's. Than what we can do, an atmosphere as we can, basically taking something which specifies the samples in east Specifies that we want to die. off the dot net wreck off. We build that framework a of a specific parts cult, but then you actually need to put some specifics around in this case. How many donations do we want to do both the? Factories says on volume to the Dietitian while kind of Zoe diluting, and then when we go onto, the replication might volume.

scientist Marcus Crusader Brady Sergeant Automation Electronic Control Durham US ucla chief scientific officer Cell Culture Barracks Industrial Revolution research associate University College London Toronto Anthony Gamal
Computer Aided Biology Platform Helps Companies Meet the Challenges of 21st Century Biomanufacturing

Cell Culture Dish Podcast

04:40 min | 3 months ago

Computer Aided Biology Platform Helps Companies Meet the Challenges of 21st Century Biomanufacturing

"Marcus co-founded synthase after working as a research associate in synthetic biology at University College London where he developed novel Bio Synthesis Methods using pathway engineering prior to ucla, he was a bio transformation scientists working as part of an industrial biotechnology group that conducted more than ninety contract research projects for over twenty clients. Marcus has a PhD in plant biochemistry from Durham. I'd like to start by asking if you could tell us a bit about the concept of bioprocessing four point zero, and what it means to the industry. By purchasing full. Has Come from a cut derived from the attempts of industry full point. And will that's referring to. Is the Barracks Industrial Revolution which happen which is made human production Gamal as sophisticated, inefficient through the ages first industrial revolution, we just quoting a Siamese what steams to be used as a power source, replacing manual effort, the chemical energy. Dramatic increases the productivity as possible. Within Industry and then moving onto electrification, innovation production lines any more efficient ways of producing products an visit us. Industrialization around Automation Electronic Control that. So they find the content industry full point. As is often referred to in thinking. Okay. How can we connect all of the different devices of pieces of information that we might have particular setting? Connect those in to to the digital. Computing where you can have data storage across crossing and data analysis, so then debates this. Use of automated production is that one level higher allows the three sophisticated knowledge in control of what's going on, we take. This is particularly important for area such as processing. Biological Because of the complexity of what we daily with, so we really need to be able to get to grips with the complexity of the processes. Running on wore the day to this coming out with those and get into Rica era format such we can use asked me as we progress. That's really interesting. You explain. The Solutions synthase provides in this area. said they didn't start out as companies as we all now, so these days we provide software ted help people do their science recently made this offering the first late is because we processing. Those looking for ways of doing more sophisticated automated experiments in order to address the next is the will to do so the cool capability software. Anthony is the older generation. ultimated instructions abolish Christ calls. While is means is the scientists can rapidly specify They want to run. The works out all the details down to the every step of run protocal it can convert those detailed actions. The scripts that needed particular. These Commission and Toronto away from the intent. The scientist is given the software old way through old details that needed to actually run at intended experiment. Includes will to calculating the volumes concentrations, the reagents in the samples that needed shows the US to set those regions on on your. So then using that. Hey, go on the road. Will that wrong this? Project Hope with instructions. To generate. Amidst. Substantially more usable impactful at the moment there's a real issue It's highly flexible due to the complexities of programming and so out, there allows much more flexible, useful information. Law Context for more complex experimentation. So. Now's where we started. To do some really cool experiments that we re proud, generated number case studies which show the power of using automation in all science. But. It also has a really big beneficial effect when it comes to digital integration. If we think about all the different devices we have within the lab. Is the automation is? Also Dr and actually we have about electrical devices in particular, which is an associated with those. Two nations which actually produced the data, which is the whole point running experience in the first place. What we need is a way of structuring dates from all of these diverse diversities equipment.

Scientist Marcus Automation Electronic Control Barracks Industrial Revolution Durham Ucla United States Research Associate University College London Gamal Toronto Commission Anthony
"cell culture dish" Discussed on Cell Culture Dish Podcast

Cell Culture Dish Podcast

08:20 min | 4 months ago

"cell culture dish" Discussed on Cell Culture Dish Podcast

"Tested Relevant posted the Alex unmanufactured technology platform that allows us to establish high-performance processes In that equation Costume Manufacture Ability Onondaga. In fact able to incorporate a manufacturer ability assessments into that equation the the more likely of having a great success as regards to the cost of the manufacturing process and one thing that we realized particularly as it relates to buy Steve Antibodies. And this is something that Seven alluded to earlier. Is that the level of diligence us? Up Front in the design and potent engineering of the by State Round Body pays dividends later in the form of high With minimum production liabilities out over to caveat to add to that thanks. I mean so. I think in terms of cost and manufacture ability really. What it comes down to is You need by producing selling and you need as much Offer Simpler Process For purification as possible and not have unusual Raw materials needed to achieve the purity. And we not about by specifics. Actually we see very high tighter. We have seen up to ten grams per liter and From the get go. Fifty high purity of Hetero Dahmer's which Which is very encouraging. It does depend on the format of the molecule as as well so I feel that in order to become a fully proficient in terms of making specifics I considering the platform the format is important as well as as early as possible to manufacture ability assessment and look at the overall cost from early on and not just the activity up the molecule. I really liked to ask this next question of experts on industry issues and I'm hoping that both selects is an. Kpi can respond if you could look into your crystal ball. Where do you see by specifics? In the next five years sure Very happy to take care. Take it on behalf of Alexis. I certainly have my crystal ball in front of me right now and I can tell you that we are definitely seen a growth in the by specific. Antibodies as therapeutic modality to treat previously onto the disease such as concept and even infectious diseases and other types of diseases actually more recently at the American Society for Mythology Conference. It was an eye opener to discuss with products. As it showcase several early clinical success. Stories in oncology especially when compared against other therapeutic modalities such as the TS actually caught. He's have of recent with the recent approvals of few copies for treatment of MTA. Logical Council have been seen as the innovative therapeutic modalities to treat these types of diseases yet are still a lot of challenges that. I believe by specifics that antibodies actually have the opportunity to compete neck and neck against and displaced tease as the preferred modality. I one of those reasons is because by specific. Antibodies can be off the shelf. Therapies vessels Teased that after be customized to each individual patient additionally. There's a cost advantage to relied on the antibodies. Therapeutic modality for treatment Ovalles of different diseases vessels tease since counties again have to be customized to the individual patients and I the most recent costs to the patients that we've seen could run into be high hundreds of thousands of dollars for treatment of patients but for by specifics artistically to be a lot more reasonable all in all this will translate into much better patient benefits and as a result of that. I think that we would anticipate seen by specific Sabina mainstay for treatment of some of these more complex disease of high unmet need. Kpi may be they have They can put onto sure. We definitely expect the trend of moving from map to buy specific to continue and portfolios to become more and more heavy on by specifics. In fact over the next five years would expect By specifics and multi specifics and multi of maps to become more more fifth primary Sort of a component of our portfolio and we expect as clinical data are through a more of a convergence in terms of the format off. The bye specifics. That are best suited for efficacy as well as for for manufacture ability to become more of us So that by specifics. Mother specifics become as garden variety. As Matt's time I WanNa thank you all again for joining us on the panel today. I think it was a really interesting. Conversation was really helpful to learn more about by specifics including the challenges but also the solutions that are available and I really just appreciate everyone's time today. I'd like to close by asking each of the panel members. If there's anything that they would like to add for our audience before we end the podcast yet maybe I'll just like to reiterate that we have today twelve in over thirty different by special antibody programs between select Sankei. Bi with various designs different complexities. Some of which are even more complex. An office Majority of these have been transferred to KPI for development and manufacturing one found out. Is that Way To see good predictability varian by leveraging our model of workflows all the way from line development process development. Scale up on manufactuer. And I think we don't have dimension previously but I like to reiterate again we really see excellent productivity ranges that are comparable to standard antibodies in the range of two to five player in shake flask with the over ninety. Five percents Dama purity I production scale so this is actually pretty good. I think and I'd say it's a point. I like to really emphasize to the experience and expertise that we have a lettuce on. Kpi thanks Yummy. A from the perspective. Sigmon I have booked this or number of years and I think we're quite proud of this offering it's It's you know having the the foundation of this. Alexis Technology is a lot of fun for our development scientists because they know there's potential to really improve tigers and and have a very high cherish purification and and the scale ability to manufacturing It's just something that's gone very well for for us Because we've done this intensely the last three years and it's a real point of focus for us that that has enabled housing rates and that gives us a lot of confidence For programs coming in the door there's other offerings out there but we think we're more experienced in this offering and we look forward to Helping bring more partners to I N D in person human and then from there Look forward to doing late phase development and commercialization down the road. Thank you so much again for your perspectives. Today I really look forward to following by specifics and where the technology goes from here. Thank you thank you. Thank you for joining us for this edition of the cell culture dish podcast to learn more about this and other stem cell and bio manufacturing related topics. Please visit us at. Www DOT cell culture dish dot com or for downstream bio manufacturing topics www dot downstream column dot.

Costume Manufacture Ability On Alex unmanufactured technology Seven Alexis Technology Hetero Dahmer American Society for Mythology Alexis MTA Logical Council Sabina Ovalles Sankei Matt
"cell culture dish" Discussed on Cell Culture Dish Podcast

Cell Culture Dish Podcast

09:45 min | 4 months ago

"cell culture dish" Discussed on Cell Culture Dish Podcast

"To the cell culture dish podcast by specific antibodies the development manufacturer and promise these cutting edge therapeutics. I'm brandy such an editor of the cell culture dish in this podcast. We conducted a panel discussion with experts from Alexis and KPI Bio Pharma on by specific antibodies. We examined by specific antibody development and manufacturing including current challenges in key solutions. We also discussed the promise of these. Cutting Edge Therapeutics and their future in medicine. I'm very excited to have this panel with us today to speak on this topic which I think is really important. I'm going to let each of the panel members introduce themselves before we get started Burundi. My name is Jimmy on a clay. I'm the chief business officer at Alexis my name as assuming Tiempo Director of selling services at selects his Geneva. Hi this is Simone Moustapha Stefan Vice President for process development at KPI North Carolina. Hello this is stuart McConnell. I'm senior vice. President of business development it be based on North Carolina. Thank you all for speaking to my audience today. I find this topic so interesting as I really see novel. Non Natural Protein Therapeutics is being the next and medicine by specifics in particular have demonstrated tremendous promise and like many other new modalities also challenges today. I'm excited to talk to all of you about the current challenges in by specific manufacturing and more importantly the solutions that you have developed. I'd like to start by talking about cell line development. We all know that show cells have been a very successful workhorse. In the manufacturer of recombinant protein therapeutics and that show cell lines have been optimized over many years to provide the best productivity and product quality. However as is they're not up to for new protein therapeutics like by specifics. Could you please share with listeners? Some of the key challenges with Chou Cell Lines and by specific production absolutely firstly. I'd like to clarify misnomers Production for recumbent proteins in saline Since these actually require sufficient cooperation of DNA encoding the protein into dealer productive. National of the cells most frequently chromosomes in the new Matrix in a manner that allows for efficient transcription translation on secretion from the cell. Now this is not trivial especially considering that foreign DNA have propensity to be shut down as a result of different regulatory mechanisms. Furthermore own into the nature of the protein translation as secretion machinery of the wholesale may not be adequately suited to rotate. We've got said like severing to talk. Specifically of the challenges for by specifics brings a line development into the picture y producing bi specific. Antibody is more difficult than classic or maps. It's all about complexity of the format. The first challenge is at by specific. Antibodies should decreased productivity as compared to classical maps bi specific antibody formats wizard from protein engineering. Then can be close to anybody shape or not with the should not domains or additional inkers by definition Zaza focused itchy different complex. Poly Peptide chains that has to be associated to lead to the final format in one sees petty. Change show a different expression level on the other hand to force spurring is sometimes insufficient and lead to the production of by side product. It reduced the productivity of expected format. The second challenge is a satellite development process itself. It has to be redesigned. In order to meet the unique characteristics of bi specific antibody we have to ensure the portion of the right molecules rather than the best producing one so productivity and adapted process up to my mind's main challenges of by specific antibodies. Thank you for clarifying. Bi specific antibody production and the challenges associated with it. I know that the team at Alexis is developed a series of modules for your technology platform that address the challenges you mentioned. Can you explain how the modules work yes sure in fact we have many modules in the platform? But I'm GonNa talk about only the threes related to by specific antibodies. So I we have a flexible molecule design second. We have a reliable hostile line. And so optimize said nine development platform so as I. Alexis can modulate expression at the molecule que. How strategy is to individually clone each peptide chain constituting a bi specific antibody into an independent poke containing selects genetic elimi-. Imagine that you have changed. That is politics expressing by using our approach we can increase the ratio amount of this problematic chains. As compared to the other one consequently adds a toss fiction stage we would be able to restore a good assembly of the final by specific molecule format. And imagine that we still need to increase the expression level. We can inject the Into the genomic. Dna which goes super collection in order to boost the expression. The second tool is a copious Saline by using a single cell line we will directly produce by specific antibody in its final. Assemble formats again. If a bi specific is very hard to express we will provide the solution by using our libraries. These are panel of Genetically Modified That could express helper. Putin set could APP to rescue a by specific program by targeting specific expression. Best way at the origin of the expression last out process is completely adapted to buy specific antibody. We have the capacity to evaluate the quality of by specific as soon as early stages of saline development we have introduced early checkpoints for purity valuation for example we use high throughput screening at the micro scale k. To monitor the percentage off. It'll diamonds this enable us to directly easily. The right currents thank you for that. That was really interesting. I had one follow up. Question on the cell line development side. Establishing clarity is an important part of cell line development. Can you talk a bit about how you achieve this at selects? Yes what's Alexis? We can demonstrate the regular who sororities that you. Sellin is originated from a single. Could you need excel at different stages of selling development fest and most obvious is at this stage of the easily of cons if we are using technology in which we easily late single lanese grown in semi-solid media we would provide statistics based on parameters such as Kuni shape off proximity from the other colonies? Usually two rounds are required to ensure monoclonal each. But now if we're using recently acquired technology based on the cheap one. Ron of sellers relation is sufficient as monoclonal would be based on imaging in this. Cloning technology to sales hallowed into the sheep and individually distributed in small pants live imaging with ensure said. You did put a single cell into each fan in addition to the process related Mona clarity. We are also capable to provide McConnell Assessment independently of the ongoing process. This is done by on sequencing. We are used to sequence searching Dna extracted from your cell and we demonstrate that the signature of the use was a gen was inserted is unique among scioto crowns by that. We Will Demonstrate Monaco unity based on sequencing. That explanation was really helpful. I want to switch lanes here and talk about the partnership between S- Alexis in Kpi Bio Pharma to delivered gene to jean-pierre nine months. I was really quite impressed by that. Can you discuss? How the partnership works and the competencies that each company contributes to that process. I can go first selects Firstly I just like to mention that Selassie Sankei be. I became affiliated a sister companies in June prentice. Seventeen pro position of Alexis by Jessica Corporation. Which is the parent company of KPI prior to the affiliation KPI process development GNP manufacturing over twelve different RCB's expressing different types of products including by specific antibodies and establish significant level of know-how and experience in. Welcome these satellites from Alexis. You may fuck interject be.

I. Alexis KPI Bio Pharma Cutting Edge Therapeutics Natural Protein Therapeutics Chou Cell Lines stuart McConnell Burundi North Carolina Simone Moustapha Stefan Vice P editor Jimmy chief business officer Geneva Tiempo Director President Selassie Sankei Zaza
"cell culture dish" Discussed on Cell Culture Dish Podcast

Cell Culture Dish Podcast

06:54 min | 4 months ago

"cell culture dish" Discussed on Cell Culture Dish Podcast

"Welcome

I. Alexis KPI Bio Pharma Cutting Edge Therapeutics Natural Protein Therapeutics Chou Cell Lines stuart McConnell Burundi North Carolina Simone Moustapha Stefan Vice P editor Jimmy chief business officer Geneva Tiempo Director President Selassie Sankei Zaza
Bi-Specific Antibodies  The development, manufacture and promise of these cutting-edge therapeutics

Cell Culture Dish Podcast

06:54 min | 4 months ago

Bi-Specific Antibodies The development, manufacture and promise of these cutting-edge therapeutics

"Welcome

Multistem A Stable

Cell Culture Dish Podcast

06:26 min | 4 months ago

Multistem A Stable

"Dr Van Dockland has served as chairman of the board of directors at Ather since August two thousand and as CEO since the company was formed overseeing the growth and development of the primary business operations of the company and the transition from a venture backed startup to nasdaq-listed Public Company. He also serves as chairman of the National Center for Regenerative Medicine. Doctor Van Lynn received his PhD genetics from Stanford University School of Medicine and earned degrees in both economics and molecular biology at the University of California at Berkeley. I'd like to start by asking. How regenerative medicine therapies are different than traditional pharmaceuticals and biologics? And what value can they bring questions? So regenerative medicine really consists of several different types of their include cell therapy gene therapy gene modified cell therapy and then tissue engineering approaches so those four different sectors. If you've will comprise collectively the the regenerative medicine space and regenerative general medicine is fundamentally different from traditional pharmaceuticals or approaches that have been used to develop biological their babies. Because typically those therapies are very specific entities or single agent therapies that hacked through a discrete well defined mechanism of action. Cells are different in. That sells can actually work through multiple different mechanisms of action so they're multidimensional in that regard. Gene therapy is different because gene therapy is not meant to provide a temporary fix or a specific problem or a specific. But it's meant to provide in some instances permanent you're or a long term cure by addressing the underlying defect that is affecting the patient in causing the condition or causing the disease so gene therapy and cell therapy or a little bit different from one another in terms of how they differ from pharmaceuticals and blogs but together they really represent a broad approach kind of a paradigm shift. If you will in terms of how people think about approaching the treatment The whole range of different diseases and conditions that are really not well served under current standards of care and that regard that really gets to the type of the value that can bring because you can imagine that in contrast the putting somebody on lifetime therapy of different types of medicines to help mitigate the damage specific disease or condition if you can actually offer up a specific intervention whether it be one or a series of administrations of cell therapy or gene modified cell therapy or gene therapy approach and affect long term durable improvement and even cure for many patients. That's a pretty exciting prospect and it also stated with a Bali now. It also creates some potential challenges. Because we're still trying to figure out. How do we establish a reimbursement? Framework for therapies. That might be single or a single administration. That could be cured. It have an impact over many many years. But there's actually been some pretty good progress on that front so both in terms of the way that these therapies work and also the impact they can have in some cases over very long timeframes. I think it's it's pretty exciting. I agree completely. I think it's really exciting. To think about cheers for diseases that have been managed or even untreatable up to this point and also What you mentioned about a new way to look at it is also really important. Because they're more expensive but you have the potential to cure or a therapy. That will last for a long period of time. And so it's exciting to think about these new therapies in along those lines. I was hoping you could share with listeners. In recent years what have been some of the most exciting clinical breakthroughs regarding regenerative medicine. Well it's actually pretty exciting in the sense that there's a growing number of things that either been validated through clinical development now approved by the FDA and other regulators on the cell therapy front. The Car T. therapies. Which are gene modified cell? Therapy approaches? Current therapies are actually tallahassee. You take cells derived from the patient themselves. You genetically modified those cells reintroduce into the patient to help fight the cancer that has in fact. By definition these are patients that have failed other forms of therapies other forms of intervention and the progress on that front has been incredibly exciting where we see several approaches. They've really had an impact. In terms of improving clinical outcomes in many cases for patients. They really had no other no other hope because they had exhausted all the available treatment options and then they were basically treated using these types of approach so those approaches are pretty exciting. I think bed some of the gene therapy there. Several gene therapy products that have been approved over the past several years whether it's Things from Bluebird or he'll chance Ma from onto partis or a vaccine which is the company that Nevada's acquired or looks turn up from spark therapeutics. All of these have shown very very exciting response levels among the patients that are being treated very very high levels of Progress Clinical progress or curative effects or demonstrable improvement in the primary clinical outcomes. And I think in many respects these just represent the tip of the iceberg. If you will in terms of things that are that are coming Recently actually just a few days ago out at the J. P. Morgan Conference in San Francisco the Alliance for Regenerative Medicine. And every year they do state of the industry overview and they present a lot of different data that really describes the phenomenal progress in terms of clinical development and companies advancing to the various phases of clinical development or seeing more more things in phase two and phase three and then also highlighting other things that are well-positioned or could be well positioned for approval. Within the next couple of years. I think all of the data that was presented this year really reinforces and underscores the fact that the regenerative medicine sector and community as a whole is making incredible progress that is attracting live investments a lot of partnerships and as making really good progress with respect to regulatory and clinical side of things. I mean we now have over a thousand programs that are in clinical development the regenerative medicine sector and I think that that really covers a lot of really exciting opportunities that that a lot of people have hope and optimism around in terms of how can change medicine as we know.

National Center For Regenerati Alliance For Regenerative Medi Chairman Stanford University School Of Dr Van Dockland Van Lynn Mechanism Of Action Nasdaq-Listed Public Company University Of California CEO Berkeley J. P. Morgan Conference FDA Tallahassee San Francisco MA Nevada
"cell culture dish" Discussed on Cell Culture Dish Podcast

Cell Culture Dish Podcast

05:36 min | 4 months ago

"cell culture dish" Discussed on Cell Culture Dish Podcast

"And so they are taking everything that has been learned in the biologic space and applying it to their own cell and gene therapy products that they're manufacturing clear just from talking to you How much time you spent thinking about what the user's experience would be and also what they they need from from this piece of equipment So it makes me curious. I'm wondering what the feedback has been like from your customers. Yes we've been very fortunate have had overwhelmingly positive responses so far it's been great to see systems being used intended soon after we left the installations. That's the key thing you train a group of people to run it while you're there and think that they know everything and are confident. Would you leave? But then they may not use system for weeks Luckily Bet has not been the case with the rebel. Not only are getting constant feedback and praises from the system. It's good Being the provider of the systems to see consumables being purchased in. That's a clear indication. That teams have rebels are utilizing it and are expanding their application space with it. Having said that it's not just been one-sided we are very proactive and reaching out to all of our users users have also been very responsive to our emails and checking calls. They love to share their internal success stories and they also love telling us that they're bragging colleagues in different parts of their organization about their early successes with the rebels. That's great to hear. Yeah it's wonderful when they share information across multiple groups and and share their their success story. So that's that must make really really happy. I wanted to ask you because this is something that always comes up with new technology Have there been any challenges associated with the implementation of the rebel to come to mind right off the bat. There's been a big push for Pharma. Four Point Oh and a lot of networking associated with that smart devices sharing data across organization seamlessly having said that there have been a lot of reluctance from department during installation and resisting network enabled devices into those laps. Buckley researchers and engineers have been a great ally here. They've been in full support to get rebels online in their labs because it's really critical for them to get access to their data as quickly as possible wherever they are. Another challenge has been at the rebel. Can output data to quickly. A lot of these groups are used to waiting on three days. Maybe five days or longer turnaround time from their Korla ibtx get spat media analysis information. And now they're getting that same data and minutes so it surprised groups when they load a trae samples overnight and they come in with a hundred data files from an entire process. So we've been working with them on streamlined data analysis strategies to keep up with their ever-growing numbers of sample sets and curiosities. That's great. That's a good problem to have to have data to quickly is better than to to not have it or to have it too slowly. I think something that definitely has to be dealt with but I think a good problem to have thank you so much for your time today. Been really interesting. I think this is a really interesting piece of technology and really useful and helpful with workflows in a and I was excited to learn about it But I'm I'm wanted to just end by giving you a chance to add anything else for our listeners that we may have missed during our talk today. Yes so I take your collaborations key both public and private one in particular that we have. It's with Sir at Clemson University. They've been spectacular to work with for a couple years now we actually just published her first of hopefully many collaborative works together looking at spent media analysis of a ammonia stressed choke cultures grown in an amber to fifty system so. I encourage listeners to go out and download that paper reach out to Sarah directly on if you want more information on that we are also very involved with thimble. I know a lot of listeners. And their organizations to so tradit- our involve nimble by. We have about current project. They're looking at the future. Development of what's a rebel like platform look like to attack other application spaces in bioprocessing? And if anyone has any information I encourage him to reach out to me directly linked in or email or via web site for any more information. That's great and I'll make sure that I include the linked to the paper that you mentioned in the show notes so that listeners can find that easily because I read it as well and it was a very good paper and really interesting. It'd be helpful for a lot of people so I make sure that that's in there And thank you so much again for your time. It was really interesting and a great talk and I really appreciate you taking the time today. Thanks Randi thank you for joining us for this edition of the cell culture dish podcast to learn more about this and other stem cell in bio manufacturing related topics. Please visit us at. Www DOT cell culture dish dot com or for downstream bio manufacturing topics www dot downstream column dot com..

Korla Clemson University Buckley Randi bioprocessing Sarah
"cell culture dish" Discussed on Cell Culture Dish Podcast

Cell Culture Dish Podcast

10:00 min | 4 months ago

"cell culture dish" Discussed on Cell Culture Dish Podcast

"Be labeled and sent out to an external lab or core lab. And then it's allowed just six in a tracking burden for Babar Tories on both ends up those samples but also those receiving them at running them. Additionally there's a variety of technology platforms that are required to run sample each one of those platforms and analyzers has their own separate sample. Prep Protocol and associated with that also is just the difference in sample volumes numbers recently with the advent of microbial reactor systems like hamburgers or larger facilities folding more benchtop bio reactors shake flasks labs contend with not only a large number of samples that they want to be run in a timely fashion but also the sample volumes with micro bio reactors and shake flasks. You're really limited on the working volume that you can pull out every day to run analytics on so all of those. Are the real pain points associated with spent media analysis? But if you can't do it every day or even more frequently depending on your process you get very rapid data day to day or our to our to the metabolic profile and media profile of your culture with that allows you to do is change things on the fly. If you have that opportunity you can optimize the process this faster. And if you're getting that data and real time You don't have to wait days to weeks to get that data from that core lab so you can really accelerate your process development times. Make the right decisions in a timely fashion. That makes a lot of sense that data is. You're right is so critical. And and the more timely it is the better can be utilized a to that point In September you launched the rebel analyzer to address the challenges that you just mentioned and I was hoping that you would be able to tell us what led your company to develop the rebel and then also what key features were important to include as you went about designing the product for about two years before we even decided to build the system We spent a lot of time talking with our current customers especially in the Bio Pharma. Space getting into the lab with them seen in experiencing the good and the bad of their day to day work in the lab after doing that for for quite a period of time with a lot of great collaborators. We identified a huge bottleneck from process. Developed going back to that first question just the amount of samples that are being generated and PD and the bottleneck of you know the core labs being inundated with them and not being able to turn around Hass as quickly. This all stems from a very aggressive schedules and tie mines I various research projects The burden of sending things out and also just handling the data so once. You've run all these samples. Oftentimes you are left with mountains of data and proprietary data formats and so the bioprocess engineers really struggled with how to process all of that information. Taking that knowledge we decided to design the system for where needs to be and that's alongside by reactors in the process of element lab. We noticed that other analyzers and instruments in that lab had been adapted from the Clinical Space. And so they were more or less than other gray box in the corner of the lab and by speaking with users. We learned that they wanted a more functional form factor that fit their workflows and we applied are super simple philosophy of design to the rebel. And that really is seen. And that's the rebel has no computer off to the side of it. That's needed to control it. The computer the Monitor all the interface on the system itself on a fairly large tablet There's no waste or solvents alongside the system. Everything is inside of the enclosure and that frees up valuable benchtop space to put it another. Bi-reactor or another analyzer. Next to it. There's no special power requirement have went to about a dozen labs and measured shelf heights to make sure that you know. He could fit under a variety of different shelves and ads. They could be placed on a car to move around and that the user interface is extremely intuitive so it functions more of like a phone application with alerts and notifications that are simple to address on the workflow side of things. We've really focused on having a protocol that required no extensive sample. Proper revitalization the data and the USABILITY of the system has no proprietary data formats. It's network kind tippety. And it also has twenty one so far apart eleventh compliance out of the box. It really sounds it so you spent a lot of time really fine tuning this equipment for this specific purpose and I was hoping you could elaborate. A bit on how. The rebel can specifically speed process development efforts. Because I think that that's a real key area that people are looking at as we look at things like speed to market and how to be most efficient as possible in the lab if you really focus on making sure that worth samples are originating running that analysis at and anytime a user wants to run them again eliminating that need to package samples label them and send them out of the lab. So with that you know it's not only having the system next to the bio reactors where this happens are originating but the sample prep hat to be super simple on this. So there's no labelling at all one hundred percent label free technology then once samples are put into the system with either vials or well plates. The data that you get back is not proprietary. Sister See as V file or PDF file and the results are unambiguous. The the what was detected in a concentration you can export that the recklessly onto an external drive. That's connected to the system via USB or you know if you have it's mapped out onto your network you can have your data files has they are being generated Set to a that work. Drive that you can then access At your office at home or if there's another group or a piece of software like limb system up pulling that data. It's easy retrieval. That's great and one of the things I know that Our listeners our times really interested in is How it looks in their own workflow and how would they implement this so I wanted to ask? Specifically how would use implement the rebel in their labs and then also? Is there any specific training? That would be needed. To run the rebel rebel sits alongside your bio reactors or microbiome reactors every time samples pulled. You can bring some over to the rebel and run it training as very short typically less than a half of a day having said that we've trained any groups from two people to twenty researchers today on everything that they need to do to run the rebel and approximately ninety percent of that training. Time his hands out. It's not at a computer looking at slides or in a classroom reviewing material. We really focus on getting hands on the system and learning how to run it after we leave. We have a dedicated support team of engineers scientists and data science grew stance or any follow up questions and timely fashion. Another question along those lines. Could you describe the user experience a what what would use her? How would he use her about? Using the rebel figure of everyone could reach their pocket and unlock their phone. You could run the rebel. It's a very large screen simple notifications no keyboard off to the side. It's all touchscreen enabled very limited external interfaces and maintenance you know frankly that routine maintenances emptying the waste bottle on the inside of the system and it fills up ultimately the science. That's being running the PD. Bob Is hard enough so we really focused on making the interactions and the usability of the rebel breeze. I think that's so key. 'cause I think a lot of times you know. New Technology can be intimidating. And when you have something that's easy to use the interfaces so intuitive it just makes the implementation so much more straightforward and it puts everyone at ease that is going to be using it so I think that's really important to switch gears a little bit. I wanted to ask about the rebel being used in cell and gene therapy applications because we have a lot of listeners that are interested in that area as well. Yeah absolutely we have users today. In the cell and gene therapy space using the rebel to optimize their media just as groups do with Chou Mine and fermentation processes. They're looking at the same types of end goals ensuring reproducible processes increasing equality of their products increasing be quality of the media that they're getting from outside vendors or even internally made media ultimately our users in the cell and gene therapy space have told us that they look at the biologics community and what they have fun rattled and discovered over the last decade or two about the importance of using the media to ensure consistent processes.

Bio Pharma Clinical Space Chou Mine Hass New Technology Bob
"cell culture dish" Discussed on Cell Culture Dish Podcast

Cell Culture Dish Podcast

04:11 min | 4 months ago

"cell culture dish" Discussed on Cell Culture Dish Podcast

"What are some of the challenges to developing the non animal origin supplements? The biggest challenge is to fear out loud if you're really have complete visibility on action process off a non animal origin component so We rely on Simul sucking men's awesome at eight eight said Clea Year Analysis Salon off His as the thoroughness you have audited is supply or in to the degree to which you ended sand on the of Camakers US or e facility. Whatever they use in the process that that comes together host the basis for your assessment off. What DEGREE OFF NOT So in general when we come any. Oh we have this. Definition for instance their enemy components in in our science were US or in India or amicus. A is new era of animal origin components in the manufacturing process and or in the facility at this notion treatment Orgeon materials hand club. It there is no contact with any components that come into facility is unnecessary is operatives. Thank you for that description. I think that's really helpful. Do you have anything else that either of you would like to add for our listeners. Today I really appreciate your time and I think this has been really interesting discussion and I wanted to just see if there's anything else that you would like Chad via I keep your eyes open. Sometimes I feel like keeble are too easy when they're eaten animal origin. Non Animal origin is not a reason to not thoroughly understand the process of your main doors into what you are doing with that material. It always you should always apply the precautionary principle. That's pretty much where I had to say. Essences so many definitions or free. Our annual component free or blood FREEBIE. Or whatever you have out there it is really important to understand what fire. East Asians undestands by the definition TIKI. You can find out by asking a supply. Give you a thorough. You define in a large fear editor component free if you want to include such an agent in your process you wise to do a thorough audit at the manufacturing site why to at least do a thorough audit convinced yourself pad their definition of non animal version occurs with what you had in mind. Thank you so much for that. Thanks so much for your time today. I really appreciate. It was wonderful to talk to both of you. Thank you thank you for joining us for this edition of the cell culture dish podcast to learn more about this and other stem cell bio manufacturing related topics. Please visit us at. Www DOT cell culture dish dot com or for downstream bio manufacturing topics www dot downstream column dot.

US Simul Chad editor India
"cell culture dish" Discussed on Cell Culture Dish Podcast

Cell Culture Dish Podcast

09:16 min | 4 months ago

"cell culture dish" Discussed on Cell Culture Dish Podcast

"Welcome TO THE CELL. Culture dish podcast. Non Animal origin cell culture supplement in manufacturing AIDS for biologics manufacturing. I'm Brandy Sergeant Editor of Cell Culture Dish joining me. Today is Dr Tobias Hurtig Regulatory Affairs Manager and Dr Tillman Product Manager Supplement in manufacturing and both with mark. Kgi Darmstadt Germany. I wanted to start today by asking if you could give us. A definition of non animal origin. Is there an industry wide understanding of the term? I would love to give you a definition for anymore origin or industry-wide definition of for anymore origin. Free or non anymore origin. Unfortunately there is no definition and there is no useful or clear. Definition provided by the regulator switch rate. Cipolla provide you a definition for animal origin. But not for non any minority with that in mind. What are the distinctions between primary secondary and tertiary levels for non an origin? So these determine partners attach level non anymore our Chin or animal origin. Free these terms are used to what people try to distinguish how far away they believe. The actual origin is for instance primary non anymore. Origin would mean okay. Something which is not directly derived from animal secondary on animal origin would be used when you want to say okay. He has something for instance last week. Produce Feminization and dissemination media did not contain any animal orchard material for instance recumbent insulin produced by bacteria. And if I may use the recumbent intimate as an example for tests and that could be used when you want to say okay. He is pro instantly which needs kieft into instantly by an enzyme. And this enzyme that I'm using a knot of animal origin and be also is not coming out of feminization which an arched material in media. These terms are not fully defined. So if you read about these terms you want to make sure that you really understand what the author or the user actually wants to tell you. Thank you for that. That's helpful as a basis for discussion. I was hoping you could also clarify vice for for listeners. Why is animal origin? Such a big concern in the cell culture realm let you start with why Edema or a Chin a concern. Animal origin is concerned. Typically with the from sound are adventitious agents coming with that animal material Dr However other concerns for instance dictate religious concerns halal kosher concerns around the origin. That could be lifestyle concerns that you think but we can waive alleged. Cheese are CO ever. These could also allergies. Ause topic focuses planned to proteins but they major issue are adventitious agents which could be so Nautica so they could cross the species barrier from the animal to human to the patient and causes disease with the patient These competitions agents might be viruses for instance sonars. A rabies are viruses that I've known to cross the species barrier or a protein protein-based agency like There the priors causing TSE pse. Other concerns are related to the supply situation so getting animal origin raw material. Importing that into your country could be associated with restrictions likewise she ever media produced which contains unlimited died might be import-restricted into the country. Where your customers sitting with the got to the Cell Culture? There is a another concern. And that is these the celts. The mammalian cell Kasha might be susceptible to such viruses. And if you OUGHTA robbing a nephew witcher on a bio rector unachieved g conditions. You need to tightly control your by tour and a virus might have a whatsoever effect to yourself. Kasha and from that point on your cell culture would not be regarded as p compliance. We talked a little bit about the fact that there isn't a regulatory definition of non animal origin. But I'm hoping that you could share with us. What the regulatory view on animal origin components is the regulatory few on Non Amel components is of course that this is the preferred As a regulatory person you would like to avoid any more mature whenever possible or you would expect that any moment you to comply with all the Pantin interrelations with regard to non animal materials and Lesser Regulatory Person. I feel that as much as I appreciate it. I always cautious because I don't want to end. Wishful thinking and due diligence is always required. Are those non animal materials. Don't get blind folded around the the documentation truly want to understand why this material is known in origin. So keep your eyes. Open your mind work with your suppliers as close as possible to truly understand when they talking about nine non anymore origin. Is that exactly what you want to half what you think? Non Animal Arjun is to avoid any ambiguity and confusion and at the end natives disappointment. I also feel like Worthwhile when you're auditing your vendors to question the the animal or non Hemel origin situation and to make sure that you're suppliers are in fact producing S. You wish to that makes a lot of sense and I wanted to switch gears a little bit here and ask you all work if you could talk about. Which products in your portfolio are non animal origin and also how much insight you have into the manufacturing process of these supplements so my started out as being composed of animal origin caused in the old days. A lot of just source these components from produced than from Sierra the meantime I have as a new wave the recumbent supplements which Humira he formerly Serum Soroush contributed man. So for instance. We have the incentives using schedule. When Sarah in zero we have Instead are commonly such as transferring or abdomen or growth factors to just a few incident on me and also on the on the side of the manufacturing agents high in the old days. Fever relies for instance on our sonnen trips. And in the meantime we have a complete full of Which we offer in various Varies great manufacturing AIDS is something that is typically subsidized under supplements but it's not really always supplement manufacturing process ends on the election of this recumbent enzymes is labeled as said prime recumbent supplements and everything in my portfolio. It's sad prime. A recumbent any supplement just to clarify. Would it be possible to define for listeners? What long are three is short while on three is derivative of the IT Actor which is.

Regulatory Affairs Manager and Cell Culture Dish Kasha Lesser Regulatory Person Dr Tobias Hurtig Kgi Darmstadt Germany Brandy Sergeant Chin Editor Nautica Fever rabies Sarah Cheese Hemel
Non-Animal Origin cell culture supplements and manufacturing aids for biologics manufacturing

Cell Culture Dish Podcast

06:47 min | 4 months ago

Non-Animal Origin cell culture supplements and manufacturing aids for biologics manufacturing

"Welcome TO THE CELL. Culture dish podcast. Non Animal origin cell culture supplement in manufacturing AIDS for biologics manufacturing. I'm Brandy Sergeant Editor of Cell Culture Dish joining me. Today is Dr Tobias Hurtig Regulatory Affairs Manager and Dr Tillman Product Manager Supplement in manufacturing and both with mark. Kgi Darmstadt Germany. I wanted to start today by asking if you could give us. A definition of non animal origin. Is there an industry wide understanding of the term? I would love to give you a definition for anymore origin or industry-wide definition of for anymore origin. Free or non anymore origin. Unfortunately there is no definition and there is no useful or clear. Definition provided by the regulator switch rate. Cipolla provide you a definition for animal origin. But not for non any minority with that in mind. What are the distinctions between primary secondary and tertiary levels for non an origin? So these determine partners attach level non anymore our Chin or animal origin. Free these terms are used to what people try to distinguish how far away they believe. The actual origin is for instance primary non anymore. Origin would mean okay. Something which is not directly derived from animal secondary on animal origin would be used when you want to say okay. He has something for instance last week. Produce Feminization and dissemination media did not contain any animal orchard material for instance recumbent insulin produced by bacteria. And if I may use the recumbent intimate as an example for tests and that could be used when you want to say okay. He is pro instantly which needs kieft into instantly by an enzyme. And this enzyme that I'm using a knot of animal origin and be also is not coming out of feminization which an arched material in media. These terms are not fully defined. So if you read about these terms you want to make sure that you really understand what the author or the user actually wants to tell you. Thank you for that. That's helpful as a basis for discussion. I was hoping you could also clarify vice for for listeners. Why is animal origin? Such a big concern in the cell culture realm let you start with why Edema or a Chin a concern. Animal origin is concerned. Typically with the from sound are adventitious agents coming with that animal material Dr However other concerns for instance dictate religious concerns halal kosher concerns around the origin. That could be lifestyle concerns that you think but we can waive alleged. Cheese are CO ever. These could also allergies. Ause topic focuses planned to proteins but they major issue are adventitious agents which could be so Nautica so they could cross the species barrier from the animal to human to the patient and causes disease with the patient These competitions agents might be viruses for instance sonars. A rabies are viruses that I've known to cross the species barrier or a protein protein-based agency like There the priors causing TSE pse. Other concerns are related to the supply situation so getting animal origin raw material. Importing that into your country could be associated with restrictions likewise she ever media produced which contains unlimited died might be import-restricted into the country. Where your customers sitting with the got to the Cell Culture? There is a another concern. And that is these the celts. The mammalian cell Kasha might be susceptible to such viruses. And if you OUGHTA robbing a nephew witcher on a bio rector unachieved g conditions. You need to tightly control your by tour and a virus might have a whatsoever effect to yourself. Kasha and from that point on your cell culture would not be regarded as p compliance. We talked a little bit about the fact that there isn't a regulatory definition of non animal origin. But I'm hoping that you could share with us. What the regulatory view on animal origin components is the regulatory few on Non Amel components is of course that this is the preferred As a regulatory person you would like to avoid any more mature whenever possible or you would expect that any moment you to comply with all the Pantin interrelations with regard to non animal materials and Lesser Regulatory Person. I feel that as much as I appreciate it. I always cautious because I don't want to end. Wishful thinking and due diligence is always required. Are those non animal materials. Don't get blind folded around the the documentation truly want to understand why this material is known in origin. So keep your eyes. Open your mind work with your suppliers as close as possible to truly understand when they talking about nine non anymore origin. Is that exactly what you want to half what you think? Non Animal Arjun is to avoid any ambiguity and confusion and at the end natives disappointment. I also feel like Worthwhile when you're auditing your vendors to question the the animal or non Hemel origin situation and to make sure that you're suppliers are in fact producing S. You wish to

Regulatory Affairs Manager And Lesser Regulatory Person Cell Culture Dish Kasha Rabies Dr Tobias Hurtig Kgi Darmstadt Germany Brandy Sergeant Editor Chin Cheese Hemel Nautica
"cell culture dish" Discussed on Cell Culture Dish Podcast

Cell Culture Dish Podcast

11:04 min | 7 months ago

"cell culture dish" Discussed on Cell Culture Dish Podcast

"Substitution of idea pitching. Tell us how the supplements are being used. Supplements are being used as raw materials for manufacturing New Year France Typically Growth Factors Leica. Recumbent insulin on long three are added to the set coaching media. Either by the manufacturer in from Beijing or they are at an as ten known to a medium that customers typically source and they added on their own from a standalone product and then added to the media shortly before us either once said Proteins are used to manufacture media for education such as that which is very close to humans. Where you basically expand Relations that you then in in fuse into another us is the aforementioned manufacturing mentioned for instance troops in as used in the course of the manufacturing of recumbent therapeutic insulin that was typically carried out before using go vinyl concentric and today in in the market other word wise producing big companies on now at the stage where the trying to replace or central to whenever possible and use reconnect Trabzon. Instead could you share with us? Are there differences between monoclonal antibody and recombinant protein manufacturing verses Regenerative Medicine Gene Therapy and vaccine manufacturing when it comes to the supplements use? Yes in the ticket groom Montel. Anybody recumbent protein process talking a Mug. skewered process of thousands of leaders off said gushing media and people have been trying to reduce any any extraneous components in India and also in the process of recovering. The product from those Yida is important to not have any Continues Agency knitted conferences contributed? The ceremony? Might complicate the purification processes so in those applications where you have not tear media for production of antibodies other recumbent trunking section is going like this it is mostly the growth factors that are recommended. In a three way supported the growth the health and production off he designed product on a small scale in this therapy realm. You typically have using serum components just in lack of a suitable replacements and people bigler slowly getting around to using recombinant sediments in there as well and also manufacturing as for instance. If you think about the extension of Thomas stem cells some of these products says the grill on supports sneaked off. His stick supports for off the microbes that they go on and in order to extend his nation's yet go through the teen splitting the sounds and in order to keep the risks no The recumbent preussen issues in this cases that I wanted to address something that we hear sometimes in the industry which is that Clinton derives supplements are the answer to all of the industry's woes Could you address that statement? Our that relief that we sometimes hear yes. People always think when something comes from implant it is automatically non animal origin which obviously it'd be Thrived pice at you. Have to go see no cat. manufacturing process can use crosses and also since a lot of these products are known in the field on under controlled conditions. Have to look at how controlled addy's dishes are de Instant sheddings from animals. Either birds or Fox or house when Edmund in Newman's at might introduce contamination in an otherwise spent running so it is not a cure all loose. I wanted to if there's a difference in performance are g think between the non animal origin and the animal origin supplements. We don't think that there is difference in prominence as as I mentioned before issues. For instance certain percentage of Sarah in your medium besides the fact that Ed attention source community. She is undesirable agents. You're also interviews a load of protein. That she don't want to have in your process when you trying to Purifier way you desire in terms of performance issue and a half years something. That's the right concentration. Which OFFERS IS DIFFERENT FROM. Sal Airline and expression system than you can titrate girls concentration that we supply samples estimates used among their own for making up their own formulation or we also offer section year such as the seniors by sending on Kenmore media at contain already known of these groups and that works out has been cited of course. I'll do custom formulations. According to customer at recipe has that end inevitably specified? They want to be the transplant protein or a recovery of human transferring depending on. What are some of the challenges to developing? The non animal origin supplements the biggest challenge is to fear out if you're really eat half complete visibility on the knife etching process off your non animal origin component. So we rely on Simul are sucking awesome affectionately. Eight cents ethnically year analysis non His thoroughness which you have additives is supply In to the degree to which you ended San under the chemicals use or production facility whatever they use in the process that comes together and the basis for your assessment of what degree not ours. You're so in January when when we come any all we have this For instance that they're on animal components in our that we use are in the media or a chemical is Louie reuss of n widow origin components in the manufacturing process and working at this notion treatment with animal. Arjun Materials Club that there is no contact with any components that come into facility other than the union's unnecessary as race. Thank you for that. I think that's really helpful. Do you have anything else that either of you would like to add for our listeners. Today really appreciate your time and I think this has been really an interesting discussion and I wanted to just see if there's anything else that you would like Chad. I Keep Your Eyes Open. Sometimes I feel like people are too easy when they read on animal origin. Non Animal origin is not a reason to not thoroughly understand the process of your main doors. And what you're doing with that material an it always. You should always apply the precautionary principle. That's pretty much where I have to say. So many definitions or you. Our annual component free or blood free. Or whatever you have out there it is important to understand what a fire. East Asians and a sense by the definition you can find out the by asking a supplier. Give you a sorrow of you when you find in a large fear. Anger component free if she wanted to include such in aging in your process wise to do a thorough audit manufacturing site why to at least do a thorough audit convinced yourself that they're the finishing non animal foraging occurs with what you had in mind. Great thank you so much for that. Thanks so much for your time today. Really appreciate it was wonderful to talk to both of you. Thank you thank you. Thank you for joining us for this edition of the cell culture dish podcast to learn more about this and other stem cell and bio manufacturing related topics. Please visit us at. Www DOT cell culture dish dot com or downstream bio manufacturing topics www dot downstream column dot com.

Beijing Regenerative Medicine Gene The France Leica trunking India Montel Yida Louie reuss Arjun Materials Club Sal Airline Clinton Simul Continues Agency Sarah Chad Ed Fox
Non-Animal Origin cell culture supplements and manufacturing aids for biologics manufacturing

Cell Culture Dish Podcast

08:31 min | 7 months ago

Non-Animal Origin cell culture supplements and manufacturing aids for biologics manufacturing

"I wanted to start today by asking if you could give us. A definition of non animal origin. Is there an industry wide understanding the term? I would love to give you a definition for animal origin or industry-wide definition off for animal origin. Free or known anyone origin unfortunately there is no industry wide definition and there is no useful or clear definition provided by the regulators typically provide you a definition for animal origin but not for non any minority with that in mind what are the distinctions between primary secondary and tertiary levels for Armando origin so the the temps primarily they're attached level non anymore origin or animal origin. Tree these terms are used to what people try to distinguish how far away they believe. The actual origin is for instance primary non. Anyone origin will mean is something which is not directly derived from animal. Secondary on animal origin would be used when you want to say okay. Here's something for instance. Last Produce Feminization and feminization media did not contain any animal arch material for instance recumbent insulin produced by bacteria. And if I may use the recombinant insulin as an example for tets sherry animal or if that could be used when you want to say okay he is pro insulin which needs became instantly and by an enzyme and this enzyme that I'm using. He's a anymore origin and be Also is not coming out of temptation. Which had an arched material in these times are not Foley defined? So if you read about these terms you want to make sure that you really understand what the author or the user actually wants to tell you. Thank you for that. That's helpful as a basis for discussion. I was hoping you could also clarify advice for for listeners. Why is animal origins? Should be concerned in the cell culture. Realm let me start with. Why animal origin a concern animal? Origin IS CONCERNED. Tubular. Typically from sound are adventitious agents coming with that any material. Dr However other concerns for instance dicap- Religious concerns allow kosher concerns around the origin. That could be lifestyle concerns shifting but we can waive LS cheese our topic. However these could also allergies. Are ause topic for France's planter. I've proteins but they major issue are adventitious agents which could be so Nautica so they could cross the species barrier from the animal to the human to the patient and cause disease that patient These competitions agents might viruses for instance SARS rabies virus that? I'm known to cross the species barrier or a protein based agents like the the priority causing tse pse other concerns are related to the supply situation. So getting anymore origin raw material. Importing that into your country could be associated with restrictions likewise she ever media produced which contains enormity died might also be import-restricted into the country. Where your customer sitting with the got to the Cell Culture? There is an another concern. And that is these the cells the MAMMALIAN cell Kashem might be susceptible to such viruses. And if you are robbing a off you wished you're on a buyer actor unachieved conditions. You need to tightly control your by rector and a virus might have a whatsoever effect to yourself. Kasha and from that point on your cell culture would not be regarded as GNP compliant. We talked a little bit about the fact that there isn't a regular trade definition of non animal origin. But I'm hoping that you could share with us. What the regulatory view on animal origin components is the regulatory few on Non Amit components is of course that this is the preferred situation It's regulatory person you would like to avoid any more mature whenever possible or you would expect that any moment you to comply with all the patent interrelations with the gods to non anymore materials and there's a regulatory person. I feel that as much as I appreciate it. I always see cautious because I don't want to any wishful thinking and due. Diligence is always required. Aren't those non animal materials? Don't get blindfolded around the documentation. You truly want to understand why this material is known in Mauritian so keep your eyes open. Keep Your Mind. Open work with the suppliers as closely as possible to truly understand when they talking about non animal origin. Is that exactly what you want to half what you think? Non Animal origin is to avoid any begrudge. Any confusion and at the end may terms disappointment. I also feel like it was worthwhile when you're auditing Uranus to question the the animal for non GMO origin situation and to make sure that you're suppliers are in fact producing S. You wish them to that makes a Lotta sense and I wanted to switch gears a little bit here and ask you work if you could talk about which products in your portfolio or non animal origin and also how much insight you have into. The manufacturing process of the supplements might be started out as being composed of animal origin. caused in the old days. A lot of people just Sourced components from produce them from Sarah. In the meantime. I have as a new wave. The recumbent supplements which Humira he formerly Serem source erm contributed. Mansell so for instance. We asked the using feasible when Sarah more in the hemisphere we have At are commonly such as transferring or at Newman or growth factors to just a few incident on all three and also on the on the side of the manufacturing agents in the days feeding relies for instance on core sonnen tricks. In the meantime we have a complete fool of which we friend Aries greats manufacturing AIDS is something that is typically subsidized on the supplements but it's really Orissa. Supplement manufacturing process ends on the collection of this recumbent. Enzymes is labeled as said prime recumbent supplements and everything in my portfolio. It's Dunston said prime. A recumbent and any supplement

Non Amit Sarah Armando Foley Mansell Nautica Dunston Orissa Kasha France
"cell culture dish" Discussed on Cell Culture Dish Podcast

Cell Culture Dish Podcast

10:13 min | 10 months ago

"cell culture dish" Discussed on Cell Culture Dish Podcast

"Dosing By giving the sells their own sauce about song to kind of similar sites. Kind which means that. The patient doesn't doesn't have any systemic exposure to that size to con- it's so the needed that she has sought to come and present and they can go to work on their own without leaving the patient additional doses of constantly keep those cells alive the longest so we cannot eliminate that can do that. We can for example the treatment more accessible because you can treat the patients that don't need those filed suit supports necessarily for treating patients We can actually remove that piece of the equation that she making a much better people as patients at the same time providing those cells with their own POW pack that we cannot those far on demand that they small molecules the more. I'm going to be using Ruby centers on my one We can also make those sales more road. Boston persistent of the Cheema seismic spent more active and chainsaw as well else that'd be kidding chambers. And secondly they need that sought console which some patients have difficulty Managing about doc so patients central patients who would normally be eligible for shelter. These go into that because of the conducive science concepts meditation. I picked the right day to ask that question. That's great Wonderful News it's really interesting and look forward to reading more about that. As that progresses to Kinda follow along or get back to the cancer piece that we were talking about. I'm wondering if you could talk a little bit. Broadly about what role you see for precision medicine in cancer care overall. Will I think it's it's something that is going to be full. The future and Forty seamless accessible college. He's just about to syrup. Approach that we're looking at here They're all the cell types for example is natural killer cells where if you to be able to and help them persistent grow In the body and control that persistence with this kind of known as I o fifteen which we at. Let's see all working on their city. We can control that activists you I'll fifteen so. For example we can control the activity activity of natural killer cells and improve that for patients and the number of cell types that we can use to treat reeks patients with some Schumer's and I think it just comes the approving of the patient the become eligible for cell therapy treatment because of precision medicine. But also you're gonNA see a broadening in touch the cells that can be used to To treat these patients which gives the more accessible I think ultimately making this medication more accessible for patients go that we want to achieve. That's great what is next for Obsidian near term and then you talked about obviously the this on your big announcement and what's going on today. But what else awesome horizon. What other indications are you looking out? What's coming up for the company? So that's a good question One of the Nice things about a platform like right. This is it. It sounds really we build a lot of opportunity to choose Diseases where we believe that Regulating seventeen so he's can make a difference You know you can look at things like you can look at Mulji We can look at other cancers dances apart from the ones have been looking at right now. so I I can see that. There's quantum number because he states that we can We can talk at the White House. Think about technologies as a pro team that you can make we can regulate it And we can also regulate it than any cell tide. Whether it's the patient's own cells or describes Elian off the shelf sell time so we have a very drooled platforming centers of APPLICA- ability. Actually triaging that so those opportunities you set right now. It's not just by her grounds for our own internal pipeline. So I think you'll see more announcements about what we're doing with our own internal pipeline. Second thing is we all in discussions with numerous other companies in the SANJIV. Alan team coach he space about trying to ply type outfit today technology and vice versa. Eventually we'll be doing selected taller ships as we move toward the WHO wants to focus on what's important full pipeline as much as possible We making great progress to that still slash ashby. Ns Lines right now. So I expect you'll see some Milestone updates on on this removes towards and then a company they like that just require financing so we expect to be doing another financing in the next twelve months prior to taking this company out to and probably the public markets about two to three years older company which you set internally to be in the clinic with this technology well she by twenty twenty two so that's not just I would see as a way so we're very focused now on taking this technology into the clinic firm you too and also on great goal to have and wish you the best in that where would you be in five years and kind of is there precipitate strategy that you're taking moving forward. I know you talked about. Obviously there's so many opportunities of this platform is there anything specific that you will be utilizing in terms of strategy to to manage all that I'm a huge believer in strategic planning. So we've the management team working on that right now The opportunities that we have in five years time I think will include Having a commercial products on the market to treat patients with But Kansas so this is the program that could be coming within about two years time. uh-huh moving five years time should be at the point where it could be used to treat patients in a commercial setting so we have to stop thinking about how we GonNa do that We gotta be broiled NIA pipeline. That's for sure I think we'll have multiple partnerships in place in this country and potentially other countries as as well and we should probably be a publicly traded company at that point in time the company's. I'd like to look out as sort of role models for a company like city where they have a really strong platform play develop products include companies like L.. Nine on which is a local company. Me Here is quite famous company and we met you just picked up ahead of human resources. Came to this from El Nine and so we're going to build a team aimed to replicate does success in the next few years. I've really appreciate your time today. This is really interesting. Thanks so much for sharing your story and Obsidian Story. I just like to close by asking. There's anything answer to like to add for our listeners. Before we say goodbye well if the bank's prime one thing I would say is that business is all about people They all the county of life and we built a really strong team here. I'm sitting. We've had a lot of new team members. Join us in policy amongst and everyone's really energized and working very hard to bring this Technology she into the clinical setting as quick as possible. We have an obligation to do that. And we've assembled a team that's really moving very quickly now. Working very hard to make that happen The second thing is that you know these benches like this require Somebody would willingness to place bets. Let's on this type of zone out season in fantastic tools atlas have been tremendous we have google ventures in the company. Anthony AMGEN TAKEDA BUT SEX. I mean and others but it's actually really nice to have a very high level support not just from the tables from that board as well if you're working tonight. This is really about thanking over people to help put into place On the team here sitting as well that we're here before I joined Able to develop his platform to a point where we were ready to pull the trigger on identifying the candidates and development development programs and some of those guys have been hip in eighty four years and to now they're saying the dream son inch reality which is just tremendous. Padilla came about because awkward. That's exciting to be able to see. All your hard work come to fruition. I'm sure for those folks. It's just really thrilling. I couldn't agree more. It's all about the people so I think that's great Thank you so much again for your time today. I really appreciate it and look forward to keeping up on obsidian and following what. You're you're working on moving forward. Thanks Brandon Good Luck. Thank you thank you for joining us for this edition of the cell culture dish podcast to learn more about this and other stem cell bio manufacturing related topics topics please visit us at. WWW DOT cell culture dish dot com or for downstream bio manufacturing topics www dot downstream. ON-STREAM COLUMN DOT.

Boston Obsidian Story El Nine Schumer Diseases Anthony AMGEN TAKEDA Elian google Able White House Brandon Kansas APPLICA twenty twenty Padilla NIA
"cell culture dish" Discussed on Cell Culture Dish Podcast

Cell Culture Dish Podcast

04:24 min | 1 year ago

"cell culture dish" Discussed on Cell Culture Dish Podcast

"Well and i wanted to follow up at that what were the drivers behind building a facility dedicated solely to eighty cs and other bio conjugates although bad concave <hes> subset of reads a ban logic therapeutic take my pay rivera researcher poet gathering data from worldwide panini try. I've shown young you increase increase in the number of a._d._c.'s and other conjugate injuring coninck trys o five years by rodney throw percent year a year some estimate that komo shoe sales so a._d._c.'s could grow twenty two percent avenue the next five to ten years in addition based on drug company pipeline data issue appears adverse trend will continue into the foreseeable future as our mission is to provide otis drug development platform so that every drug can be made an every disease can the treaty and he gave me our expertise capacity and the resources we've been knee. We provide a single source of product development and the supply. I changed companies. Developing low therapeutics are tracking here to j._d. Thing man we by john trio providing incentive dogs development and manufacture services while kind of the villa the whitewater right now hundreds from idea g._m._c. manufacturing for clinical study thing have home by the <hes> services for you live ninety firing that has and the remaining five percents off the telephone founding founding for a._b._c.'s lay in to govern eighteen last year actually in new guinea they have the increase in manufacturing affection capability <hes> happening for both the ad and she now we can need the increased need for coming quantified inundating fine and new impact well. That's quite impressive. I'm really interested you mentioned that you could provide a single source for all bio conjugate needs. I know that a._b._c.'s and other bio conjugates are complex molecules with both chemical and biological components and how are you able to provide all the services required to get from early discovery to clinical supply and then are there any gaps in that <hes> we keep our will no i really take kind femme from the community on study for antibody their airport and we're our expertise and the single source services kebob hiding to us and the other lender however ah you mentioned there are chemical panel dependent being you know more about conjugates and even though she is not a separate green company and member of the attack group of companies you work very consciously these are original parent company snee- bob and that's happened in discovery chemistry development and the manufacturer alpha payload incas singers. You know dacian we allow the worc- pack alive the essential preclinical promises insist such as the r. e. n. p. oncology research and the on stage and in neighboring poxy college studies and the essential services and the entire high chen <hes> reading and i that how a <music> a taco arthur driving away from each other they can home. I've thing in time and also risk reduction or any company in their doc comes on top of the hour bringing formation of being tired of entities. We'll be sure.

a._b._c. rivera product development a._d._c. researcher rodney komo r. e. n. p. oncology poxy john trio snee twenty two percent five years ten years
"cell culture dish" Discussed on Cell Culture Dish Podcast

Cell Culture Dish Podcast

15:38 min | 1 year ago

"cell culture dish" Discussed on Cell Culture Dish Podcast

"Expertise. This is in upstream processing prior to joining g healthcare. Undress was director of upstream development at swedish orphan bio veteram a._b. Working with development of expression systems process development of microbial and mammalian cell based processes and scallop to see g._n._p. Manufacturing scales during the last twenty years andrea has held several positions within biopharmaceutical development including project and line management as well as manufacturing. I wanted to start today by asking what makes perfusion good manufacturing platform for me. There are several reasons to to go for fusion perfusion allow short residence time in the reactor continuous addition of fresh medium and the removal of service and that's makes it of course suitable for unstable q. <hes> perfusion allows to run close assise also with with high magic productivity by maintaining heist okay so densities over a long time with many opportunities for process intensive case and perfusion can be a convenient way to quickly get get started with your production of material given that you have a good batch medium. The sounds like are there specific product types or situations that are in especially especially good fit for perfusion. Oh yes yes. They're all <hes>. I see three -arious. One of course is the production of of unstable products this as mentioned inching before <hes> then there is integrated continuous manufacturing platforms. That's leverage the high of the metric productivity and the continues harvest upstream is connected to continuous downstream operation. Finally there's all types of process intensification intensification for removing bottlenecks <hes> that could be in southbank manufacturing to produce high for them to sell things it could be in the trains range to a bit <hes> c. train stages all produce the inaugural on and finally it could be hybrid prophecies between and fusion and with respect to a profusion processes <hes> could you describe the importance of optimization and then what are the various approaches for optimization. Yes optimisation is of course very important to gain the product quality and the process they call them. Be that that you're aiming at the soccer. Medium here is of course the most important component or device in order to get good throughput in the optimisation it needs is to be performed in a in a state of however. They'd results needs to be verified by a reactor conditions that could be then in the in an amber or as we use the the waves twenty-five system. I saw a recent poster that you presented at in in this poster you you discussed the development of perfusion specific media. I'm wondering if you could discuss a little bit about designing medium that supports low oh a cell specific perfusion rates and also could you explain what cell specific perfusion rate is and why a low one would be important. Yes i want to start with explaining what specific perfusion rate is. It is the volume of of medium that is at its it's pastel and <hes> so let's assume you you have a medium that supports a specific perfusion rate and i i call this the c._f._p. Are all of fifty and if you want to run the process at thirty billion cells per hour you'll metric perfusion rate that the bio reactor autumn's today will be one point five. If you want to use the the same medium <hes> and from the process at hundred million south timeout you will need need to have a volume metric few rates of five reactive audience today and that is of course <hes> unfeasible in production situation assuming that you have <hes> a medium with a better depth and which allow us to to to run of south pacific fusion rates of ten not talking silent they the same cell densities of thirty million south prairie my other result and we'll point three react up all day hundreds million sounds that's promo would result in one wrecked of today and that is of course <hes> a feasible sustainable manufacturing process and i'll i'll recent work we investigate it's screeing methods to develop media that allow a very low e._s._p._n. I'll starting point the the the based on medium and we screened <hes> different feet solutions that we call cell tooth and bech smolts the south boost with a positive impact with i'm taking to me study and twin spin tooks that is up pseudo perfusion conditions the result it and from relations that were then taken to iraq for fusions in wave or in the the d._r. That's really interesting and thank you for explaining that. I had another question. This is something that comes up. I think a lot in terms of media in general and that is what if you already have a medium that your cells are performing well in. Can you turn a fed batch medium into a profusion decision medium. Yes transferring a fat batch into the fusion process. Something i got many many questions around the they methodology that that that i described on the poster works actually very nicely for taking fetch meet with with its seats <hes> into perfusion medium and by the way we we also published a paper on this topic a month ago when biotechnology progress together with a with a coop commune <hes> where we did this for two cell lines and three setbacks media and and and so it's it's it's definitely a something that that can be easily be be accomplished with the with the methodology described and i just wanted to say for our listeners. I will have links to to the poster as well as i can get a link to the paper and post that in the show notes as well so you can easily find those references that addresses referring to how did the methodology work in the case study that you presented in the poster. The first thing i want to mention is it's a very fast method. The bench screening takes basically owned the only one week and the suda perfusion <hes> design experiments study two weeks so so within a month. You have the composition for a for a fusion medium that fits your your clone own. That is your production line. <hes> we use these smith all the chief for for two media active pro and and c._d._m. Finance zero so <hes> for our internal has been producing that line both media where where in bi-reactor fusions and foot boasts us media <hes> we could cheese <hes> c._s. biaz below twenty peak elites up a day and when we were pushing one the we could put even get down to just haven't peak liters per day at the same time <hes> the south pacific productivity was comparable talk to us that we were seeing in chicago so <hes> pushing down the the amount of media profuse the iraq that taught compromise the productivity when of the other things i really liked the poster was the case study used small scale models and then entrance for the process to a fifty liter stirred tank bio reactor. I was wondering if you could tell listeners. How predictable was your chosen scaled down model. We use they develop media from from the spin soups to perfusion by reactors well the the waves twenty five has been all working horse so the waste twenty five <hes> allowed us to to reach more than two hundred million themselves per firm out in addition to the p._d. Scale for fusions. We also stayed up to the to the next fifty <hes> bi-reactor with with t._f._f. T._f._f. Spin to model was suppose very good for predicting most partly. That's like the peak these <hes> <hes> reached the titus q p growth rate c._s._b. Are the glucose lactate metabolism off malaria and product quality like like charts variance and accurate gates <hes> however the model was not perfect doc <hes> for predicting the thomas the tank mates <hes> met mataafa missing even for the like in distribution <hes> <hes> we saw some subtle differences between the spin shoop and the p._d. Escaped by the way for the the let let later the p._x. P._r. and then how predictable was your performance between your process development and fifty liter scale the performance foreman between the the twenty five of the fifty perfusion boss was very good for for actually <hes> both <hes> gross relate late to <hes> metabolism related and finally protrude. I wanted to kind of switch gears a little bit. We're talking a lot about media. The optimization but another approach to optimizing perfusion processes is to optimize the equipment used in the process in another poster that you present a sack you present the use of hydro cyclones for cell separation and i was hoping you could describe a little bit about how hydro cyclones work why they make an attractive active alternative to traditional separation devices. Yes yes definitely <hes> hydra sykes on is a device comprising the thing all the cylindrical and conical part enabling essentially fuego separation provided by the by the feet suspension shen introduced tangentially at high flow rates into the into the device so the the absence of of rotors or moving parts apart from its compactness makes us an interesting alternative to confucian long term operation so now where it's a simple device <hes> that smoked prone to clogging or seething effects that is usually seen with with sedation based devices. What were your experiences with the hydra cyclone in your case study <hes> we investigate that separation efficiencies from fees at a different slow rate to some concentration and integrations of all of the hydro cyclone with the bio reactor. We found that's all seventy to eighty percents could be achieved with the current hydro sites on define. We run a fusion process in an extra fifty buyer react at fifty million south. I'm out faw for more than two weeks <hes> in in a very stable conditions sean so <hes> it was a very very successful <hes> test both of the device yeah thank you. I thought it was really really interesting to read the poster. We've talked about several different optimization methods but i wanted to come back and summarize a little bit if companies are limited time and the resources for optimizing their perfusion processes. Do you have some advice on what you would focus on. I it's it's definitely the medium that you should focus on <hes> as explained is this e._s._p. Are or or a low see s._p. Are the key to reaching high voter metric productivity low. Hello hello metric fusion rates and high product concentrations and as a result good process economy then you can consider consider what could be a relevant production scale and how you could leverage profusion to decrease the production skate and the biotechnology pro. Oh chris publication. I mentioned we showed that the waves twenty five college quickly operated for almost thirty days at v._c._d.'s between eighty eight hundred million south sounds program out in the largest southbank at working volume over twenty five liter. The reactor can easily live about forty grams of maps <hes> today. Thank you so much. This has been really interesting and i think profusion is such a important manufacturing process ticket sitter and moving forward. I expect we'll see more and more perfusion processes in the industry. Do you have anything else that you'd like to add. Sorry mr before we close for the day yes before moving into perfusion. You should ask yourself. What makes most sense for you. What does your infrastructure. What are you prerequisites. What is your platform and previous knowledge. Then you can decide where perfusion makes most sense in your process whether it's in south manufacturing c. train or your production by reactor the medium of stem the most important factor to work with. I hope i have given you the feeling that it is not difficult to use existing medial fell to develop a fusion medium that fits your your clone in this this message however is adding new components <hes> all the time and making the medium richer and richer before for moving into a preclinical production i would recommend to discuss the medium with your high loan application specialists to see the of components can as well be removed that just to decrease for example majority but also discounts the manufacturer ability of the medium for for the gala but yes thank you so much this as i mentioned it's been a really interesting podcast and i really appreciate. I think these are a lot of questions that people have about optimizing perfusion processes and i think it's a really good information to get out there that you can take f._a. I batch media and make it into a perfusion media and i think that that's really important so as i mentioned all of the posters we discussed discussed and the paper we'll have links to those in the show notes so at people can access those easily. Thank you so much. Thank you again for your time today. Thank you very much for having me..

iraq soccer andrea director chicago foreman v._c._d. chris publication fifty liter two weeks twenty five liter twenty years forty grams thirty days one week
"cell culture dish" Discussed on Cell Culture Dish Podcast

Cell Culture Dish Podcast

11:19 min | 1 year ago

"cell culture dish" Discussed on Cell Culture Dish Podcast

"We're doing that with protein eighteen. <hes> protein simple l. a. platform is looking at leveraging developing application of for in processed testing and really tracking your therapeutic beauty products on how that's doing on the uptick in downtick of exogenous cited kinds or proteins culture in addition to that some of the other exciting things things even outside of of <hes> of just doing conventional in process testing but leveraging the similar assets like <hes> the ele- from from protein simple oh to to actually use it as a potential q._c._i. That's number one but also number two is that there's a potentially even doing you know patient in tracking in the future to look at site to kind of release syndrome and and looking at you know tracking you know how those <hes> those there's either those t cells from cell therapy product is performing in vivo so that's something that we're really excited about. I two that last point <hes> we beat signed a major public agreement with a company in china called micro point that <hes> intends to do exactly that in that market they're going to be utilizing raising our our ella platform <hes> to develop a couple of serotonin release assays that will be broadly deployed loyd in the chinese market <hes> you know along with <hes> with the <hes> immuno therapies so <hes> it's very exciting time for us listen and we've had a lot of interest from other companies <hes> since we announced that deal <hes> in in the u._s. in europe as well so <hes> we see this. This is a valuable tool. It's really the only way to to get fast accurate data on on patients kind levels <hes> during treatment so <hes>. It's a very important tool. I think for the for the industry as a whole yeah then just to build up days pointed it really oh yes i mean this is something that that people are learning within their process. Well as how that therapeutic processes is kind of behaving as go go on and manufacture these cells for for for the patient as well as patient tracking some of the things that you could elicit from just monitoring the workflow. Oh and let's looking at exogenous cited kinds of proteins is is about that potentially will dictate. We're therapeutic can help and the you know the efficacious nature of that there appear product at at the end your process but there's also some challenges right now because it's such an it's such a new field that a lot of people are constantly publishing new new and novel ways to either acting expand t-cells new subsets of t cells that are more efficacious or <hes> you know new new you know <hes> <hes> sakon cocktails that can that can drive that drive cells in different directions and really it allows by technion in us to be more of a a flexible provider as we begin to learn within within the space <hes> with our customers and so some of the initiatives overdoing doing within selling gene therapy is offering more customer services does allows us to work with customers that you know maybe a standard product doesn't work for workflow <hes> maybe it's not conventional three and twenty eight that they wanna activated t cells and we have the ability to draw down from from biotech biotechnology's portfolio unspecific aren't systems protein catalog to really plug and play different proteins or sigli modi's on the surface of you of clouds for instance to drive different t cell fina types <hes> to drive you know different performance metrics that process engineers are very are interested in within the within the cell therapy space so i think there's there's something to be said for for us. Being you know flexible to allow love people to work work with process engineers to develop products not just within a standard product workflow foot but also more custom opportunities to allow them to expand <hes> <hes> and and really drive their therapeutic cells in the direction. They want to go yeah. I think that's a really important point because i think <hes> to your cheer point wait shawn about learning with customers you know i hear over and over again <hes> particularly in the cell and gene therapy space how important it is to partner with suppliers because because it's not like you know your standard <hes> monoclonal antibody where you have a platform process in you can still have the opportunity to work with suppliers suppliers but it's it's more well defined and you can <hes> you know you sort of know what you're going to purchase and how it's going to work and you have all these tools available. Oh boy i think in this space it is really important that <hes> that learning happens between a customer and supplier because i think that's how things advance and how we we have new products and things like that so it's terrific and i i love to hear that by technique listening and and and working was their customers to develop new innovative products exa lake. You mentioned <hes> because they think right now <hes> maybe the industry doesn't fully know what it needs yet an as you mentioned with <hes> the work that you're doing there are opportunities where brand new product stink can come onto the market that address a completely unmet need. I'm and i think that that's a really exciting opportunity that this industry permits that maybe not as prevalent in in the more established kind of monoclonal antibody space to follow up on that and dave is going to ask you as biotech moves forward with the initiative. What do you see as the biggest hurdles and the biggest areas of opportunity insulin gene therapy manufacturing well. I you know i think not just for by technique for all the tools providers <hes> the biggest hurdles will be the ability to scale regent manufacturing to meet industry demand. I mean there's so many products entering clinical trials dell's around the world that even a modest level of success is going to result in geometric growth is not exponential growth in demand end for g._n._p. Reagents <hes> and you know that kind of capacity very capital intensive to build it has long lead times times and it's not as simple as just brick and mortar and stainless steel either you have to have the capabilities the expertise to be able to to scale these reagents <hes> and get the equivalent performance that you did when you made them in small batches so <hes> these are big challenges is for the industry as a whole but fortunately i think by technical we have the technical ability certainly <hes> to scale all up and drive yield improvements with these reagents which also has the ability to keep costs under control of course we have the financial strength to to be able to invest quickly <hes> to increase capacity <hes> to to cost effectively produce these reagents and and you know the ones that emerges the greatest demand anyway <hes> which is sometimes a bit tough to to tell because as the as the industry matures <hes> what kind of cited kinds shine alluded what what exact antibodies <hes> are going to be needed to produce g._m. P small molecules <hes> that's a little bit unknown at this point so we try to stay flexible and <hes> like i said we have the capital and the and the technical capabilities abilities to scale as industry emerges and then and just a build up at dave's point. I mean this is and you know one of the things when when we're we're we're making investments in very capital intensive market is that you know we pride ourselves. We stay very close to our customers so we make the appropriate investments when when and we need to <hes> and so that's something that you know we're we're very much invested in in our customers within selling gene therapy so to make the appropriate capital investments i would say we're trying to shoot where the rabbit is going to be and <hes> and i think you know we're we're thinking ahead <hes> as to how the industry is going to develop and mature and what are the needs going to be two three years from now well i think that's that's really an important point in any direction to go and i it's such an exciting time <hes> in the industry and i really appreciate you coming and talking with listeners about all the interesting solutions lucians and the different various challenges and workflows and and what you've developed to address those those needs i wanted to close by asking <unk> is if you have anything that you'd like to add a for our listeners. I think if they had one key takeaway for our listeners is i. I would strongly recommend that that they stay close to buy techni if they're in the cell and gene therapy space i think we will emerge as the innovator leader in developing you know the highest quality and most reproducible cost effective solutions <hes> for this industry. We're completely committed. Mid this space <hes> and i think it's just the beginning of a long and exciting journey. I mean it's it's one thing to have <hes> feel comfortable with you know closed systems and automated methods that <hes> kind of cookie cutter that seemed to fit and work well when you're <hes> in small volumes preclinical. It's another thing to think about scale and i think the future is going to be best to breed open system platforms it forms <hes> that are going to allow customers to plug in play solutions that work for them and <hes> and we are going to be <hes> right right there at the at the front of offering these these types of solutions we will emerge as as the leader in this space. I think he will see over time nine sean. I don't know anything else you want to add to that but yeah i'll add a couple of things you know for for the listeners and specifically typically the process development engineers and those are sitting on the bench <hes> is that come to us in and bring bring us your most difficult problems and the things you're trying to solve and we'll solve them with you. We're extremely innovative group and we're we're always looking to stay close to the problem statement and do things together as we begin as his market begins to evolve and we're entirely committed to the space solving the critical challenges within the cell and gene therapy market as as <hes> as as as time progresses <hes> and we are excited to be part of it that sounds great eight and <hes> i really appreciate your time today and thank you so much for joining us branding ray.

dave europe technion china loyd exa lake partner dell sigli modi two three years
"cell culture dish" Discussed on Cell Culture Dish Podcast

Cell Culture Dish Podcast

14:41 min | 1 year ago

"cell culture dish" Discussed on Cell Culture Dish Podcast

"Podcast expediting cell and gene therapy workflows workflows. I'm brandy sergeant editor of the cell culture dish joining me. Today is mr david ensor president of the protein sciences segment and biotech need and and dr shawn kev leeann senior director of cell and gene therapy bio technique. They're here today to talk about new technologies that can be implemented to expedite selling gene therapy workflows and facilitate the path from bench to clinic the cell therapy industry holds much promise but also has faced challenges in manufacturing and commercialization dave. What do you see as the biggest hurdles of the industry must address in order to successfully move more products to commercialization the station as well brainiac see at least two significant hurdles for the industry <hes> i i think since he's therapies earpiece are chiefly autologous second and third line therapies for relapse refractory patients at this stage. <hes> you know the the the patients may not respond as well as if they had received therapies earlier perhaps and <hes> the results may be that that some of these <hes> some of these therapies may not make it through the clinic or take longer than they otherwise would to get to market so i think that's one significant <hes> hurdle another. I think is cost <hes> as everyone knows. These therapies are time consuming and expensive to administer <hes> the process is the product as they they say <hes> but i think by taking steps to consider the quality and the consistency scale ability of the process of front by by using high quality g._n._p. Reagents from reputable suppliers <hes> by accurately predicting the amount of time and space materials tirias to process patients <hes> in and have consistent reproducible quality control parameters established early on. I think think <hes> cell therapy companies can improve the odds of gaining acceptance for the therapies and and reimbursement for their treatments. I'm sure there's other hurls. <hes> <hes> that that the industry is going to face but i see those as two significant ones that are gonna have to be overcome for for these therapies to have longterm success. Yes i agree on that and think that certainly there needs to be some good support for these companies to are have the materials that they need for moving these products to commercialization and that's why i was excited to see in september biotech knee launched a new initiative shift to create cell and gene therapy solutions to expedite the path from bench to clinic i wanted to ask why did you feel this was an important step. And what challenges do you plan to address with. This increased focus on workflow solutions for more than four decades the leader world leader in in the most trusted provider of <hes> immunoassays proteins antibodies small molecules for research use <hes> under the r._n._d. Systems brand talkers brand of reagents <hes> however we we probably were not quite as focused on the cell and gene therapy market <hes> to the extent. We probably should have been <hes> in recent years. We've made significant investments to <hes> produce reagents to the highest quality g._n._p. Standards <hes> and as you know we also acquired quad technologies <hes> to give us novel differentiated eventu- position in in self selection inactivation and we deployed our automated simple plex <hes> acid technology towards patient monitoring for adverse events like site a kind release syndrome and now we feel like we have a real critical mass and demonstrated competency in the in the clinical therapy self therapy space so we thought it was time for us to make a strong statement and and to let the world know that <hes> we were a player in contributor to this space <hes> with the same reliability we've demonstrated with our with our research agents in the past it yeah that makes a lot of sense and i know that biotechnology has acquired several cutting edge technologies in the therapy space sean. I'll ask you this this question. What do you believe are the most immediate workflow solutions that you can provide. Thanks for any so <hes> you know we have a lot of workflow workflow solutions we can provide but i'm gonna boil it down to really kinda four four different products that that we can immediately offer to the cell and gene therapy space <hes> the first being is is a technology that came from quad technologies <hes> we developed the a novel polymer <hes> that we put in a particle article format that we call clouds and what clouds does is it enables activation <hes> peaceful activation solution to activate and expand and <hes> t-cells for an atoglas or alginate <hes> adoptive t cell workflow such as carter tea cr the second and is technology from protein simple <hes> it's a automated elisa platform that we call ela that could be used for variety different applications <hes> <hes> including in process testing and potentially q._c. The third is is g._n._p. Small molecules so outside of just even the conventional not sell workflow a lot of really cutting edge. <hes> you know future therapeutics are p._s._e. Derived such as i._p._c. derived t. cells cells or cells or maybe even i guess he derived. I'm out of politics stem cells and some of the premier small molecules such as <hes> g._n._p. Cheer rock inhibitor and data for use within those workflows and we're really truly the only ones that offer <hes> g._n._p. Small molecules answer material in the space and lastly <hes> you know we're sticking to our guns given our expertise within <hes> protein manufacturing we offer you know a plethora of g._m. Piece cited kinds <hes> as well as other g._n._p. Proteins that's used within within within the cell culture step within cell and gene therapy so that would include cited kinds for t cell activation expansions such as conventional conventional. I'll to i'll seven fifteen but also ones that are for each ac- modified stem cells such as t. bo in the future <hes> s._e._f. The f and v again so there's a lot of versatility that we can bring to <hes> an immediate workflow solutions within the cell and gene therapy expes those are all great and it's it's wonderful. Those are available right now. I'm curious what <hes> new and innovative technologies are are the sun gene therapy team at techni working on for future and what workflow challenges to do those address sure <hes> and so within within even our product developments and within our the selling therapy unit we really take a a unit operation focused <hes> <hes> new new product development initiative what that means is as we know within cell therapy <hes> things are broken down within steps <hes> going from cell separation into cell culture to activation gene transfer and formulation and really we we we try to optimize build products within each respective you an operation and and and make them as much as most efficient as we can <hes> and so a luckily eating a little deeper into that one of the technologies that we developed that came over from quad is the clouds platform and so that's really solving is the ability to do t cell activation without the presence <hes> <hes> magnetic d platform so conventional technologies of us <hes> magnetic particles and have been a great product for research as wall as even some clinical program they've used today but there's some some challenges with respect to to that <hes> that technology and that being is that that you know one of those a magnetic bead and a residual magnetic bead is classified as a particular and there are literature sources that have demonstrated serrated that that there's a potential of adverse effect when you infuse these magnetic beats into a patient and so part of the current workflow regime so you have to remove move those magnetic beads downstream so that causes is a extra qualification steps. I mean you have to quantify the particles downstream but also you add <hes> another degree of of an operator manipulating the product and it adds a extra step. That's more time in a clean room and also adds more risk your therapeutic product so their address those challenges what we did is we kind of took the thesis of what would look like not selective asian without a magnetic bead and using our our palmer core competencies. We developed a palmer quick jail as i mentioned before which is desirable and we put it in a particle format to activate mimic <hes> an antigen presenting cell so you can call culture with a t cell to to drive a very similar stimulus that you would get with magnetic bead but you wouldn't have have to worry about those residual magnetic bead and those are central magnetic the carrier and so that's that's one innovative technology that that we've been developing <hes> for the cell and gene therapy space in addition outside of using clouds just for t cell activation expansion that seemed platforms gonna be parlayed into a cell separation platform in the future to enable a non magnetic cell separation workflow and again reducing the need to remove those magnetic beads reducing the questions on what happens if i carry those into therapy product and really enabling the space he's switching hats in terms of the protein side you know one of the big revelations that i've had recently within within the space and and we've been developing products for is how how process engineers and operators introduce exogenous cited kinds or proteins into to their culture vessel and so some of what we've been investing in is the ability to develop a unique protein delivery system. That's in a closed format how how they do it. Today is the actually take proteins and they have two zero dilutions biosafety cabinet which leaves you know your system fairly open and then bring it back into a culture vessel <hes> some of the things that we were working on and we'll be soon in the future to come to market is the ability to have a a closed system or well double format. They can weld your site akon cocktail to your culture bag allowing you to reduce operator error and and you know as essentially any sort of potential q._c. risks on. Maybe not adding the appropriate cocktail cited kinds for therapeutic product so this is something that we're solving within the cell and gene therapy business unit within by texting and hoping to offer <hes> to our customers within the space to help but they're worthless yeah we call this pro dots and <hes> we've had tremendous interest from customers and every time we present it we get a a ton of interest around our ability to deliver proteins in a closed system so as john points out that's certainly one of the most exciting things in differentiator. We think for for about techni <hes> in g._m._t. Cited kind space yeah <hes> and just a just a buildup of days common. It's it's amazing. How much of a challenge this is a simple. You know just just solving the problem. How you add a protein into your culture vessel. I mean it's it's actually a tremendous opportunity. <hes> and and current process engineers are really struggling with that with that simple that we're going to be solving yeah. It's interesting sometimes the what you perceive as being the most simple issue then turns out to be one of the largest this challenges in terms of of solving it so that that sounds really interesting and we'll be sure in the show notes to include links readers can go and look at these it products in more depth. I wanted to follow up on that. <hes> sean looking at the full biotech portfolio. I'm wondering during how can these products be used together to simplify workflows and i know you mentioned <hes> products but which solutions do you find most exciting and beneficial unofficial <hes> when you look at the full portfolio sure so just to give a little color on some of the initiatives on what we're doing with the portfolio folio by a technique products is really we're. We're coalescing a lot of products that we have within our portfolio under the selling therapy message. I mean we have a lot all the pieces of the workflow ranging from as i mentioned before to sell culture insulator materials too soon to be separation but also really important q._c. in process testing and so as a lot of q._c. and processing the engineers can appreciate is that in process testing is extremely important so if you're dealing with t cell activation your your primary t cells are secreting exogenous cited kinds in sumpter and you know depending on whether it's disease burden patient or depending on the indication you know it's it's it's difficult to track what those exogenous doing to your therapeutic product and so some of one of the things that i'm really excited about <hes> not only from the material side is is really how do you how do you test. Ask you know how that therapy product is doing and being manufactured as the process goes on and a lot of that is limited to <hes> just simple elisas and and allies are really challenging when you're doing on a manual front but some of the things that that were were really bridging is automated allies..

edge technologies editor mr david ensor dr shawn kev patient monitoring senior director president product development ela sumpter g._m._t palmer john four decades
"cell culture dish" Discussed on Cell Culture Dish Podcast

Cell Culture Dish Podcast

14:58 min | 1 year ago

"cell culture dish" Discussed on Cell Culture Dish Podcast

"Dish podcast a roadmap for efficient fed batch cell-culture optimization. I'm randy sergeant editor of the cell culture dish joining me. Today is dr andreas kazakhstan principal scientists at g._e. Healthcare life sciences dances dr custodian. He principal scientist for g._e. Healthcare's life sciences business in this role andrea address provides leadership and support the bioprocess business. His main area of expertise is in upstream processing prior to joining g healthcare. Undress was director of upstream upstream development at swedish orphan bio vitro a._b. Working with development of expression systems process development of microbial and mammalian.

dr andreas kazakhstan scientist principal director editor andrea