7 Burst results for "Brandy Sergeant"

"brandy sergeant" Discussed on Cell Culture Dish Podcast

Cell Culture Dish Podcast

05:43 min | 2 weeks ago

"brandy sergeant" Discussed on Cell Culture Dish Podcast

"Welcome everyone I'm brandy sergeant with the sultry dish today I'm joined by Ken Chen. Senior Director and head. Belushi. Regulatory. Affairs unit KEN has over seventeen years experience in the bio therapeutics industry with a little over five of those while at UC biologics and another ten years with burying CMC and quality duties at Amgen. Welcome. Ken. Thank you. Randy for having. Can recently it was brought to my attention that she biologics is publishing on a quarterly basis a summary of regulatory our new. Or revised guidance documents from the various global regulatory agencies. I perused your various updates on your company's website and I found this to be a valuable resource for anybody in the biological drug development arena looking to stay current on continuous and bass number of updates, documents from all the agencies what prompted you to undertake such an effort and to create these updates in the first place. We work with companies from around the globe in all facet of product discovery development and GM MANUFACTURING Across, the food drug development continuum from preclinical commercialization. Due to the nature of the services we provide we need to provide an optimal regulatory CMC strategy maintaining a very high quality standard and adhere to current. GNP's does we ming up to date with developing global regulatory expectations. We want to be proactive to minimize regulatory risk by densify regulatory changes or new hurdles in the bands and so if needed, we would rapidly was on to perform. Gab. In. Formula. Strong risk mitigation strategy. Makes Sense so it appears having these updates is a win win for both you and your clients. Absolutely, Brandy keep in mind the companies working with US filing. At Bailey's in various addictions and we virus outs in documentation that will be a part of those filings. Does we too need to adhere to the quality and GM is standards require in does various geographic than us? Since. We are such a large organization because we provide a one stop single source development platform and such a wide array of services. It became imperative that we developed internally Americanism to keep our entire staff up to date with developing wiring and rapidly evolving regulatory agencies, updates, and expectations. So you fell to my team to assimilate and disseminate this. In wishy biologics. I was wondering I. The resources out there already that can help with this. Yes. We actually used some of them to help put out updates together but many are not organized by eight thirty in topic and a not as why ranging from a global perspective as what we felt like we had to put together.

GM Ken Chen Randy UC biologics US Ken KEN Belushi Senior Director Amgen Brandy Bailey
"brandy sergeant" Discussed on Cell Culture Dish Podcast

Cell Culture Dish Podcast

04:30 min | 3 months ago

"brandy sergeant" 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
"brandy sergeant" Discussed on Cell Culture Dish Podcast

Cell Culture Dish Podcast

09:16 min | 5 months ago

"brandy sergeant" 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 | 5 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
"brandy sergeant" Discussed on Cell Culture Dish Podcast

Cell Culture Dish Podcast

07:32 min | 10 months ago

"brandy sergeant" Discussed on Cell Culture Dish Podcast

"Therapy. Analytics is permit monitoring of critical quality attributes and increased manufacturing efficiency. I'm Brandy Sergeant at Tradit- joining me. Today is Jonathan Royce. This director of the instruments business unit for Nova. Jonathan has twenty years of experience in life sciences industry and has worked with process process and product development scale up and process modelling. Jonathan holds degrees in chemical engineering from northeastern university. And the University of New Hampshire Shaw. I wanted to start today by asking if you could describe some of the manufacturing challenges facing the gene therapy industry today absolutely well. There's definitely a capacity crunch for manufacturing of gene therapy doctors so firstly one can say that. There's a challenge just to figure out where one should manufacture picture But once that problem is there are lots of questions remaining about how today there are no template processes for vectors so the process development activities are quite quite intense compared to more establish therapeutics like antibodies. Furthermore there are no established packages of analytical techniques so while one development team is working on establishing the process oftentimes another team is working on establishing the analytical characterization leading sometimes to cases instead of like chicken and egg scenario where the process development team is waiting for an analytical method a local methodist also waiting for results from the process development team that makes sense and then to follow on with that. Why is scale up of the gene therapies particularly difficult? But I don't know if it's inherently more difficult than other biologics but it certainly is less mature Historically viral vectors are produced using adherent cell lines with transient transaction at this epic production doesn't undersell well to scale up although it could possibly be scaled out But that's it. There are plenty of examples where viral vectors have been produced in suspension cell systems. So it's a doubtedly only a matter of time before we have really scalable production systems and to go back to the analytics piece. You mentioned the analytics is a critically important. And that rings true for Bio Manufacturing and gene therapy as well. Could you describe the analytics are currently being used for gene therapy manufacturing to monitor critical quality parameters sure today the analytics packages being used to characterize gene therapy. Vectors are a combination the nation of techniques including dynamic light scattering analytical ultra-centrifugation can VCR surf respond to residents and electron microscopy. It's it's important to have these or orthogonal techniques to measure different parameters with some degree of overlap this helps us to ensure that we get compete characterization relation but it also provides a little redundancy that's necessary to have reliable results to go back to dynamic light scattering. It's a technique frequently gently used to determine particle size distribution and to detect aggregates culture. But what are the limitations to this technique deal. US is a great technique in in that it has broad applicability and it provides very quick results it's however limited by the fact that it is a low resolution method that cannot Often resolve all entities. which are similar in size? And well the Alaskan detect particles over a really broad of size range the size of the particles were typically trying to characterize in gene therapy. Applications are often in the lower one percent of that range. This means that the resolution of the particles of interest and smaller contaminants for example that can become very challenging own Djing using DOS and gene therapy applications and I know that Var Nova has developed the mini tempt to improve gene therapy in licks. Could could you describe how it works for listeners. Yes sure I'd be happy to Many times a compact transmission electron microscope. That sees controlled by an integrated software. Package I package automates. Many of the steps that microscopy normally need to do manually. The process of analyzing sample is done in three steps. So I you need three micro liters of sample. Those three Michael leaders are prepared by fixing the simple on a copper Mesh Grid. Then the grid is inserted into the microscope in a series series of images are taken and this can be done either manually or using the automation built into the software and then finally images are processed using image analysis algorithms. What's that detect and classified the different particle types that we observe in the sample and this way the image data is actually translated into quantitative data? That can be used used in analyses like productivity charity or aggregate analysis. It's really interesting. I I saw a recent INFO graphic on gene therapy that Viren Veyron over published and it showed that the mini tem can be implemented to reduce development time. Could you explain for listeners. How the process streamline with the mini temp because I thought that was really Important for for listeners to know and also the info graphic all place it in the show notes so that listeners will be able to go back to it in view the info graphic back. Okay Great Yeah. I mean absolutely I can explain that point you know. Process Development is a tough job where scientists are given relatively little time to make key decisions on what amounted to us Also what conditions to maintain and what measure and in order to make good decisions you. Scientists need high quality information and they need this information to be available almost immediately And minicam really enables just by putting the power of electron microscopy and the PD or analytical lab lab previously discussed. There were lots of complementary methods in the market but many times perhaps the only method that provides direct visual confirmation of. What's going on in your sample? And we've seen time and time again. This visual information provides insights that other analytical methods missed and getting those insights early say weeks or even months of time so that informed informed decisions can be made quickly think that's really beneficial information And also in the same info-graphic you explain how many Tim can increase the number of projects. That could be run simultaneously. Could you elaborate on that a little bit as well. Yeah of course We often talk about shorten Korten development time as being critical to getting products on the market faster and this is of course one very important aspect but the reality is that PD is one of the main bottlenecks in the development. I'm into new. Therapeutics and PD teams always have more projects in the pipeline than they have capacity for so shorting development cycle for a single project also increases the deficiency of it given team scientists. meaning that they can make them more productive and deliver more projects in the same period of time. That's great because everybody needs more time always for their work and especially in labs. That are busy like that. It's the more hands on. You can get projects better. I wanted to thank you so much for this. I think it's really interesting interesting. A No gene therapy is a developing area in manufacturing is developing as well right along with the industry So this has been really helpful and interesting to learn more about Improved analytics For this industry would you be able to add anything else for listeners. Today that we may have missed talking about. I think I just like to add that you know. We have over immensely proud to be part of this exciting field of gene itself therapy It feels really meaningful to see that therapeutic market is moving from treatment treatment to cure.

Jonathan Royce development team University of New Hampshire product development Brandy Sergeant director US Bio Manufacturing Tradit Var Nova Michael Tim
"brandy sergeant" Discussed on Cell Culture Dish Podcast

Cell Culture Dish Podcast

07:17 min | 1 year ago

"brandy sergeant" Discussed on Cell Culture Dish Podcast

"I'm brandy sergeant editor of the so-called tradit- joining me today's kimberly wiklund kimberly is the head of product with management for the inca site at sartorius. Kim joined the inky site team in two thousand fifteen and has worked in the world imaging and microscopy since two thousand she obtained her p._h._d. In chemical engineering from the university of california berkeley and currently lives in ann arbor michigan <music> sell modeling in cell systems have evolved significantly. Can you explain for listeners. How cell monitoring has advanced to meet. These needs absolutely <music>. <hes> researchers now are really on a quest for physiological relevance and their cell models and their cell system without that physiological relevance in the past two significant advances that are going to translate from bench to bedside. There's gonna be a lot of disappointment but out out that relatives <hes> those disappointments costs a lot of money so now researchers are making a shift from very simple recombinant governance systems and they're moving towards these primary cells or stem cells are cells. Those cells are often human and they're often patient specific. There are a lot of co cultures multi-culture issue oregon state models all of these things offer significant promise but they do present challenges to the typical workflows what we're seeing in the fundamental shift in cell models and that fundamental shift is moving towards this complexity sensitivity and scarcity. Your typical immortalized cell lying survive. If you lost a flask say in your laboratory in the hood so the day maybe the night those cells could still survive but experience with advanced cell models require very very precise environments and and also an increase in efficiency in a reduction in failures because at the end of the day no cell can be wasted did in this new world of so models and because of this. There's a big pressure on the instrumentation. How can we ensure instrument is is designed for the cells and not the other way round. We often see systems for analysing cells that arise avenue technological article discovery and then the cells kind of get shoehorned in to that technology. We do things like fixing ourselves. We kill them. We use many of them <hes> in order to get a measurement but really that's not the way to go with these new cell models. Now we need systems that reliably measure small numbers. There's a south that are in a stable. The a logical environment and the cells need to stay that way throughout the entire observation and measurement process many of these cell types. Don't wanna be jostled around on a piece of equipment or hold back and forth from the incubator to the equipment so instead instead of starting with the focus on the system -nology we need to imagine the solid and they're happy place and designed to keep them that way and we really need to see them on their journey. There are many complex interactions with these new types of models and we have to look at them over time and then really the last thing we have to think of the cells first formal status for certain but we have to think of the users of these cell models as well. That is a very symbiotic relationship. If the scientists can't get their work done efficiently then their souls aren't being used efficiently cells. We're sitting in on an instrument in an uncontrolled environment while the users trying to figure out how to use instrument then instrument is doing a disservice. I i really am interested in a live cell analysis and i'm wondering if you could tell us how live cell analysis works and how it's different from input workflows such pitches flipside thomas for example very simply put lifestyle analysis centers on the dimension of time and it centers was on repeated measurements of the same populations of cells so if you think about say your favorite sport you wanna see the score halfway through and see nothing else or you wanna watch how it evolved if you only see the score at a point in time. How do you know who won. How do you know would you feel about the next game. We really have no idea what to calm. I really liked that analogy. I think that's a great one. Can you tell us a little bit more about why life i saw. Malices is a good fit for advanced cell systems like primary cells and stem derived cells yeah definitely i will take the sports analogy a little bit further <hes> if you're watching a game you really wanna know what team started strong. Maybe lost her edge. What players it's a really shining and all of that can change in an instant so think of your cell. Model is your favorite team. They're full of different personalities personalities that can be considered unpredictable until you wash them long enough until you really dig in and put them in an environment that doesn't change which then only then. Can you begin to predict how they're going to behave that makes a lotta sense and to dig more deeply into this. Can you describe the inky site lifestyle analysis technology and then why it is a good fit for these more advanced cell models wakened can mentioned earlier you have to start by being an advocate for the cell and for the scientists with inky site we think about the south and we put them in a precise robust environment. Which is your standard tissue culture incubator then we leave them. They're absolutely absolutely perfectly still the cell stay put they do their thing and the inky site has a mobile optical system that travels to the cells and captures images repeatedly in an automated fashion over time and then for the scientists we make it simple and as automated as possible to get from the time that you put the cells in achey site to the time when you're standing in front of a group because any results we're making graphs for publication when we are doing product development we have a team of biologists are sitting right alongside the engineer saying hey i need this to be fewer clicks or i need this to be better suited to my workflow or you know. I don't want to figure that out. That's more technology than biology breath and that's the rule if it gets too complicated and we're wasting cells were wasting scientists time and we just don't like to do that. I think that's a great model for the end users experience and matching that with your engineers. I think it works makes for a great partnership. You have of an exciting.

inky engineer university of california berke oregon Kim editor ann arbor michigan head of product achey Malices product development
"brandy sergeant" Discussed on Cell Culture Dish Podcast

Cell Culture Dish Podcast

14:41 min | 1 year ago

"brandy sergeant" 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