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

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