How to define acceptable changes for QA’s of antibodies

In Antibodies, Drug Safety by charlottebLeave a Comment

antibodies, QA, Sandoz, qualityattributes

 

Do you need to ensure that your antibodies are manufactured to a consistent product quality, and therefore guarantee a reproducible clinical performance and acceptable safety profile?

Dr Martin Schiestl, Scientific and Regulatory Advisor at Sandoz contributed to the debate about acceptable changes in quality attributes and how to identify them, when he spoke at the European Antibody Congress 2011. Dr Schiestl delivered three case studies where he evaluated the structure variation of 3 of Sandoz's major marketed biologics: Aranesp (R), Rituxan (R)/ Mabthera(R) and Enbrel(R).

Click here for the full presentation

 

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