The forum "Analytical Methods" on Tuesday, September 28, 2021 will focus on the validation, implementation and transfer of analytical methods as strategic steps for the development, production, product release and monitoring of production processes.
Luc-Alain Savoy, Global Head of Biologics at SGS, will be presenting "Biologics characterisation, from R&D to QC release" at 10:15.
During his presentation, he will explore Biologics – large and complex structures manufactured in living cells or organisms. Their in-depth characterisation is essential for regulatory acceptance but particularly difficult because they are composed of several molecular entities more commonly referred to variants.
A review of the methods used for the physico-chemical characterisation will be presented and segregated in two categories – the methods used to increase the knowledge and understanding of the product and it’s structure/function relationship and, derived from this group, the methods used for batch release and stability assessment.
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