Recently, in the pharmaceutical/bio industry, especially in the CMC field, there are many cases where regulatory agencies (FDA, EMA) recommend applying statistical methodology for product equivalence assessment or quality assessment, and naturally, research on this is also continuously being conducted in academia.
Celltrion is also studying statistical methodology in various ways to flexibly respond to the recommendations of regulatory agencies. In this presentation, we will implement the simulation-based comparability evaluation with JSL, which was introduced by Professor Burdick, a statistics professor and JMP/SAS Instructor, in the webinar (Statistical Methods for CMC Comparability Studies). In addition, we will introduce the process of automating the analysis with JSL for the primary screening of items that actually affect the quality in the purification process development stage to extract pure proteins by removing viruses and foreign substances.
