Mingyu Oh, Assistant Manager, Celltrion
Recently, in the pharmaceutical/bio industry, especially in the CMC field, there are increasing cases where each regulatory agency (FDA, EMA) recommends the application of statistical methodologies for product equivalence or quality evaluation, and naturally, the academic community Research is also ongoing.
Celltrion is researching statistical methodologies in various fields to respond flexibly to the recommendations of regulatory agencies. One, simulation-based comparability evaluation is implemented in JSL, and additionally, in the purification process development stage that removes viruses and foreign substances to extract pure protein, the analysis for screening items that affect actual quality is done in JSL. Let me introduce you to the process of automation.
