BioPhorum’s in-depth feedback includes 70 line-by-line, detailed comments, including the rationale for the points and any proposed changes/recommendations that are deemed necessary by the team to ensure a harmonized implementation across industry and regulatory agencies.
Cell line development
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Genetic characterization/ stability and regulatory aspects of cell line stability – Survey one
Oct 2021 | Benchmarking, Cell Line Development, Development Group
Survey examining the types of testing conducted and included in filing and research looking at companies’ approaches to setting and using acceptance criteria.
Genetic characterization/ stability and regulatory aspects of cell line stability – survey two
Oct 2021 | Benchmarking, Cell Line Development, Development Group
The second member only survey from the Cell Line Development workstream gathering information on the genetic characteristic and stability of cell lines.