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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Survey examining the types of testing conducted and included in filing and research looking at companies’ approaches to setting and using acceptance criteria.
The second member only survey from the Cell Line Development workstream gathering information on the genetic characteristic and stability of cell lines.