Clarity in cell line development

Clonal Derivation in Biopharmaceutical Cell Line Development – a Regulatory Perspective

19th November 2019: Early last month saw publication of the latest perspectives from the FDA in a paper entitled: Considering “clonality”: A regulatory perspective on the importance of the clonal derivation of mammalian cell banks in biopharmaceutical development authored by Joel Welch and Sarah Arden (USFDA). Key Points As a major supplier of technologies for …

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