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Assurance, Validation and Verification in Clonality

Duncan Borthwick PhD This document represents the opinions of Solentim Ltd and should not be used in place of regulations or published guidance from the USFDA or any other regulatory body Within the cell line development community there is a widely accepted regulatory expectation to demonstrate that a Master Cell Bank (MCB) has been derived …

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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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Proof of clonality and its importance in stable cell line development

What is clonality and why is it important Clonality is a crucial step in stable cell line development (CLD) for biotherapeutic workflows and one closely monitored by the medicines’ regulators. Their questions lead to two possible conclusions about how they view the importance of clonality1: Assurance of “clonality” of stable production cell lines is of …

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