Challenging Standards for Genetic Characterization of Manufacturing Cell Lines

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Genetic characterization of mammalian cell lines prior to registrational filing is a regulatory requirement documented for example in ICH Q5D. It is required to demonstrate that a cell line is genetically stable throughout the manufacturing process to ensure manufacture of a consistent product. Several different approaches for genetic characterization of cell lines are common in the industry. Firms perform assays internally, or outsource testing to Contract Testing Laboratories. External testing is mostly performed using GMP test methods; for internal testing, there is about an equal split between use of GMP and non-GMP methods. In this presentation, I’d like to challenge the need of GMP test methods for genetic characterization of cell lines.

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Vie 14 de Noviembre de 2025

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Descripción

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Sáb 15 de Noviembre de 2025

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