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Business & Regulation Analytical Science, Standards & Regulation

Banking for Bioassays

As technology advances, regulators are demanding ever-greater precision, accuracy and reproducibility of assays used during pharmaceutical development. The goal is clear: to ensure that the products ultimately delivered to patients are of high quality. Bioassays are an important component in ensuring regulatory compliance, and effective bioassays require reproducible cell lines; analytical bioassay cell banks are commonly used to provide the necessary cells.

There is a large amount of guidance – both regulations and standards – governing the production of GMP production cell banks, notably the ICH document Q5D on the derivation and characterization of cell substrates used for production of biotechnological and biological products (1). These will be serially sub-cultivated cells that are characterized by common starting sources for each production lot; in other words, they are preserved banks of cells. The guidance states that the identity, purity and stability of the parental cell line, and subsequent master and working cell banks, must be confirmed.

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About the Author

Mike Merges and Mike Sadick

Mike Merges is Director of Strategic Growth of Biologics Analytical Services, and Mike Sadick is Principal Scientist, Biologics Analytical Services, both at Catalent.

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