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Source Materials for Biologics

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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals and Other Biologics

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Abstract

The significant differences between source materials for chemical drugs and biologics are evaluated. Furthermore, the CMC regulatory compliance requirements for each type of biologic source material—cell banks, virus seed banks, and transgenic seed/animal banks—are thoroughly discussed in this chapter. Finally, four myths about biologic cell banks are debunked: (1) must have both a Master Cell Bank and a Working Cell Bank, (2) a phase 1 clinical stage Master Cell Bank is perfectly acceptable for commercial use, (3) multiple Master Cell Banks during clinical development are not a major risk, and (4) Working Cell Banks rarely cause problems.

Breakthrough technologies deserve a breakthrough in the way the FDA evaluates them.

Andrew von Eschenbach, Former FDA Commissioner, in a February 2012 Wall Street Journal opinion article

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  1. BioPharmaceutical Quality Solutions, Carlsbad, CA, USA

    John Geigert

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Geigert, J. (2013). Source Materials for Biologics. In: The Challenge of CMC Regulatory Compliance for Biopharmaceuticals and Other Biologics. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-6916-2_5

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