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An Effective CMC Strategy is Possible

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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals and Other Biologics

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Abstract

The two forces that shape the corporate CMC regulatory compliance ­strategy for biologics—risk and resources—are examined. Also, in this chapter, the five core elements that comprise an effective corporate CMC regulatory compliance strategy for biologics—(1) embracing all CMC activities, (2) addressing unique requirements for specific biologic manufacturing processes, (3) addressing unique requirements for specific biologic products, (4) aligning the strategy to strategic ICH Q8/Q9/Q10/Q11 guidances, and (5) ensuring that the CMC activities meet the minimum requirements of cGMPs—are discussed in detail. Finally, the central role of a clinical phase-appropriate approach to the CMC regulatory compliance strategy for biologics is described.

Coming together is a beginning; keeping together is progress; working together is success.

Henry Ford, American businessman, 1863–1947

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Authors and Affiliations

  1. BioPharmaceutical Quality Solutions, Carlsbad, CA, USA

    John Geigert

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  1. John Geigert
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Geigert, J. (2013). An Effective CMC Strategy is Possible. 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_3

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