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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals and Other Biologics pp 1–20Cite as

Complexity of Biologic CMC Regulation

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Abstract

The complexity of biologic regulation both within the United States and the European Union is unveiled. As shown in this chapter, the multiple pathways for regulatory approval can appear confusing for biologics and place pressure on the regulatory affairs group within a company, especially in explaining to those in their company why a biologic is treated under one pathway and not another.

Targeted biologics is one of the most exciting areas of therapeutic medicine and may represent about one in every four newly commercialized drugs in the future.

Published BlissHealth biopharm industry survey, August 2011

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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). Complexity of Biologic CMC Regulation. 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_1

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