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Complexity of Biologics CMC Regulation

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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

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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 biopharmaceuticals 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.

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  1. BioPharmaceutical Quality Solutions, Carlsbad, CA, USA

    John Geigert

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  1. John Geigert
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Geigert, J. (2019). Complexity of Biologics CMC Regulation. In: The Challenge of CMC Regulatory Compliance for Biopharmaceuticals . Springer, Cham. https://doi.org/10.1007/978-3-030-13754-0_1

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