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Biopharmaceuticals Are Not Chemical Drugs

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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

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Abstract

Biopharmaceuticals are definitely different from chemical drugs. This is not a perception, but a reality, and it is reflected by the statements on regulatory authority websites and in the wording of the regulatory guidances that they issue. Also, as is shown in this chapter, the four major CMC differences between biopharmaceuticals and chemical drugs are discussed: (1) how the products are synthesized, (2) impact of the process on the manufactured product, (3) complexity of the manufactured product, and (4) biosimilars are not bio-generics.

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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. (2019). Biopharmaceuticals Are Not Chemical Drugs. In: The Challenge of CMC Regulatory Compliance for Biopharmaceuticals . Springer, Cham. https://doi.org/10.1007/978-3-030-13754-0_2

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