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Biopharmaceutical Source Materials

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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

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Abstract

The source material for a biopharmaceutical contains the genetic capability of producing the biopharmaceutical product. The main focus of this chapter is on the source materials for manufacturing (1) the recombinant proteins and monoclonal antibodies (i.e., cell banks), and (2) the genetically engineered viruses used in gene therapy (i.e., cell banks, virus banks, plasmid vectors). Also, in this chapter, three myths about the recombinant cell banks are debunked: (1) a Master Cell Bank used to manufacture an early stage clinical development biopharmaceutical is perfectly acceptable for use in commercial manufacture of that biopharmaceutical, (2) exchanging out a Master Cell Bank during clinical development is not a major risk, and (3) a Working Cell Bank never causes manufacturing problems.

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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). Biopharmaceutical Source Materials. In: The Challenge of CMC Regulatory Compliance for Biopharmaceuticals . Springer, Cham. https://doi.org/10.1007/978-3-030-13754-0_5

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