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Quality Attributes of a Biopharmaceutical

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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

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Abstract

A biopharmaceutical (whether recombinant protein, monoclonal antibody, genetically engineered virus or genetically engineered cell) is defined by its quality attributes. These attributes can be physical, molecular, cellular, immunochemical, microbiological and/or biological properties or characteristics. In this chapter, seven major categories of quality attributes for all biopharmaceuticals that need to be tested are examined – appearance/description, identity, purity/impurities, potency, quantity, adventitious agent safety, and general. Specific testing to meet the requirements of each of these quality attributes for each biopharmaceutical type is discussed.

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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). Quality Attributes of a Biopharmaceutical. In: The Challenge of CMC Regulatory Compliance for Biopharmaceuticals . Springer, Cham. https://doi.org/10.1007/978-3-030-13754-0_11

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