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Manufacturing of the Drug Product

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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

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Abstract

The CMC regulatory compliance impact of the manufacture of the biopharmaceutical drug product due to the choice of formulation composition, coupled with the choice of the product-compatible container closure system, is examined. Also, the various manufacturing processes to conjugate a protein to a chemical (e.g., PEGylation) or to a drug (e.g., ADC) prior to formulation is discussed. The criticality of carrying out the filling and sealing process of the drug product under GMP aseptic conditions to obtain sterile injectable biopharmaceutical drug products is presented.

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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). Manufacturing of the Drug Product. In: The Challenge of CMC Regulatory Compliance for Biopharmaceuticals . Springer, Cham. https://doi.org/10.1007/978-3-030-13754-0_7

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