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Complex Process-Related Impurity Profiles

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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

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Abstract

The safety risk of process-related impurities needs to be assessed for both chemical drugs and biopharmaceuticals. It will be shown, that compared to chemical drugs, biopharmaceuticals (whether recombinant proteins, monoclonal antibodies, genetically engineered viruses or genetically engineered cells) have a much more complex process-related impurity safety profile, especially due to the living system-related impurities. The importance of applying a risk-based approach in order to effectively control process-related impurities in a biopharmaceutical is stressed. The challenge that biosimilar manufacturers have in comparing their impurity profiles to that of an innovator’s biopharmaceutical is also discussed.

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  1. BioPharmaceutical Quality Solutions, Carlsbad, CA, USA

    John Geigert

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Geigert, J. (2019). Complex Process-Related Impurity Profiles. In: The Challenge of CMC Regulatory Compliance for Biopharmaceuticals . Springer, Cham. https://doi.org/10.1007/978-3-030-13754-0_8

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