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Complex Process-Related Impurities

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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals and Other Biologics

Abstract

The difference in how the safety risk of process-related impurities is assessed between chemical drugs (which have a regulatory road map) and biologics (where a case-by-case basis is applied) will be examined. It will be shown that compared to chemical drugs, biologics have a more complex process-related impurity safety profile, especially due to the living system-related impurities. Finally, in this chapter, the importance of applying a Quality Risk Management (QRM) approach in order to effectively control process-related impurities in a biologic is stressed. Examples from cell culture processes, transgenic animal/plant processes, virus processes (both viral vaccines and gene therapy vectors), and cell-based medicinal processes are provided. The challenge for biosimilar manufacturers in comparing their impurity profiles to that of the hidden innovator’s biologic is also discussed.

Not everything that can be counted counts,

and not everything that counts can be counted.

Albert Einstein, Nobel laureate physics, 1879–1955

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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. (2013). Complex Process-Related Impurities. In: The Challenge of CMC Regulatory Compliance for Biopharmaceuticals and Other Biologics. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-6916-2_8

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