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Demonstrating Product Comparability After Process Changes

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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

Abstract

Manufacturers need the freedom to make changes for improving their biopharmaceutical processes, not only during clinical development but also for continuous process improvement once in the marketplace. But along with this freedom to make manufacturing process changes comes the responsibility of carefully assessing the potential safety and efficacy impact on the biopharmaceutical product due to the changes being implemented. Demonstrating product comparability for a biopharmaceutical after a manufacturing process change is no easy task, whether it be for a recombinant protein or a genetically engineered cell. The three key elements of an effective comparability study will be examined: (1) the level of risk by type of process change, (2) stepwise reduction of residual risk, and (3) a risk-based effort by stage of clinical development. In this chapter, the difference between a comparability study and a comparability contract will be examined. Also, the challenge for biosimilar manufacturers in confirming biosimilarity will be 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). Demonstrating Product Comparability After Process Changes. In: The Challenge of CMC Regulatory Compliance for Biopharmaceuticals . Springer, Cham. https://doi.org/10.1007/978-3-030-13754-0_14

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