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Patient-centric Comparability Assessment of Biopharmaceuticals

Bluemel, Markus, Pohl, Thomas, Cordoba-Rodriguez, Ruth, Carroll, James, Beardsley, Richard, Maggio, Frank, Wylie, David, Tsang, Valerie, Ehrick, Robin, Francq, Bernard, Taktak, Sonia, Spasoff, Andy, Morrison, Amy, Albarghouti, Methal and Zhimei, Du (2024) Patient-centric Comparability Assessment of Biopharmaceuticals. Journal of pharmaceutical sciences.


The comparability assessment of a biological product after implementing a manufacturing process change should involve a risk-based approach. Process changes may occur at any stage of the product lifecycle: early development, clinical manufacture for pivotal trials, or post-approval. The risk of the change to impact product quality varies, and the design of the comparability assessment should be adapted accordingly.
A working group reviewed and consolidated industry approaches to assess comparability of traditional protein-based biological products during clinical development and post-approval. The insights compiled in this review article can be leveraged across the industry and encompass topics such as a risk-evaluation strategy, the design of comparability studies, definition of assessment criteria for comparability, holistic evaluation of data, and the regulatory submission strategy. These practices may help companies in design and execution of comparability assessments, and they may inform discussions with global regulators.

Item Type: Article
Keywords: Comparability Biologics Biopharmaceuticals Process change
Date Deposited: 12 Mar 2024 00:46
Last Modified: 12 Mar 2024 00:46


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