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Designing the Stability Program

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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

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Abstract

Since therapeutic/functional activity and molecular/cellular structural changes can occur over time with biopharmaceutical products, stability data are necessary to establish a scientifically sound and appropriate shelf life. The goal of the stability program is threefold: (1) to determine what specific changes can occur to biopharmaceutical over time; (2) to try to determine the causality for the changes observed, using a root cause analysis, with the intent of understanding how to possibly minimize instability; and (3) to assess the impact of those changes on product quality and patient safety. In this chapter, the design of the biopharmaceutical stability program to achieve a proposed shelf life is 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). Designing the Stability Program. In: The Challenge of CMC Regulatory Compliance for Biopharmaceuticals . Springer, Cham. https://doi.org/10.1007/978-3-030-13754-0_12

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