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Designing the Stability Program

  • John Geigert
Chapter

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.

Keywords

Stability protocols Real conditions Accelerated conditions Stress (forced degradation) conditions Extrapolation Expiry date Shelf life 

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Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  • John Geigert
    • 1
  1. 1.BioPharmaceutical Quality SolutionsCarlsbadUSA

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