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Priceless Potency (Therapeutic Activity)

  • John Geigert
Chapter

Abstract

The complexity of biopharmaceuticals can present significant challenges to establishing potency. In this chapter, the three types of functional activity assays for measuring potency of biopharmaceuticals will be examined: bioassay, surrogate assay, and assay matrix. In addition, it will be shown that the development, optimization, and validation of these potency assays can be implemented by a risk-based approach during clinical development. Finally, it will be stressed that most manufacturers underestimate the amount of resources and time needed to properly implement these potency assays for recombinant proteins, monoclonal antibodies, genetically engineered viruses and cells.

Keywords

Strength potency Therapeutic activity Biological activity Functional activity Bioassay Surrogate assay Assay matrix 

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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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