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Sterility Assurance-Current and Future State.

Edward C Tidswell1, James P Agalloco2, Radha Tirumalai3

  • 1Merck, West Point, PA 19486; edward.tidswell@merck.com.

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|September 17, 2021
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Summary
This summary is machine-generated.

Sterility assurance for therapeutics is evolving beyond traditional compendial testing. New United States Pharmacopeia (USP) chapters pave the way for parametric release, optimizing sterility assurance for advanced therapies.

Keywords:
Design spaceMicrobial controlParametric releaseSterile manufactureSterilitySterility assurance

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Area of Science:

  • Pharmaceutical Manufacturing and Quality Control
  • Microbiology and Sterility Assurance
  • Regulatory Science

Background:

  • Traditional aseptic processing with end-product sterility testing dominates therapeutic manufacturing.
  • Despite advances in science and technology, sterility assurance standards and regulations have lagged.
  • Current sterility assurance approaches are not optimally serving diverse and advanced therapies.

Purpose of the Study:

  • To propose a new direction and roadmap for the future of sterility assurance.
  • To explore how revised United States Pharmacopeia (USP) chapters <1211> and <1222> can enhance sterility assurance.
  • To advocate for parametric release as the default disposition for therapies within an optimized design space.

Main Methods:

  • Analysis of current sterility assurance practices and regulatory landscapes.
  • Examination of recent advancements in therapeutic products, such as chimeric antigen receptor T-cell therapies (CART).
  • Review of proposed changes and implications of revised USP informational chapters.

Main Results:

  • Parametric release is identified as the default and expected mode of disposition for many current and future therapies.
  • Chimeric antigen receptor T-cell therapies (CART) already align with principles of parametric release.
  • Revised USP chapters <1211> and <1222> offer a framework for an optimized sterility assurance design space.

Conclusions:

  • A paradigm shift towards parametric release, supported by updated USP guidelines, is necessary for modern therapeutics.
  • The proposed roadmap facilitates optimal sterility assurance and expands opportunities for parametric release.
  • This evolution ensures robust sterility assurance for both current and novel therapeutic modalities.