Potency Assay Guide


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Potency Assay Guide Cell and Gene Therapy

Included in the guide:

  • Potency Assay Introduction
    • Why it’s so important, and where to begin
  • Regulatory Requirements
    • A review of how the USP, ICH, and CBER guidelines define potency assay parameters
  • Steps to Validation
    • How to pursue your Target Assay Profile in a phase-appropriate manner
  • Challenges in Potency Assay Development
    • Adapting unique approaches for assay development and statistical design
  • Why use a CRO?
    • How to leverage scientific expertise and compliance-ready facility and procedures
  • Case Study
    • Review of potency assay development for a late stage AAV GT product

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