The Potency Assay Guide, Edition II

The Second Edition of The Potency Assay Guide will be available early 2020. Pre-order your copy today!

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>
  • Even More Case Study
    • Review of potency assay development for a late stage AAV GT product

Pre-order your copy today:
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