E-BOOK: Potency Assay Guide, 3rd Edition

Download the Potency Assay Guide to get expert insight on guidance and considerations.

Included in the guide:

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

Request your copy today!