E-BOOK: Potency Assay Guide, 2nd Edition

This booklet was written by Absorption Systems experts. It is our hope that you will benefit from the information, guidance, and considerations it contains.

 

 

 

 

 

 

Included in the guide:

  • Potency Assay Introduction
    • Why itโ€™s so important, and where to begin
  • Roadmap ofย 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!

READY TO PROGRESS YOUR POTENCY ASSAY PROGRAM?