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:
Please complete the form below to place your order: