Potency assay development for advanced therapy medicinal products

Potency testing for advanced therapy medicinal products (ATMPs) is both a Current Good Manufacturing Practice (cGMP) requirement and a challenge. Often the mechanism of action (MoA) is very complex and may not be fully understood or the reflection with in vivo fate is difficult to demonstrate.

By taking a matrix approach, various aspects of product characteristics can be assessed. Transcriptional, translational, and functional levels can be covered, and, various potential MoAs can also be addressed.

In this SelectScience webinar, Dr. Sascha Karassek, R&D Scientist at Charles River Laboratories Germany GmbH, will share top tips for overcoming the challenges of designing a potency assay development strategy for ATMPs. Brief case studies on bioactivity determination for ATMPs using the matrix approach will also be presented.

Key topics discussed in this webinar will include:

• Understand the requirements for cell-based relative potency assays
• Learn how to take the matrix approach for ATMPs
• Gain tips to overcome challenges associated with potency testing of ATMPs

Who should attend?

• Scientists working with cell-based potency assays related to ATMPs or CGTs
• QA/QC professionals working in a GMP environment

Certificate of attendance
All webinar participants can request a certificate of attendance, including a learning outcomes summary, for continuing education purposes.