Potency assay development for advanced therapy medicinal products

May 21, 2025 - 16:00 BST / 17:00 CEST / 11:00 EDT / 08:00 PDT

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 learning objectives:

• 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.

If you view the on-demand webinar, you can request a certificate of attendance by emailing editor@selectscience.net.