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.
Speakers
Dr. Sascha Karassek joined Charles River Laboratories in 2018. He is currently a scientist in the Bioassay Research & Development team in Erkrath, Germany. He gained a PhD in Biochemistry at the Ruhr University Bochum, Germany, and worked for nearly four years as a Post-Doc at the Center for Molecular Biology of Inflammation and for three years as Principal Scientist in the Oncology and Immunology department of WuXi AppTec, Shanghai, China. He is an expert in mechanism of action-reflecting bioassays for protein therapeutics as well as for advanced therapy medicinal products.
Moderator
