Title: Potency assay development for advanced therapy medicinal products
Speaker: Dr. Sascha Karassek (Charles River Laboratories)
Language: English (with English subtitles)
*You can watch the webinar from anywhere with an internet connection.
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 webinar, Dr. Sascha Karassek, R&D Scientist at Charles River Laboratories Germany GmbH, shares 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 watch?
- Scientists working with cell-based potency assays related to ATMPs or CGTs
- QA/QC professionals working in a GMP environment
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