Advancing QC Testing for Cell and Gene Therapy Products
Ali Mohamed, Immatics (USA), Félix A. Montero Julian, bioMerieux (FRA), Dominic Wall, Cell Therapies Pty, Ltd (AUS)
The successful development and commercialization of Cell and Gene Therapy products opened a hope for patients with urgent medical needs and opened a door for a new era of modern medicine.
However, the manufacturing of C> products is very complex and they have to be released in a short timeframe. These are high value products, available in limited quantity that should be controlled employing complex set of tests in order to ensure identity, safety and potency.
The current microbiological compendial methods like sterility and mycoplasma testing are not adapted to these products. During this tutorial industry experts will address the QC Testing Strategies to Improve Manufacturing Turnaround Time, the bioMérieux Microbiology Testing Solutions to Increase Operational Efficiency and Improve Patient Safety and will discuss How to Make Rapid Testing Mainstream for ATMPs through a Question & Answer session.