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Session Details

bioMérieux Presentation: Fully Automated One-Hour Mycoplasma Testing for Products Containing Mammalian Cells Using a Molecular Lab-In-a-Pouch Closed System
Friday, May 31, 2024 10:30 AM - 10:45 AM  
Exhibit Hall - Theatre B
Global Showcase Presentation
Presenter
  • Félix A. Montero Julian, PhD, Senior Scientific Director, bioMérieux, FRANCE
     
Testing for Mycoplasma contamination is a required release test for Cell & Gene Therapy products (CGT). Compendial methods require 28 days of testing and are not suitable for short shelf-life products. Moreover, CGT product sample availability for carrying out the test is also a limiting factor to be considered.

Learn how the BIOFIRE® Mycoplasma test’s simple 3-step workflow requires no expertise and can be performed by anyone, anywhere, at any time. The closed “molecular lab in a pouch” system ensures data integrity with just 2 minutes of hands-on time and no result interpretation. A new pre-processing protocol will be presented which requires minimum sample volume and allows the inclusion of mammalian cells. It thereby answers the unique needs of CGT manufacturers for a fast & easy Mycoplasma release test.

Session Objectives:
• Safety quality attributes for Cell and Gene therapies
• New technology for automated mycoplasma detection in cell therapy products
• In-process and product release testing

SPONSORED BY:
Felix MONTERO JULIAN
Senior Scientific Director
bioMérieux
Speaker