Symcel will exhibit and present at the 2025 PharmaLab congress, taking place November 24–26 in Düsseldorf/Neuss, Germany.
The conference addresses developments in modern pharmaceutical and biopharmaceutical laboratories. Visit us at Stand 15 to learn about the latest advances in rapid, phenotypic microbial detection.
On Tuesday, 25 November, in the Alternative and Rapid Microbial Methods session, Dr. Wilhelm Paulander, Chief Clinical Development Officer, and Dr. Nore Struyf, J&J Innovative Medicine – Analytical Development Microbiology, will give two presentations on the latest developments and validation of the calScreener+ biocalorimeter system.
Rapid, Phenotypic Sterility Testing for Cell and Gene Therapy Products: Validation of a Three-Day Protocol Using the calScreener+ Platform
Dr. Wilhelm Paulander, Symcel
Introduction to the calScreener+ platform
Presentation of validation data for a commercial phenotypic sterility testing system based on isothermal microcalorimetry
Direct inoculation into complex CGT matrices
Detection limits, speed and specificity
Detection limit and specificity for 30 Ph. Eur. and USP-relevant species and other microorganisms, non-inferiority analysis based on parallel tests according to Ph. Eur. 2.6.1 and USP <71>
Application in CGTP manufacturing processes
Moving the Needle for Sterility Testing: Towards a New, Rapid Sterility Test to Allow Faster Release of CAR-T Drug Products
Dr. Nore Struyf, Johnson & Johnson
Vein-to-vein (V2V) time in cell therapy must be minimized
A rapid sterility test with <3-day turnaround is essential
Biocalorimetry-based technology identified as a promising rapid method
Initial results show detection of various microorganisms within 3 days at high and low spike levels
Full GMP validation and comparability study planned to support routine use
Learn more & get in touch
Read more about rapid sterility testing of cell and gene therapy products.
See full conference scheduele on the PharmaLab congress website.
Contact us to schedule a meeting during the event.