Cell Therapy Sterility Testing Webinar
The traditional sterility test is a known limitation for the release of many cell therapies, advanced therapy medicinal products, and especially short shelf-life products. Therefore, therapies are administered at-risk to the patient while awaiting the 14-day compendial test results. This at-risk period is even greater when considering the manual aseptic processing steps involved in their production, in contrast to the primarily closed-loop process in pharmaceutical manufacturing. So why continue to rely on traditional methods to ensure patient safety a week or more after administration, especially when easy rapid solutions exist?
Safely release cell and gene therapies in as little as three days using Celsis Adapt™ and Celsis® ATP-bioluminescence, a pharma-proven rapid method that is compatible with a variety of cell types, densities, and product matrices. As the latest addition to the Celsis rapid microbiological detection platform, the Celsis Adapt™ is designed specifically to remove the cellular debris found in cell and gene therapy samples or in-process cell culture samples. Compatible with both the Celsis Accel® and Celsis Advance II™ instruments, the Celsis Adapt™ expands the utility of Celsis® ATP-bioluminescence for cell-based therapies and faster results.
Watch our on-demand webinar where you’ll learn:
- How Celsis Adapt™ works for cell-based samples, where it fits into manufacturing processes, and the various applications for use.
- The regulatory landscape of cell-based products and the validation requirements for samples tested utilizing Celsis Adapt™.
- Challenges of rapid microbial methods for short shelf-life and ATMP testing.
- Successful approaches to proving equivalence to traditional Micro QC methods.
- Services to support the effective implementation of Celsis Adapt™.
