Sterility testing is the primary bottleneck in advanced therapy release, with compendial methods and safety margins applied to alternative rapid growth methods typically resulting in release timelines of 7–14 days.
Symcel has a strategic collaboration with Johnson & Johnson aimed at delivering a validated, GMP-compliant sterility test that reduces release timelines to under three days, improving manufacturing efficiency and enabling faster patient access.
Based on the calScreener® biocalorimeter platform, the calScreener+ Sterility system detects microorganisms via their metabolic heat, enabling rapid and highly sensitive growth-based detection of viable contaminating microorganisms.
In this upcoming webinar, Dr. Wilhelm Paulander, Chief Clinical Development Officer at Symcel, will present the latest developments and validation data for the calScreener+.
What you will learn
- An introduction to the calScreener+ biocalorimeter platform and its role as an RMM in cell and gene therapy manufacturing
- A workflow enabling direct inoculation of complex product matrices and non-destructive measurements.
- Presentation of latest primary validation data including robustness, ruggedness, specificity, and limit of detection (LOD)
- Implications of USP safety margins for slow-growing organisms such as C. acnes
- Examples from data presented by Johnson & Johnson comparing time-to-detection using the calScreener+ system for sterility testing
Feb 11, 16:00 – 17:00 CET | 10:00 – 11:00 ET
