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.
Based on the calScreener® biocalorimeter platform, the calScreener+ Sterility system detects microorganisms through their metabolic heat, providing rapid and highly sensitive growth-based detection of viable contaminants. Time to results is typically under one day for most bacteria, around two days for fungi, and—most importantly—three days or less for challenging, time-limiting slow growers.
In this 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)
- Evaluation of matrix effects on microbial detection
- Implications of USP safety margins for slow-growing organisms such as C. acnes
