RAPID
STERILITY
TESTING
- Rapid detection, full results within 3 days
- Direct inoculation of complex products
- Flexible test volume
- Non-destructive, phenotypic assay
- Continuous monitoring, objective result
The Symcel difference
DOWN TO ONE CFU WITHIN HOURS
Cell and gene therapies need to be available quickly, and they need to be safe. Yet traditional sterility tests’ long turnaround times and complex procedures can lead to long vein-to-vein times and high development costs.
Despite the shift from traditional 14-day testing to faster 7-day protocols, the urgency of modern therapies calls for even greater speed. The calScreener+ is straightforward and remarkably fast and accurate.
Our method enables sterility testing in less than 3 days (see right), cutting time by 60% against today’s rapid alternative methods.
Biocalorimetry
We have repurposed an isothermal microcalorimeter* for biological systems to create our biocalorimeter, the calScreener+. Isothermal microcalorimetry is one of the methods recognized in USP chapter <1071> and EP Chapter 5.1.6. as a rapid microbiological method for sterility testing. The calScreener+ monitors heat generated in the samples and quickly detects any increase in microbial metabolic activity.
By focusing on four qualities – specificity, sensitivity, simplicity and speed – our system delivers state-of-the-art levels of detection speed and accuracy without the need for complex procedures, filtration or other special training.
Try our
solution
Engage with us in a technical and validation discussion. We are happy to provide an evaluation in our labs. With product-assay compatibility confirmed, we will support you throughout the validation.
Blog & publications
This site is dedicated specifically to rapid sterility testing, and we have put together scientific background and data in a range of publications. To stay up to date with all our developments, sign up to our newsletter here.
