biotactical

Startup

biotactical is developing a rapid sterility test for pharmaceutical manufacturing. The current compendial method has a Time-To-Result of 14 days, which is a bottleneck during Quality Control. Our innovation delivers results in 24 hours. We are able to separate somatic cells from bacterial cells, making our test suitable for personalized medicine / ATMPs and other short shelf life products. Our test kit rapidly expands microbial populations to detectable levels. Our luminometer device, using the power of ATP bioluminescence, determines sterility after this brief 24 hour incubation time. Faster sterility testing enables faster lot release and faster production due to accelerated release and in-process testing. Our method is fast, yet simple to use. We optimize the workflow and decrease manual handling, keeping running costs low and sample contamination minimal. To optimize the suitability of our products, we perform feasibility tests with our clients to ensure consistency of short testing turnaround times.