SCANRDI® CELL-BURST
Same-shift sterility testing for cell & gene therapies
SCANRDI®’s speed and sensitivity continue to revolutionize rapid microbial detection through its unique technology. Removing sterility testing as a bottleneck, the CELL-BURST solution completes the system and provides an ultra-rapid method to enable earlier release and accelerate patient access to life-saving therapies.
- Overview
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When You Need to Know Now
CELL-BURST is the first same-shift sterility test for Cell & Gene Therapy products, with proven equivalency to compendial methods.
Combined with our SCANRDI® system, the patented protocol delivers actionable sterility results within the same shift – enabling you to act immediately if needed.
With SCANRDI® CELL-BURST, you can invest now to future-proof your sterility results and help support long-term leadership in addressing urgent challenges:
- Help drastically reduce the time required to deliver your life-saving therapies to patients in need
- Rely on a proven method that is broadly applicable to current therapies and intended to support future therapies.
CELL-BURST is a cell-based ultra rapid sterility test combining the solid-phase cytometry of the SCANRDI® with a patented protocol that renders cell-based matrices easily filterable.
About solid-phase cytometry:
The CELL-BURST Protocol relies on 3 steps only and does not require growth:
Filtration of the sample through a membrane
Labeling of the microorganisms with a fluorochrome dye becoming active through the microorganisms’ enzymatic activity à only living microorganisms will be labeled and detected
Laser scanning using the SCANRDI® instrument
The results are displayed in a 21 CFR Part 11-compliant software environment.
Compatibility with the following cell-types has been tested:
* non-exhaustive list
Services: Feasibility, Validation, and Instrument Support
Your productivity and product quality are our priority. At bioMérieux, we aren’t just selling fast and reliable solutions – our technical team and scientific experts are fully committed to help you get the most out of your equipment, to ensure the continuity of your operations.
From feasibility, to installation and IT integration and training, our entire range of services can be customized to your needs throughout your whole journey with us, focusing on your core business and optimizing your resources.
Resources
BROCHURE - Boost Cell & Gene Therapy Production Efficiency
DISCOVER OUR COMPREHENSIVE PORTFOLIO
- Filename
- PHARMA-BROCHURE-CGT-ACCELLIX-A4-05-23-9324115-Pages.pdf
- Size
- 2 MB
- Format
- application/pdf