Charles River Laboratories International, Inc.

May 14, 2008
Rapid Endotoxin Testing Solution Supports PAT Initiatives

To meet the increased market demand for rapid, real-time endotoxin testing, Charles River Laboratories International, Inc. developed the Endosafe-MCS, a multi-cartridge testing system. This in vitro solution supports the FDA’s Process Analytical Technology (PAT) initiative by providing real-time test results on critical path samples. The MCS system helps customers produce samples faster for high throughput which improve operational efficiencies.   

Rapid Assay Expedites Testing

The MCS system leverages Charles River’s expertise in rapid endotoxin detection from the Endosafe-PTS. The Endosafe-MCS expands the number of tests which can be performed simultaneously from one to five. The solution uses disposable FDA-licensed LAL test cartridges which are preloaded with all the reagents necessary to perform an endotoxin test. Quantitative test results are available in just 15 minutes and the system permits random access of samples. The Endosafe-MCS and Endosafe-PTS systems accelerate the discovery and development of new drugs by offering quick and easy endotoxin test results, which saves pharmaceutical companies, medical professionals and scientists both time and money in the manufacturing process.

Additional customer benefits include:

  • Reduces number and cycle time of process steps
  • Improves efficiency and productivity by decreasing downtime
  • Minimizes errors and reduces risk
  • Provides improved sample management
  • Prevents bottlenecks and hold steps in the development process