Nature of Business
Charles River Laboratories provide the most comprehensive, integrated portfolio of drug development products and services available from a single global provider, spanning the continuum from early research to the support of marketed products. Whether we are helping to chart the course from bench to clinic or working to achieve a particular study milestone, we are proud to partner with our clients on their journey of bringing new therapies to market.
The Microbial Solutions division strategically built our portfolio to bring you progressive products and services that deliver accurate, relevant and reliable data to fuel confident decisions on product quality and contamination control. Our unique combination of Endosafe® endotoxin testing, Celsis® rapid microbial detection, and Accugenix® microbial identification and strain typing keeps your manufacturing operations running efficiently and smoothly, lowers your cost to manufacture and protects your reputation.
Test Services:
- LAL bacterial endotoxin tests
- Accugenix® microbial identification
• AccuGENX-ID® (DNA sequencing for bacterial & fungal identification)
• AccuPRO-ID®
(Proteotypic method using MALDI-TOF, powered by Accugenix® validated library with fall through sequencing)
• AccuGENX-ID® ProSeq (Protein coding gene sequencing)
• AccuGENX-ST® (Strain typing)
• Tracking & Trending data management tool (Environmental monitoring)
- Microbial enumeration & specified microorganism detection
- Bioburden test
- Sterility test
- Environmental monitoring
- Disinfectant qualification studies
- Sterilisation validation support
- Rapid glucan detection
- Mycoplasma detection (RT-PCR)
- Custom microbiology method development
Products:
Endosafe® Endotoxin Testing Products
- nexgen-PTS™ and nexgen-MCS™ LAL cartridge readers
- Nexus™ fully automated robotic system
- EndoScan-V™ software
- Cortex™ data management software
- LAL reagents and test accessories
- Microplate readers
- Method development and validation services
- Troubleshooting support
- Instrumentation services (PM, calibration, IOPQ)
Celsis® Rapid Microbial Detection Products
- Celsis Accel® and Advance II™ systems
- Celsis® reagents and accessories for rapid sterility and bioburden test
- Celsis® ADAPT for cell and gene therapy rapid sterility testing
- Celsis® feasibility testing and equivalency studies
- Troubleshooting support
- Instrumentation services (PM, calibration, IOPQ)
AccuGENX-ID® microbial identification
- AXCESS® MALDI - TOF for microbiology testing
- Conidia IDFP plates for fungi