Featured News
The Road to Regulatory Approval for Recombinant Cascade Reagents: USP Approves Chapter <86>
As announced by the US Pharmacopeia (USP) on Friday, July 26th, 2024, The USP Microbiology Expert Committee has finalized and approved the inclusion of Chapter <86>, Bacterial Endotoxins Test Using Recombinant Reagents. This significant development permits the use of non-animal-derived reagents for bacterial endotoxin testing (BET), including recombinant cascade (rCR) and recombinant Factor C (rFC) reagents. Publication for early adoption will be released in November 2024 and will become official in May 2025. This timeline allows our partners to plan for the implementation of these innovative testing methods.
Advancing BET with rCR
Charles River's Endosafe® Trillium™ rCR technology offers significant advantages over single-enzyme recombinant alternatives:
- Simplified Workflow: Enables kinetic chromogenic reading without fluorescence detection or gain adjustment
- Improved Reliability: Multi-enzyme system overcomes limitations of single-enzyme reagents
- Easy Preparation: Single-vial format eliminates complex mixing procedures
- Global Regulatory Compliance: One-time alternative validation effort ensures worldwide acceptance
Endosafe® Trillium™ rCR Technical Report
To further demonstrate the robustness and validity of our Trillium rCR matrix and formulation, we published a technical report detailing the results of our comprehensive beta test study program. The report highlights assay equivalency to our FDA-licensed kinetic LAL assay via our primary alternate method validation.
Download the Report
Transition Seamlessly with Endosafe® Cartridge Technology
To support our clients through this industry shift, Charles River offers Endosafe cartridge technology in both Limulus Amebocyte Lysate (LAL) and rCR formulations with Endosafe Trillium. This dual approach provides:
- Flexible Adoption: Gradual transition from traditional to recombinant methods
- Versatile Application: Ideal for high-volume samples like water, with the option to use either LAL or rCR for final product testing
- Consistent Methodology: Uniform testing procedures across samples and sites
- Efficiency and Sustainability: Pre-loaded cartridges minimize hands-on time, reduce contamination risk, and eliminate reagent waste
Supporting Your Transition
To facilitate the implementation of recombinant BET methods, we offer the Endosafe Trillium rCR Primary Validation package. This comprehensive solution includes validation protocols, results, and statistical analysis, designed to streamline the adoption process, and ensure regulatory compliance.
As the industry moves towards more sustainable practices, Charles River remains committed to providing modern solutions that meet the highest standards of quality and regulatory compliance. We stand ready to support our clients through this transition, offering expertise and innovative products to ensure seamless adoption of these new methods.
Our team of experts is available to discuss how these changes may impact your specific operations and to provide guidance on implementing the most suitable BET methods for your needs, whether you choose to adopt new recombinant methods or continue with traditional LAL testing.
Learn more about Endosafe Trillium and available configurations
Learn more about Endosafe Alternative Method Validation Support
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