Endosafe® Trillium® Recombinant Cascade Reagent (rCR)

Our recombinant cascade reagent uses recombinant DNA technology to produce the critical biological proteins of LAL using lab-engineered alternatives. Trillium simulates the natural LAL reaction through an optimized formulation of three critical biological proteins (Recombinant Factor C, Recombinant Factor B, and Recombinant pro-clotting enzyme). This proprietary matrix demonstrates assay superiority in accuracy, comparability, and robustness compared to other recombinant endotoxin detection technologies and our primary validation data in water supports the claim of equivalency to LAL.

Trillium utilizes a 3-Factor enzymatic cascade formulation that mimics the reaction as a traditional LAL cascade. rFC is an endpoint method and only contains a single protein in the cascade. Trillium has been specifically developed to provide the highest quality results among recombinant technologies. Products like rFC, that contain only one enzyme, require external amplification obtained by a fluorescence reader, and does not mimic the natural LAL amplification enzyme cascade. Utilizing a product that requires fluorescence amplification requires the end users to purchase new equipment, onboard and train users, and employ a completely different methodology.

Trillium rCR is an animal-free addition to our bacterial endotoxin detection portfolio. Not all products may work with recombinant technology, and therefore, we will continue to manufacture LAL.

Bringing Trillium recombinant cascade reagent to market gives customers an animal-free option that closely resembles what has been tested and proven in nature (LAL). Our research and product development team have spent an abundance of time truly understanding the sensitivity and composition of our formulation and the severe impact on potential for underestimation of endotoxins. As all formulations are different from vendor to vendor, the slightest change can alter the ability to detect or not detect natural environmental endotoxins. So as scientists do, we tested, challenged, and tested again to ensure the highest quality product for our customers.

Our team remains vigilant and committed to our 3Rs initiative and horseshoe crab sustainability efforts. Our recombinant technology allows us to optimize our resources while continuing our mission to reduce reliance on the horseshoe crab by innovating our formulations and microfluidics technology to enrich the LAL assay. LAL is still necessary to manufacture as recombinant technologies are not able to be utilized on all products, so we are committed to collecting this valuable natural resource in a safe and humane manner that is both environmentally sustainable and ensures medical treatments are safe for patients around the globe.

As with all commercially available recombinant technologies for BET, Trillium recombinant cascade reagent does not yet have the years of comparative data laboratory experts have come to rely on that shows the high level of accuracy of the natural variation. Our primary validation data supports the claim of equivalency to LAL. Users would need to perform their own product-specific alternate method valid+

We provide a pathway to faster submission and implementation with a primary validation support package that includes protocols and a primary validation summary report. With over 40 years of endotoxin testing, troubleshooting, and methods development experience, our skilled technical teams are an extension of your team, providing guidance and support throughout your implementation.

Today, the FDA will not currently license recombinant reagents in the same way they license LAL. We will continue to work with the FDA in an attempt to have recombinant reagents regulated. As an FDA-regulated facility, we follow the same quality control and manufacturing protocols as we do for our licensed reagents, and welcome our customers to audit our facility and process as necessary.

It's important to note that global regulatory bodies recognize recombinant cascade reagents as a valid alternative testing method to traditional, compendial bacterial endotoxin testing methods. Trillium rCR meets stringent validation requirements, providing comparable results to the compendial method. By partnering with us, you can have confidence in meeting regulatory standards while driving sustainability forward.

Trillium is a kinetic chromogenic method and is compatible with existing incubating absorbance plate readers, Endosafe® EndoScan-V™ software, and testing accessories, reducing the learning curve, creating cost efficiencies, and making testing easier and more reliable. This allows customers to eliminate additional capital costs and fully supports recycling initiatives of electronic lab instrumentation waste.