A robust and valid non-animal derived bacterial endotoxin test
We continue to apply the highest scientific standards when offering new and innovative products in our bacterial endotoxin testing (BET) portfolio. The development of a recombinant BET consisting of a 3-factor enzymatic cascade was dependent and critical on the generation of relevant data from product inception to the final formulation. This rigorous and comprehensive development has resulted in Endosafe® Trillium™, a recombinant cascade reagent (rCR) assay. Our animal-free option for bacterial endotoxin testing provides confidence and safety in product manufacturing while simultaneously strengthening a united commitment to the 3Rs (Replacement, Reduction, and Refinement) and sustainability initiatives.
These technical reports detail the robustness and validity of our Endosafe® Trillium™ rCR matrix and formulation from our customer beta studies, highlighting assay equivalency to our FDA-licensed kinetic LAL assay in both vials and cartridges via our primary alternate method validation. Data provided in this report will further assist in the decision-making process for implementing a suitable non-animal derived bacterial endotoxin test.