A Structured Path to Non-animal-derived BET Validation

Recombinant endotoxin testing has earned regulatory recognition, and for many labs, the next question is how to validate the method in a way that withstands scrutiny. That question slows adoption more often than the science does, because many recombinant reagents leave validation planning to the lab.

Endosafe® Trillium™ recombinant cascade reagent (rCR) uses a three-factor enzymatic cascade that simulates the limulus amebocyte lysate (LAL) reaction using recombinant proteins. To support labs with adoption, Charles River developed a primary validation data package demonstrating equivalency to LAL, comprehensive validation support, and a four-part expert-led training series:

  • Module 1: Cartridge validation, product approach
  • Module 2: Vial validation, product approach
  • Module 3: Cartridge validation, water approach
  • Module 4: Vial validation, water approach

One registration gives you access to all four modules. 

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