Bacterial Endotoxin Testing – why the horseshoe crabs are celebrating!
CBE Pure Solutions, as a part of its environmental, social, and corporate governance (ESG) objective to avoid the use of animal products is excited to announce that we are able to offer our clients an alternative bacterial endotoxin test method using non-animal derived reagents through the Recombinant Factor C method.
The Recombinant Factor C (rFC) is a single-component, single step, sensitive and specific assay for bacterial endotoxin. It only requires a fluorogenic substrate to produce a fluorescence readout, to measure endotoxin. With the enhanced advantage rFC acts independently and does not suffer interference from other LAL proteins, offering greater product testing diversity.
Until now the LAL method has been largely the accepted compendial test and the Horseshoe crabs have been integral to the safe production of vaccines and injectable medications. Live horseshoe crabs are bled to extract a protein in the blood called Limulus Amebocyte Lysate (LAL), which has been an essential component in endotoxin testing up until now. In the US alone more than half a million are captured for bleeding [1].
rFC has been accepted by the EP/BP since 2021and the US Pharmacopeia Microbiology Expert Committee has voted in favour of adopting a new chapter, “Chapter <86> Bacterial Endotoxins Test Using Recombinant Reagents” which endorses the use of non-animal derived reagent for endotoxin testing. Chapter <86> will be available for early adoption in November 2024 this year and will become official in May 2025.
CBE Pure Solutions is now offering through their TGA licenced laboratory fully validated ENDONEXT bacterial endotoxin testing.
Enquire about testing and joining our journey for a sustainable future. Stay tuned for our other tests at the forefront.
[1] Gorman R. Atlantic Horseshoe Crabs and Endotoxin Testing: Perspectives on Alternatives, sustainable Methods, and the 3Rs (Replacement, Reduction, and Refinement). Front Mar Sci. 2020 Sep 30;7:fmars.2020.582132. doi: 10.3389/fmars.2020.582132. PMID: 35591980; PMCID: PMC7612741.