Introduction of recombinant Cascade Reagents as sustainable and innovative solution for automated Bacterial Endotoxins Testing.

Introduction of recombinant Cascade Reagents (rCR) as sustainable and innovative solution for Bacterial Endotoxins Testing (BET) within the Pharmaceutical Industry. Recombinant Cascade Reagents (rCR) can be used as an alternative to traditional Limulus Amebocyte Lysate (LAL) tests for eg water sample testing. For many years endotoxin testing has relied on LAL derived from horseshoe crab blood but scientists developed recombinant- and commercially available alternatives which utilize the same enzymatic cascade as traditional LAL reagents but are produced through recombinant DNA technology. This approach enhanced specificity by removing the potential for cross-reactivity with 1,3-β-D-glucans. MSD Animal Health showed equivalent potency of different water borne microorganisms in Water For Injection samples to conventional chromogenic lysate in Sievers eclipse, an easy in use, robust and innovative BET platform which meets all requirements and was validated according to the harmonized pharmacopeia.

– Wiet Cuenen –

This presentation is given in English.