Q:

When performing a Lonza Bacterial Endotoxin Test (BET), LAL or PyroGene™ Recombinant Factor C (rFC), endotoxin detection assay should I use matched reagents, lysate/CSE?

A:
You need to use matched reagents in order to comply with FDA requirements for endotoxin testing. Each Lonza LAL lot is tested for functionality using United States Reference Standard EC-6. We then match” this LAL lot to a lot of our Control Standard Endotoxin (CSE) by testing in parallel with the referenced standard endotoxin (RSE). This RSE/CSE correlation assay determines the potency of that lot of CSE when used with that lot of LAL. Procedures for the RSE/CSE correlation assay are taken from the FDA Guideline on the validation of the Limulus Amebocyte Lysate test as an end product endotoxin test for human and animal parenteral drugs, biological products, and medical devices. The FDA has stated that the use of a certificate of quality from the LAL manufacturer exempts a firm from having to perform the RSE/CSE comparison on their own. Lonza makes your endotoxin testing simpler by offering kits containing matched reagents for all of our assay types.
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Categories:
Endotoxin Detection
Research Areas:
Endotoxin Testing