A3P webinar Endotoxins
Recombinant assays / Endotoxin testing / Alternative methods
Introduction
This study aims to evaluate the performance of various recombinant assays as potential alternatives to compendial assays for testing water and different types of drug products. The assays compared include two recombinant Cascade Reagents, two recombinant Factor C reagents, a Kinetic Turbidimetric Reagent, and a Kinetic Chromogenic Reagent. The study design involved testing these assays across a range of matrices and endotoxins, including RSE, CSE, and in-house produced NOE solutions. The results indicated that one recombinant assay performed on par with the compendial assays, while the other recombinant assays showed varying degrees of performance. Some NOEs from waterborne microorganisms seemed to be challenging in detection with recombinant reagents. This study highlights the potential of recombinant assays in providing reliable and effective alternatives to traditional compendial assays for endotoxin testing in pharmaceutical products.
This workshop is organized by the A3P Italy Committee