Validation Of Endotoxin Testing For CAR T-cell Manufacturing Quality Control...

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Presented by Dr. Zlatibor Velickovic PhD at Royal Prince Alfred Hospital and Alan Hoffmeister at Charles River Laboratories

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Full Title: Validation Of Endotoxin Testing For CAR T-cell Manufacturing Quality Control & Benefits of Cartridge Technology During manufacture of CAR T-cells there is a risk of contamination of the final product and/or materials with endotoxins. Endotoxins are lipopolysaccharide molecules produced by gram-negative bacteria that can cause toxic reactions in patients and lead to serious complications.  Endotoxins can be detected reliably by the limulus amoebocyte lysate (LAL) test. Endosafe nexgen-PTS, (Charles River) is a portable system designed to read cartridges loaded with LAL reagents and endotoxin control. Each cartridge is supplied with a predetermined spike recovery with two sample and two spiked channels enabling quick and easy endotoxin detection. Materials used in cell manufacturing may interfere with the test and therefore validation of bacterial endotoxin testing (BET) is mandated for each cell product. We’ll present the validation approach for endotoxin testing using Endosafe nexgen-PTS designed to meet Australian regulatory requirements. In this webinar, you will learn from our experts: Introduction to cartridge technology and its benefits How the Endosafe nexgen-PTS provides a rapid quantitative method for Endotoxin detection in CAR T-cell products. Why Maximum Valid Dilution (MVD) needs to be calculated and validated for each CAR T-cell product formulation and volume of infusion. Why it is important to perform interference testing using I/E cartridges and serial dilutions of the CAR T-cell product up to the MVD.

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