Validation Of Endotoxin Testing For CAR T-cell Manufacturing Quality Control & Benefits of Cartridge Technology



28th October 2021 | 4:00pm AST / 6:00am GMT | Dr. Zlatibor Velickovic PhD Production Manager | Department of Cell & Molecular Therapies, Royal Prince Alfred Hospital Sydney, Australia, ISCT Regional Vice-President Elect, Australia & New Zealand and Alan Hoffmeister Senior Global Technology & Market Development Manager, Charles River Laboratories |WATCH FOR FREE

During the 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 samples 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.

Presented by Dr. Zlatibor Velickovic PhD Production Manager | Department of Cell & Molecular Therapies, Royal Prince Alfred Hospital Sydney, Australia, ISCT Regional Vice-President Elect, Australia & New Zealand

Zlatibor Velickovic obtained his BSc degree in Molecular biology and Physiology at the University of Belgrade and his PhD in Immunogenetics at the University of Otago. After completing his doctorate in 2001, he commenced his scientific career at the Australian Red Cross Blood Service (ARCBS) in Sydney. His role as a Senior Scientist at the ARCBS involved the development and implementation of DNA sequencing HLA typing methodology for patient and donor matching in haematopoietic stem cell and solid organ transplantation. Zlatibor authored a number of publications during this time with a focus on the characterisation of polymorphisms of genes involved in immunity and transplantation. He gained extensive GMP knowledge and experience during his years at ARCBS where he was able to successfully obtain and maintain laboratory TGA accreditation. Using his GMP expertise, he set up and validated a newly built facility at the Royal Prince Alfred Hospital, the Department of Cell & Molecular Therapies (CMT), in 2012. He is currently the Production Manager at CMT, managing the facility and production activities for numerous in-house and industry sponsored cell and gene therapy projects. Alongside this, Zlatibor is a Research Fellow at the Faculty of Medicine and Health at the University of Sydney and the International Society for Cell & Gene Therapy (ISCT) Regional Vice-President Elect, Australia & New Zealand.
Followed by Alan Hoffmeister Senior Global Technology & Market Development Manager, Charles River Laboratories

Alan Hoffmeister is the Senior Product Specialist for the Microbial Solutions division of Charles River Laboratories. His experience with the bacterial endotoxins test dates back to 1988, during which time he has been involved in all aspects of the assay, including the design and development of BET-specific instrumentation and software.
He has directed workshops and training courses and lectured internationally on a variety of BET-related topics, including LAL methodologies, system qualification, product validations, 21 CFR Part 11, process analytical technologies (PAT) and BET regulatory affairs. He has also contributed to the development of many BET protocols, technical sheets and monographs for domestic and international organizations.
Sponsored by Charles River Laboratories


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