Pain points to potential: Positioning process and analytical development for next-gen cell therapies

Starting with an education in microbiology and immunology I have built my analytical development experience from nearly 20 years spent in in-vitro diagnostics and cellular therapies worlds. Working for multiple companies with various technologies has provided experience in fields such biomimetics, cell therapy, immunology, in-vitro diagnostic development, process and assay development and clinical trial management. Pulling from lessons learned in such experiences allows me to approach the challenges faced in analytical development with a broad perspective and to find unique and robust solutions to address said challenges. In my current position I lead both the analytical development team, where assays go from ideas to a defined purpose and procedure, and the GMP Analytical testing lab where the developed assay is qualified for its purpose and used. I find both sides of this work exciting and challenging.

Alex Sargent – better known as “Sarge” – is currently the Director of Process Development at Charles River Laboratories. He obtained his PhD from Case Western Reserve University in Cleveland Ohio, where he studied the challenges and promises of stem cell biology, neuroimmunology, and Cleveland sports teams. After a brief stint in academia at the Cleveland Clinic, he left Cleveland to pursue his industry career in cell therapy. During his many years in this industry, he has had the honor of working at several esteemed enterprises on new technologies and approaches for cell therapy scale up, automation, and gene editing. He is especially passionate about the challenge of curing cancer, working on CAR-T and CAR-NK cell therapy process and analytical development from discovery, through regulatory submission, manufacturing, and pivotal clinical trials. He wakes up each day excited to help advance cell and gene therapy to treat and cure disease, with the steadfast goal of improving human lives.