Cell Therapy Development: Tackling Analytic Challenges
Date: January 24, 2022, 11:00 am - 12:00 pm ET
Cell therapy products are an exciting new class of medicinal products that offer opportunities to treat and cure diseases that cannot be treated using conventional therapeutic options. The development and manufacturing of cell therapy products pose several challenges compared to other biologics. Yet these products must be held to the same critical standards of quality and purity to assure patient safety. Cell-based medicinal products cannot be sterilized through filtration like other pharmaceutical drugs. Yet, particle contaminations, both visible and subvisible, need to be identified, characterized, and controlled during product development and manufacturing, to allay potential safety concern of particulates when administered by injections. Cells in suspension are subvisible in nature, and distinguishing them from impurities presents a unique challenge.
In this inaugural GEN Protocols: Monday Mixer our participants will discuss how purity of cell therapy products can be assessed at low volumes, and purity assays of T cell products for cancer and human Schwann cell therapy products. This discussion is relevant for scientists involved in the development and production of cell-based drugs who are faced with the challenge of testing the purity of their products in limited volumes.
A live Q&A session will follow the presentations, offering you a chance to pose questions to our expert panelists.
Bernardo Cordovez, PhD,
CSO, Founder CSO/ Halo Labs
Juan F. Vera, MD,
Assistant Professor, Baylor College of Medicine and
Chief Product Development Officer, Marker Therapeutics
Paula Monje, PhD,
Associate Research Professor of Neurological Surgery, Stark Neurosciences Research Institute,
Department of Neurological Surgery, Indiana University School of Medicine