Design Day Seminar - Live Stream
Abstract: CAR-T cells have been proven clinically to be life-saving therapies for a number of hematological cancers, and offer further promise for additional hematological indications as well as for solid tumors. Commercializing these CAR-T therapies offers numerous challenges in all areas of drug developement, including manufacturing and supply chain. Raw material procurement, patient tracking, cost-effective and robust manufacturing, process changes and comparability, process and assay validation, QC/QA release, manufacturing facility strategies, staffing models, and cold supply chain are among the many technical challenges that will be discussed in this presentation.
Greg Russotti is currently Vice President of Cell Therapy Technical Development at Celgene Corporation and is responsible for process development, analytical method development, product sciences and process/assay support for clinical and commercial manufacturing for cell therapy products. Prior to joining Celgene in 2006, Greg spent 15 years at Merck Research Laboratories developing products that included live virus vaccines, monoclonal antibodies, recombinant vaccines, and microbially-produced natural products. He worked on development, scale-up, and tech transfer of cell culture, microbial fermentation, and downstream isolation processes to clinical and commercial manufacturing facilities. Greg received his B.S. and M.S. degrees in Chemical Engineering from RPI and his Ph.D. in Chemical and Biological Engineering from Rutgers University.