2019 CBE Design Day Seminar

"CAR T Cell Therapy Manufacturing: Delivering on the Promise of a Transformational Therapy." 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 development, 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. Dr. Greg Russotti is Vice President of Cell Therapy Technical Development at Celgene Corporation, responsible for process development, analytical method development, product sciences and product/assay support for clinical and commercial manufacturing for cell therapy products. Greg is an alumni of the Chemical and Biological Department, having received his B.S. and M.S. degrees in Chemical Engineering from Rensselaer Polytechnic Institute.