CAR-T manufacturing: delivering on the promise of a transformational therapy
January 15-19, 2017
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.
Greg Russotti, "CAR-T manufacturing: delivering on the promise of a transformational therapy" in "Scale-up and Manufacturing of Cell-based Therapies V", Tom Brieva, Celgene Cellular Therapeutics William Miller, Northwestern University Chris Mason, University College London Eds, ECI Symposium Series, (2017). http://dc.engconfintl.org/cellbasedtherapies_v/74