Cell and Gene Therapy CMC and Manufacturing: Ensuring the Analysis, Production and Quality Robust and cost-effective characterization and manufacturing presents a core challenge in the commercialization of gene and cell therapies with pressure mounting on CMC, analytical and manufacturing teams to keep up with accelerated development times and cost pressures. Gene and Cell Therapy CMC and Manufacturing examines the critical challenges facing the production, characterization and quality control of gene and cell therapies, with dedicated presentations on rapid CMC development, product and process characterization, upstream and downstream bioprocessing and considerations for personalized and large-scale manufacturing.
Transformation from R&D to Manufacturing
James Warren, PhD, Vice President Pharmaceutical Development
Re-thinking Comparability Assessments for Individualized Therapeutics?
Kathy Francissen, PhD, Senior Director, Pharma Technical Regulatory
Genentech, A Member of the Roche Group
Virtual Inspections: Navigating the New Paradigm
Monica M. Commerford, PhD, Manager of Regulatory Affairs