WEBINAR: Biomanufacturing Assumes Central Role in Cell and Gene Therapies
Recorded November 4, 2020
Cell and gene therapy products represent some of the most exciting new drugs that biopharmaceutical companies are looking to bring to market.
Based on recent clinical successes, an increasing number of cell and gene therapies are currently in clinical development. However, despite the tremendous amount of clinical activity, manufacturing these products remains challenging. Consistently manufacturing a cell therapeutic with critical quality attributes, generating high-quality gene therapy vectors, and transitioning from small product lots to commercial size production are just a few challenging areas.
Although the U.S. Food and Drug Administration (FDA) does not have all the answers, it is committed to advancing product development through applied scientific research, policy development, flexible application of regulations, optimal application of expedited development programs, and ongoing dialogue with product developers.
In this GEN Keynote webinar, Dr. Peter Marks, director of the Center for Biologics Evaluation and Research (CBER) at the FDA, discussed how CBER is providing oversight to organizations during the critical developmental and manufacturing stages for biological products, as well as throughout the product life cycle.
Peter Marks, MD, PhD
Director of the Center for
Biologics Evaluation and Research