Manufacturing and Bioprocessing – Biomolecular
2019 PharmSci 360
The Center for Biologics Evaluation and Research at FDA (CBER) is responsible for a portfolio of complex biologic products including vaccines, blood products, and cell and gene therapies. Though the products that are regulated by CBER are diverse in nature, they share in common a key feature: quality manufacturing is central to product safety and efficacy. CBER aims to provide global leadership in helping to advance the quality manufacturing technologies necessary to facilitate the availability of innovative new medicines for the benefit of patients. It also aims to advance the development and availability of these important products through the conduct of applied scientific research, thoughtful application of regulatory principles, and provision of timely advice to those developing products.