9:40 a.m. – 12:00 p.m., Nov 15, Mile High Ballroom 1ABC
Speakers: Sharmista Chatterjee, Ph.D., Division Director (Acting), U.S. FDA; Stephanie Krogmeier, Ph.D., Sr. Director, Vertex Pharmaceuticals, Inc.; Timothy Stevens, Ph.D., Associate Director
Bristol-Myers Squibb
Advancement in technology has opened the doors for continuous manufacturing of drug products. Several major pharmaceutical companies are working on developing continuous manufacturing processes for either existing products or new products. This session will focus on the following three topics:
1.Regulatory and quality considerations of continuous manufacturing, particularly when transitioning from batch to continuous for an existing product
2.Case studies highlighting challenges associated with developing continuous manufacturing process for existing products
3. Role of enabling PAT to demonstrate process control in a continuous manufacturing process
Continuous Manufacturing of Drug Product—Technical and Regulatory Challenges
