Janet Woodcock, Head of CDER at the FDA, asked us to set up a symposium to align on making continuous pharmaceutical manufacturing a reality! Thus, we held a symposium at MIT May 20-21, 2014 organized by MIT and the Continuous Manufacturing and Crystallisation Consortium (CMAC). In the symposium, a series of white papers was presented, which have been published and links are now available on this website.
The symposium will bring together pharmaceutical company end users, suppliers, regulators and academics to look at accelerating adoption of continuous manufacturing for both small molecules and biologic products and how research groups, globally, might collaborate more to help drive this. This is an enormous opportunity to guide the way in which new technologies and new approaches in the pharmaceutical industry can transform quality, cost and service for the benefit of the patient.
Schematic Vision of Continuous Manufacturing of Pharmaceuticals
Introductory White Paper:
Achieving Continuous Manufacturing
May 20-21, 2014 Continuous Symposium
Clive Badman* and Bernhardt L. Trout†
* GlaxoSmithKline and Centre for Innovative Manufacturing in Continuous Manufacturing and Crystallization † Department of Chemical Engineering, Massachusetts Institute of Technology and Novartis-MIT Center for Continuous Manufacturing
Continuous Manufacturing White Papers
The white papers presented here are a remarkable collection of work, unified by the goal of building upon the in-roads that continuous manufacturing has made in the pharmaceutical industry to turn it into the standard approach. Why this goal, and why now? The pharmaceutical industry is going through a period of great change as it goes over the Patent Cliff. Fewer blockbusters are being discovered, R&D productivity is down, and more molecules are aimed at niche markets. In the face of this, we have to ask do we have the correct architecture for manufacturing in the industry. To date, we have largely been focused on blockbuster manufacturing with large, often separately located, drug substance and drug product facilities. Now is the time to look at new infrastructure with smaller, more agile facilities for end to end manufacture...