Over the past decade, drug shortages and product recalls in the U.S. have occurred at unprecedented rates, limiting patient access to critical medicines and undermining health care. A majority of these shortages and recalls have been due to manufacturing quality issues. In response to these problems, and as part of its ongoing efforts to ensure a continuous supply of high-quality pharmaceuticals in the U.S., the U.S. Food and Drug Administration (FDA) is pursuing a range of strategies designed to improve the flexibility, reliability, and quality of pharmaceutical manufacturing. Among these strategies is the promotion of new manufacturing technologies, including continuous manufacturing. Continuous manufacturing offers several important advantages over current approaches to manufacturing and has the potential to significantly mitigate the risks of quality failures. At present, however, these technologies and processes are not widely used by the pharmaceutical industry, and there remain a number of barriers to their broader adoption. In collaboration with a range of stakeholders, FDA is currently exploring ways in which it can help to address these barriers and facilitate the uptake of new manufacturing technologies.
Under a cooperative agreement with FDA, the Center for Health Policy at Brookings held a workshop on October 19 entitled “Promoting Continuous Manufacturing in the Pharmaceutical Sector.” This workshop provided an opportunity for industry, academia, and government partners to identify the major barriers to the adoption of continuous manufacturing, discuss regulatory policies and strategies that could help to address those barriers, and explore approaches to improving public and private sector alignment and collaboration to promote the adoption of continuous manufacturing.
Promoting the adoption of continuous manufacturing in the pharmaceutical industry: The FDA perspective
9:15 am - 9:30 am
Session I: Assessing the current landscape and future direction for continuous manufacturing
9:30 am - 10:30 amAlastair Florence Professor of Pharmaceutical Science & Director, EPSRC Centre for Innovative Manufacturing in Continuous Manufacturing and Crystallisation - University of StrathclydeFernando Muzzio Director, Center for Structured Organic Particulate Systems, & Distinguished Professor, Chemical and Biochemical Engineering - Rutgers University
Session II: Improving scientific and technical knowledge to support continuous manufacturing
10:45 am - 12:00 pmRichard Braatz Edwin R. Gilliland Professor of Chemical Engineering - Massachusetts Institute of TechnologyEugene Choi Technical Advisor to the Defense Advanced Research Projects Agency - Strategic Analysis, Inc.Mel Koch Principle Scientist, Center for Process Analysis and Control (CPAC) - University of Washington
Session III: Addressing barriers to the adoption of continuous manufacturing
1:00 pm - 2:30 pmJohannes Khinast Head of the Institute of Process and Particle Engineering, & Scientific Director, Research Center of Pharmaceutical Engineering (RCPE) - Graz University of Technology
Session IV: Building stakeholder collaborations to facilitate the implementation of continuous manufacturing
2:45 pm - 3:45 pmGintaras Reklaitis Burton and Kathryn Gedge Distinguished Professor of Chemical Engineering - Purdue University