By Angie Drakulich, Editorial Director, Pharmaceutical Technology / BioPharm International
The industry is increasingly adopting continuous processing models as it works to gain better process understanding and control, an approach that is being encouraged by regulators under the QbD paradigm. The continuous approach also aims to offer manufacturing flexibility and reduced costs and resources. Next month, at INTERPHEX 2012, taking place May 1-3 at the New York City Javits Center, PharmTech will be discussing this issue with a unique, high-level panel.
The panel, being held May 1st at 10:30 AM, will feature: Dr. Elaine Morefield, the Deputy Office Director for Review and Operations in the Office of New Drug Quality Assessment at FDA; Dr. Moheb Nasr, the Vice President, of CMC Regulatory Strategy in Global Regulatory Affairs at GlaxoSmithKline, and the former Director of the FDA Office of New Drug Quality Assessment; Dr. Fernando J. Muzzio, the Director of NSF ERC on Structured Organic Particulate Systems, and a Professor in the Department of Chemical and Biochemical Engineering, at Rutgers University; and Dr. Suneela Prodduturi, the director of Pharmaceutical Technologies at Steer Engineering.
We hope to address changes and challenges tied to implementing a continuous manufacturing with a specific focus on unit operations and control strategies, regulatory expectations, and the future of this approach. We hope to see you there.
In the meantime, we want to hear from you. What is your company doing to implement a continuous approach? What challenges is it facing? What best practices can you offer? Share your comments and we may be able to work them into the panel discussion or future article.