As we construct the editorial calendar each year for the coming year, the editors of Pharmaceutical Technology consult just about everyone with an opinion on what topics we should be covering. We ask you, our readers in our annual Reader Assessment Survey, we ask our editorial board members, and other industry experts what topics and technologies will emerge as important in the coming year. Usually, we get suggestions as broad as our coverage, from novel catalysis for API synthesis, to innovative excipients, to novel process analytics, emerging regulations, new drug-delivery paradigms, and novel aseptic approaches to process and fill/finish operations. So it caught us somewhat by surprise when last year these usually disparate opinions converged on a single topic: Continuous processing.
While continuous manufacturing technologies have been a topic kicking around for years now, this year it seemed everyone—regulators, academics, and industrial scientists—were certain that continuous processing would start to become a reality. Yesterday, I attended a meeting hosted by the New Jersey chapter of the International Society of Pharmaceutical Engineers (ISPE) where once again, continuous processing was the topic. Bernhardt Trout, director of the Novartis-MIT Center for Continuous Manufacturing, presented the results from the Center’s ongoing academic work developing the equipment and chemistry that will someday enable end-to-end continuous manufacture of small-molecule solid dosage forms in a paradigm Trout called “ultra-lean, ultra-QbD manufacturing.” Alton Johnson, vice president for Global Manufacturing Services, Marketed Products at Pfizer followed with a presentation describing Pfizer’s ongoing initiatives to implement continuous manufacture for several unit operations.
If the attendance and the Q&A session are any indication, continuous processing is indeed a topic to watch. So much so in fact that Pharmaceutical Technology will be hosting an afternoon of panel discussions and interviews on the topic as part of its Signature Series program at Interphex. We will kick off the presentations on Tuesday, March 29, at 1:30 pm on the Main Stage in the Exhibit Hall, where I will be moderating a panel in which FDA’s Moheb Nasr joins Fernando Muzzio from Rutgers and Alex Cheuh of Pfizer to explore the challenges and benefits of continuous processing as seen by regulators, academics, and industry professionals.
Following the panel presentation, we will continue to explore the topic in one-on-one interviews with James Evans, associate director for the Novartis-MIT Center for Continuous Manufacturing, who will discuss the prospects for developing a start-to-finish manufacturing line for small-molecule pharmaceuticals. Next, in my interview with Invetech’s Vice President for Business Development, Bob Speziale, I’ll explore the prospects for developing a continuous processing line for the large-scale manufacture of therapeutic stem cells. I hope you’ll join us for these presentations.
1:30-2:30: Panel Discussion: Challenges for Continuous Processing
Panelists: Moheb Nasr, Director, Office of new Drug Quality Assessment, CDER, FDA; Alex Cheuh, Director/Team Leader of the Technology, Science and Operations Group, Pfizer Global Supply Division, Pfizer Inc.; Fernando Muzzio, Professor Chemical Engineering, Rutgers University and President, Mixing Consultants, Inc.; Moderator is Michelle Hoffman, Editorial Director, Pharmaceutical Technology
The Future for a Fully Integrated Platform with James Evans, Associate Director Novartis-MIT Center for Continuous Manufacturing.
Automating Stem-Cell Manufacturing with Bob Speziale, Vice President Business Development, Invetech.