The Massachusetts Institute of Technology and drugmaker Novartis ($NVS) shook hands in 2007 on a 10-year, $65 million collaboration aimed at pulling pharma out of the batch age to capitalize on the efficiencies of continuous processing. The Novartis-MIT Center for Continuous Manufacturing is now in its fourth year. We checked in with the center's director, MIT professor Bernhardt Trout.
FiercePharma Manufacturing: What's the center's objective?
Trout: To develop a portfolio of technologies that will transform pharmaceutical manufacturing from batch to continuous processes, where "continuous" means a fully integrated, systems approach, in addition to continuous flow. Continuous manufacturing is where we think the industry is going.
FPM: Why did this need to be a 10-year effort?
Trout: It's a major project overall, transforming an industry.
In a sense, pharma is most behind in developing technologies for manufacturing.
The work is actually two 5-year projects, and we're working on the renewal contract now. Five years is a good amount of time for developing cutting-edge technology. In the second 5 years, we'll expand the research.
FPM: What have you been working on?
Trout: We do a lot of work on crystallization, on making solids.
We continue to work on new chemistry challenges: catalyst composition (moving from homogeneous to heterogeneous), solids and clogging, separation processes, and new ways of creating solid dosage forms.
We've also done end-to-end process R&D at our bench-scale, non-GMP facility.
FPM: Name a breakthrough from the center.
Trout: We saved a lot of time in a process step involving a corrosive chemical, which you wouldn't want to keep hanging around. Using continuous processing we completed this chemical step in 5 minutes, down from 8 hours.
FPM: What are some challenges you've faced along the way?
Trout: When we started the end-to-end process development work, we did a lot of troubleshooting and fixing. We also had some nice surprises when some processes worked as expected.
FPM: How is the work going overall?
Trout: We're doing well, meeting milestones. Like others in technology development, we've "wrapped up" some projects earlier than intended.