Trout forges ahead on Novartis-MIT continuous processing effort

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.

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