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.


Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.