2:43 PM
 | 
Nov 15, 2018
 |  BC Innovations  |  Tools & Techniques

Benchtop manufacturing gets smaller

MIT scientists manufacture therapeutic-grade proteins with a benchtop system

MIT scientists continue to break new ground in benchtop manufacturing systems for biologics. Published in Nature Biotechnology last month, the latest advance from the institute centered on an automated, closed system capable of producing clinical-grade therapeutic proteins in three days.

Christopher Love, who led the project, says his Integrated Scalable Cyto-Technology (InSCyT) system brings the field closer to a vision of regionalized, small-footprint production.

“With some added containment and controlled space these systems we’ve built would let you establish small, efficient facilities,” Love told BioCentury. “You could consider manufacturing even at the level of a hospital or a pharmacy.”

Love, who is a professor of chemical engineering at the Massachusetts Institute of Technology, thinks the system could be useful for responding to viral outbreaks and battlefield needs, where “fast, agile and flexible manufacturing is the key.” It could also be a good fit for a variety of personalized medicine applications, or to improve the efficiency of process development.

“For a biopharma, this opens up opportunities to more rapidly test products during discovery all the way to the other end, to make the right-sized batch for a rare disease or personalized medicine,” said Love.

The work follows a series of papers from MIT scientists on microfluidic-based bioreactors for protein production, including a 2015 study in Lab on a Chip by Love and Rajeev Ram, a professor of electrical engineering at MIT.

In Nature Communications in 2016, Ram and Timothy Lu, an associate professor of biological engineering, electrical engineering and computer science, published a study that used the fast-growing yeast strain Pichia pastoris to accelerate protein production 500% compared with traditional methods.

The study described a wallet-sized microfluidics setup that enabled continuous culture of a yeast strain engineered to switch between production of two therapeutic proteins. But because it only produced a handful of doses at a time, the ability to run quality control checks on the material was limited (see “Go Small or Go Home”).

“This opens up opportunities to more rapidly test products during discovery all the way to the other end, to make the right-sized batch for a rare disease or personalized medicine.”

Christopher Love, MIT

The InSCyT system uses Pichia pastoris to produce batches of 10-1,000 doses, enabling a wide range of quality assays sufficient to verify whether the protein product is clinical-grade.

Love’s team used InSCyT to make three FDA approved therapeutic proteins: HGH, IFNA2B and G-CSF. The researchers demonstrated the molecules behaved no differently than their marketed counterparts, suggesting the system could soon be ready for clinical use.

According to Love, his team did in three months what would typically take industry a year and a half.

Daniella Kranjac, founding partner of Dynamk Capital, which invests in life sciences tools and services companies, told Biocentury Love’s work is “a great example” of how academics are leading...

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