MIT receives $82m from FDA for continuous mRNA manufacturing platform

With $82 million in FDA funding, MIT will conduct a three-year research program to design a fully integrated continuous mRNA platform.

The Center for Biologics Evaluation and Research (CBER) at the US Food and Drug Administration (FDA) will distribute the funds to Massachusetts Institute of Technology (MIT) over a three-year period.

A significant portion of the program has been subcontracted to ReciBioPham (previously Arranta Bio), which partnered with MIT in May to develop a continuous manufacturing technology for messenger RNA (mRNA) therapeutics as it builds the production plant.

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According to MIT, the program aims to advance society’s capability to respond to future pandemics, as well as fast-tracking the development and manufacturing of mRNA technologies for the treatment of cancers, genetic diseases, and cancers.

“This project has public health significance because a continuous mRNA manufacturing platform has the potential to serve as an adaptable, agile tool to address emerging health threats both in the United States and globally,” says Peter Marks, director of the FDA’s CBER.

The push for continuous production

Continuous manufacturing (CM), whether by perfusion in the upstream or downstream, has become a hot topic as it means fewer staff or equipment is required as it works by constantly producing cells and drugs.

In May 2020, the White House pushed to promote advanced technology for the return of pharmaceutical manufacturing to the US in post-COVID-19 era with a new HEROES Act legislation to revive a proposal to establish national centers of excellence for continuous pharmaceutical manufacturing.

Moreover, the FDA published its final CM guidance in March entitled Continuous Manufacturing of Drug Substances and Drug Products. The guidance aims to help industry develop, implement, and operate lifecycle management processes for CM. Much of the guidance focuses on small molecule chemical entities but the document also offers large molecule makers guidance.

The main goal of this project is to drive the field of mRNA therapeutics through providing a continuous manufacturing template for others in the industry to follow. And Paula Hammond, MIT professor and head of the Department of Chemical Engineering, said “continuous manufacturing of mRNA therapeutics has vast potential; the value of being able to quickly and safely create targeted mRNA treatments for known and not-yet-known threats is immeasurable.”

“This project is an excellent example of how chemical engineers can help to address significant needs in making the medicines of the future.”