Through BioMOD, DARPA seeks to develop devices and techniques to produce biologics in response to specific battlefield threats and medical needs. To that end, BioMAN plans to develop innovative methodologies for engineering robust, flexible microbial strains capable of synthesizing multiple protein-based therapeutics — as well as portable device platforms — for the rapid manufacturing of multiple biologics with high purity, efficacy and potency.
“This DARPA program aims to manufacture biologic drugs on demand in a forward-operations setting, where resources are often limited. Making drugs available within 24 hours could save lives,” says J. Christopher Love, an associate professor of chemical engineering, a member of MIT's Koch Institute for Integrative Cancer Research and lead investigator on the program.
“This timing is unheard of, as such drugs now take six to 12 months to manufacture,” he adds. “To make and release such medications on fast timescales will require orders-of-magnitude improvements on today’s manufacturing practices. The goal for BioMAN is to transform biologic drug manufacturing from a time-consuming, stepwise process to a tightly integrated one for small-scale production.”
Love suggests that the implications are tremendous: “Imagine how having rapid access to drugs in remote settings could change lives, or how such new capabilities might promote better global access to these costly drugs through distributed production.”
BioMAN is part of MIT’s Center for Biomedical Innovation (CBI), whose mission is to improve global health through the development and implementation of biomedical innovations. BioMAN focuses on developing new knowledge, science, technologies and strategies that advance the manufacture and global delivery of high-quality biopharmaceuticals.
“In BioMAN, we have created a unique ecosystem where MIT and other affiliated faculty work closely with the biomanufacturing industry, as well as government and regulatory communities, to examine key issues in biomanufacturing and see new manufacturing innovations implemented,” says Stacy Springs, BioMAN’s executive director.
Additional academic collaborators on the BioMOD program include MIT professors Richard Braatz, Jongyoon “Jay” Han, Tim Lu, Rajeev Ram, Anthony Sinskey and Michael Strano; Northeastern University professor William Hancock; and professors Steve Cramer and Pankaj Karande of Rensselaer Polytechnic Institute. GK Raju of LightPharma and CBI’s James C. Leung are both consultants on the project. Industrial collaborators include Pall Corporation and PerkinElmer. Latham BioPharm Group and the CBI will provide system integration.
“Within a two-year timeframe, we aim to have a prototype system composed of all of the individual components to make at least two different drugs at doses and qualities comparable to those that are currently on the market. We have an all-star team to meet our objectives,” says Sinskey, a professor of microbiology and faculty director of the CBI.
The two-year contract includes options that, if exercised, would bring its potential value to $21.8 million.