BioMAN investigators plan to develop portable device platforms and new ways to engineer flexible microbial strains capable of synthesizing multiple protein-based therapeutics.
“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 $21.8m.
The rapid manufacturing of biologics “within 24 hours could save lives,” said J. Christopher Love, an associate professor of chemical engineering at MIT.
“This timing is unheard of, as such drugs now take six to 12 months to manufacture,” Love said. “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.”
BioMAN research is currently looking into high-throughput, single cell screening platforms for the phenotypic profiling of 105 – 106 cells per assay. They are also evaluating polyclonal populations of cells used in biomanufacturing for rates of production, antigen specificity and native structure, as well as variation in glycosylation.
The goal of the initial BioMAN research is to develop new sensors, assays and technologies to understand how critical parameters such as host cell line or process conditions affect quality and productivity of therapeutic production, as well as how these parameters impact biological activity and safety.
BioMAN works closely with the biomanufacturing industry, “as well as government and regulatory communities, to examine key issues in biomanufacturing and see new manufacturing innovations implemented,” Stacy Springs, BioMAN’s executive director, said.
Industrial collaborators include Pall Corporation and PerkinElmer. Latham BioPharm Group and the CBI will provide system integration on DARPA’s Biologically-derived Medicines On Demand (BioMOD) program.