C-SOPS to Lead Multi-Institutional DARPA-Funded EQUIP-A-Pharma Project
Project’s Phase 1 to determine feasibility of proposed mobile system for manufacturing injectables
Fernando Muzzio, distinguished professor in the Department of Chemical and Biochemical Engineering and Center for Structured Organic Particulate Systems (C-SOPS) director, has received a $500,000 EQUIP-A-Pharma program award from the Defense Advanced Research Projects Agency, or DARPA, for Phase 1 of its project, “Mobile system for GMP manufacturing of injectable products.”
“DARPA is a major research agency spanning a myriad of strategic research areas and technologies,” says Marcelo Meragalli Ferrer, C-SOPS assistant director for industry relations. “The EQUIP-A-Pharma program involves important federal agencies like ASPR, or the Administration for Strategic Preparedness and Response, through its Office of Industrial Base Management and Supply Chain.”
A Potential Game-Changer
Through EQUIP-A-Pharma, DARPA seeks to demonstrate real-time quality control for flexible manufacturing systems and generate the necessary support data to prompt FDA to consider new regulatory frameworks for adopting and commercializing agile manufacturing technologies. By enabling point-of-need drug manufacturing, Muzzio, whose research has focused on pharmaceutical product and process design since he joined Rutgers Engineering in 1991, sees the EQUIP program as “a potential game-changer in a highly regulated sector without specific guidance for this kind of systems yet. Its success could help address drug shortages – a major concern among government and health care providers nationally – and improve patients’ access to medicines, including personalized drugs.”
Muzzio adds, “While not the first time that C-SOPS has been involved in a DARPA project, it is its first time as a lead institution.” For this project, the C-SOPS team is partnering with Virginia Commonwealth University, a leader in the field of API synthesis; CMIC CMO USA, a contract manufacturer; and Occam Systems, a start-up company dedicated to model-based sourcing and systems engineering.
A Six-Month Feasibility Analysis
The proposal led by Muzzio involves developing a mobile system for good manufacturing practices (GMP) in the manufacture of injectable pharmaceutical products. Phase 1 consists of a six-month feasibility analysis with three milestones, plus a final report, which will then determine project eligibility for Phases 2 and 3.
“Being selected even for Phase 1 is in itself an acknowledgement of C-SOPS’s trajectory in terms of capabilities, accomplishments, and future-thinking innovation,” says Muzzio. “Our group is the only university-led team among the selected proposers, meaning that DARPA trusts us as an academic institution to deliver results like industry does.”
“Finally, our selection is a recognition of C-SOPS’s expertise in continuous manufacturing methods beyond those for oral solid dose medicines that made it famous in the first place, as well as for the center’s ability to apply its knowledge to other areas.”
