Summary
DARPA’s new Establishing Qualification Processes for Agile Pharmaceutical Manufacturing (EQUIP-A-Pharma) program seeks to demonstrate a real-time digital regulatory approval framework for multiple finished drug products produced on a single reprogrammable hardware platform.
The program aims to support up to four pilot agile pharmaceutical manufacturing sites that will generate the data required to inform the creation of a future regulatory framework.
Agile pharmaceutical manufacturing refers to a suite of chemical synthesis hardware and software that can be rapidly reconfigured or reprogrammed to produce finished drug products from widely available starting chemicals (commodity chemicals or precursors).
The EQUIP-A-Pharma is managed in collaboration with the Administration of Strategic Preparedness and Response (ASPR) Division in Health and Human Services (HHS).