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EQUIP-A-Pharma: Establishing Qualification Processes for Agile Pharmaceutical Manufacturing

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).

 

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