Establishing Qualification Processes for Agile Pharmaceutical Manufacturing (EQUIP-A-Pharma)

Background
The Defense Advanced Research Projects Agency (DARPA) is soliciting innovative approaches to address challenges in qualifying drug products produced in an agile pharmaceutical manufacturing platform. EQUIP-A-Pharma will aim to develop the technology and process models to demonstrate real-time qualification of multiple drug products produced by reprogramming or reconfiguring the manufacturing platform and inform the creation of a future regulatory framework for agile pharmaceutical manufacturing.

Work Details
The solicitation outlines the acquisition process, including submission of abstracts, oral presentations, and subsequent phases. The program aims to bring together experts in agile pharmaceutical manufacturing, process informatics, data science, and the business community to commercialize automated chemical synthesis of pharmaceuticals. The program goals include identifying MVPs that can be manufactured on the same hardware, designing and fabricating manufacturing hardware with in-process metrology, and producing MVPs and real-time product quality assessment through process informatics models.

The program also aims to support up to four manufacturing sites to inform the creation of a future regulatory framework. The program tasks and deliverables are detailed in Table 2, including MVP identification report, requirements and feasibility identification, manufacturing feasibility report, procurement report, quality analysis & regulatory filing, informatics models, and correlation report.

Period of Performance
The period of performance includes a Phase 1 with a 6-month duration for creating MVP requirements and manufacturing feasibility designs. Phase 2 is notionally 12 months long, followed by Phase 3 notionally lasting 6 months. The timeline for tasks and milestones is detailed in Figure 1 and Table 2.

Place of Performance
The geographic locations for contract performance are not explicitly provided in the solicitation.