Day: February 15, 2024

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<p class=”text-body text-muted small”>US Army Medevac UH-60L Black Hawk seen at Kandahar Airfield. DARPA is exploring new ways to produce battlefield medicines at front-line bases and outposts. (Janes/Patrick Allen)</p>
<p>A new Defense Advanced Research Projects Agency (DARPA) programme aims to accelerate drug manufacturing in austere environments, such as forward operating bases (FOBs), generating data and processes to evaluate new paradigms for real-time regulatory approval.</p>
<p>Launched in January 2024 the aim of the Establishing Qualification Processes for Agile Pharmaceutical Manufacturing (EQUIP-A-Pharma) programme is to “demonstrate a real-time digital regulatory approval framework for multiple finished drug products produced on a single reprogrammable hardware platform”, according to the agency.</p>
<p>The programme aims to bridge the gap between technology and the current regulatory framework. Advances in machine-learning (ML) models, manufacturing hardware, and synthetic chemistry mean that drug products can be rapidly synthesised and produced at FOBs and similar austere environments, DARPA noted in its announcement of the programme.</p>
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Such technology uses a chemical synthesis hardware platform, which produces drug products, active pharmaceutical ingredients (APIs),
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and so on. Essentially, a user with only limited knowledge of synthetic chemistry could input a particular target through software, and the hardware will manufacture the required drug product, according to DARPA.
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<p>EQUIP-A-Pharma will leverage new manufacturing technology that can process data to inform the creation of a real-time regulatory approval process, which is currently lacking. The lack of data for a real-time approval process has hampered new private capital investment to further develop point-of-need drug manufacturing.</p>
<p>EQUIP-A-Pharma aims to address this challenge by demonstrating a real-time digital regulatory approval framework for multiple drug products produced with a single, reprogrammable hardware platform, according to DARPA. It aims to develop four pharmaceutical manufacturing sites to produce data that could inform a future regulatory framework.</p>