Battelle and Aprecia have been awarded a U.S. Defense Advanced Research Projects Agency (DARPA) agreement to advance the research program titled Establishing Qualification Processes for Agile Pharmaceutical Manufacturing (EQUIP-A-Pharma) through funding from the U.S. Department of Health and Human Services (HHS) Administration for Strategic Preparedness and Response (ASPR) Office of Industrial Base Management and Supply Chain (IBMSC). ASPR's mission is to assist in preparing for, responding to, and recovering from public health emergencies and disasters. The EQUIP-A-Pharma research program will investigate how a custom small-scale chemical synthesis platform, built by Battelle, combined with Aprecia's revolutionary 3D printing technology can accelerate U.S. drug production to deliver high quality, sustainable medications, initially focusing on two medications categorized as essential medicines for the US population.
The EQUIP-A-Pharma program will create agile pharmaceutical manufacturing sites producing both active pharmaceutical ingredients and the finished pharmaceutical dosage forms at the same location, significantly shortening the pharmaceutical raw material supply chain while also lessening supply chain risk for commercial product distribution. The synthesis platform being built by Battelle is specifically designed to be able to synthesize multiple active pharmaceutical agents while meeting all regulatory requirements for production of these drugs. Aprecia's Z-Form Flex technology platform is designed for agile manufacturing applications as it produces finished tablets directly in the primary packaging, enabling integrated aspects of manufacturing and packaging operations. This technology platform is also structured to rapidly accommodate drug product formulation modifications to help meet the needs of medications for diverse patient populations.
"We are optimistic that the EQUIP-A-Pharma research program will help identify pathways that will bring agile pharmaceutical manufacturing technology to the masses," said Greg Kimmel, general manager, health unit, at Battelle. "Agile pharmaceutical manufacturing technology is a game-changer, and this program will help us bring to life its benefits including, enabling point-of-need manufacturing for military operations, addressing public health emergencies, like drug shortages, and serving as a foundational tool for personalized medicine."
The EQUIP-A-Pharma program will generate key scientific data needed to demonstrate that agile manufacturing can meet FDA drug product registration requirements and be utilized to produce safe and effective pharmaceutical products. In addition, it will facilitate broader adoption of advanced manufacturing technology, such as the Aprecia 3D printing technology, unlock private capital for commercialization of innovative pharmaceutical technology, and propel the agile pharmaceutical manufacturing technology into the marketplace.
"The EQUIP-A-Pharma program provides a critical opportunity to collaborate with public health stakeholders on agile pharmaceutical manufacturing utilizing our 3D printing technology," said Kyle Smith, president and chief operating officer at Aprecia. "By collaborating with Battelle and DARPA, we will focus on creating a pathway that ensures Aprecia's innovative manufacturing processes address unmet medical needs. This commitment will deliver safe and effective medications more efficiently to those who need them most, including military personnel."
The potential impact of this work is far reaching. Through this innovative program and with directional support from the Industrial Base Management and Supply Chain (IBMSC), Battelle and Aprecia will use agile pharmaceutical manufacturing technology to address critical drug shortages more rapidly, enable point-of-need manufacturing to support military operations and medical countermeasure applications, enhance the overall resilience of the pharmaceutical supply chain and develop the foundation for more personalized medicine success.
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