Battelle, a worldwide analysis and growth group, and Aprecia, a pharmaceutical manufacturing firm, have been awarded a US Protection Superior Analysis Initiatives Company (DARPA) settlement to advance the Establishing Qualification Processes for Agile Pharmaceutical Manufacturing (EQUIP-A-Pharma) program. The initiative is funded by the US Division of Well being and Human Providers (HHS) Administration for Strategic Preparedness and Response (ASPR) Workplace of Industrial Base Administration and Provide Chain (IBMSC), whose mission is to arrange for, reply to, and get well from public well being emergencies and disasters.
The EQUIP-A-Pharma program explores how Battelle’s customized small-scale chemical synthesis platform, mixed with Aprecia’s 3D printing know-how, can speed up US drug manufacturing and ship sustainable, high-quality medicines. The undertaking will initially concentrate on two important medicines.
This system’s purpose is to determine agile manufacturing websites that may produce each lively pharmaceutical elements (APIs) and completed dosage kinds on the identical location. This method shortens provide chains and reduces distribution danger. Battelle’s synthesis platform is engineered to synthesize a number of APIs whereas assembly regulatory requirements. Aprecia’s Z-Kind Flex know-how produces completed tablets immediately in major packaging, integrates packaging with manufacturing, and permits fast formulation modifications to serve numerous affected person wants.
“We’re optimistic that the EQUIP-A-Pharma analysis program will assist establish pathways that may convey agile pharmaceutical manufacturing know-how to the lots,” stated Greg Kimmel, Basic Supervisor of the Well being Unit at Battelle. “Agile pharmaceutical manufacturing know-how is a game-changer, and this program will assist us convey to life its advantages, together with, enabling point-of-need manufacturing for navy operations, addressing public well being emergencies, like drug shortages, and serving as a foundational device for customized drugs.”
This system will generate knowledge to indicate that agile manufacturing can meet FDA registration necessities and produce protected, efficient prescribed drugs. It additionally goals to speed up the adoption of superior applied sciences like Aprecia’s 3D printing, appeal to personal funding, and broaden commercialization alternatives.
“The EQUIP-A-Pharma program supplies a crucial alternative to collaborate with public well being stakeholders on agile pharmaceutical manufacturing using our 3D printing know-how,” stated Kyle Smith, President and Chief Working Officer at Aprecia. “By collaborating with Battelle and DARPA, we are going to concentrate on making a pathway that ensures Aprecia’s revolutionary manufacturing processes handle unmet medical wants. This dedication will ship protected and efficient medicines extra effectively to those that want them most, together with navy personnel.”
With IBMSC assist, Battelle and Aprecia purpose to deal with drug shortages quicker, allow navy point-of-need manufacturing, strengthen provide chain resilience, and lay the groundwork for customized drugs.