Battelle, a world analysis and growth group, and Aprecia, a pharmaceutical manufacturing firm, have been awarded a US Protection Superior Analysis Tasks 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 Companies (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 better 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 expertise, can speed up US drug manufacturing and ship sustainable, high-quality drugs. The venture will initially deal with two important medicines.
This system’s aim is to ascertain agile manufacturing websites that may produce each energetic pharmaceutical substances (APIs) and completed dosage types on the similar location. This method shortens provide chains and reduces distribution threat. Battelle’s synthesis platform is engineered to synthesize a number of APIs whereas assembly regulatory requirements. Aprecia’s Z-Type Flex expertise produces completed tablets straight in main packaging, integrates packaging with manufacturing, and permits fast formulation adjustments to serve various affected person wants.
“We’re optimistic that the EQUIP-A-Pharma analysis program will assist establish pathways that can deliver agile pharmaceutical manufacturing expertise to the plenty,” stated Greg Kimmel, Common Supervisor of the Well being Unit at Battelle. “Agile pharmaceutical manufacturing expertise is a game-changer, and this program will assist us deliver to life its advantages, together with, enabling point-of-need manufacturing for army operations, addressing public well being emergencies, like drug shortages, and serving as a foundational instrument 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, entice non-public funding, and increase commercialization alternatives.
“The EQUIP-A-Pharma program offers a vital alternative to collaborate with public well being stakeholders on agile pharmaceutical manufacturing using our 3D printing expertise,” stated Kyle Smith, President and Chief Working Officer at Aprecia. “By collaborating with Battelle and DARPA, we’ll deal with making a pathway that ensures Aprecia’s progressive manufacturing processes tackle unmet medical wants. This dedication will ship protected and efficient drugs extra effectively to those that want them most, together with army personnel.”
With IBMSC assist, Battelle and Aprecia intention to handle drug shortages sooner, allow army point-of-need manufacturing, strengthen provide chain resilience, and lay the groundwork for customized drugs.
