Industry trade groups, including the Alliance for Regenerative Medicine (ARM), Biotechnology Industry Organization (BIO), and Pharmaceutical Research and Manufacturers of America (PhRMA), have provided comments and suggestions for the FDA’s draft strategy on the use of innovative manufacturing technologies.
In September, the FDA unveiled a draft strategy aimed at promoting innovative manufacturing technologies for drugs and biologics, a move that could reshape production processes for biopharma companies.
Developed under the Prescription Drug User Fee Act (PDUFA VII) for fiscal years 2023–2027, the strategy outlines steps to address barriers to adoption and improve regulatory support for advanced manufacturing methods such as continuous manufacturing, distributed manufacturing, and artificial intelligence (AI) applications.
The draft document stems from the FDA’s commitment to fostering innovation in manufacturing processes to enhance supply chain resilience, reduce production costs, and mitigate drug shortages. It builds on insights gathered during a public workshop hosted by the Duke-Margolis Center for Health Policy in June 2023, where regulators and industry leaders discussed the challenges and opportunities associated with advanced manufacturing.
Central to the strategy is the expansion of FDA’s Emerging Technology Program (ETP) and Advanced Technology Teams (CATT), which provide regulatory guidance to companies integrating cutting-edge manufacturing methods. The strategy also introduces the Advanced Manufacturing Technology (AMT) designation program, designed to offer targeted support for promising innovations.
However, biopharma stakeholders have pointed out areas for improvement. ARM, BIO and PhRMA have urged the FDA to include clearer timelines for program applications and provide more guidance on how technologies such as AI and machine learning (ML) can be incorporated into manufacturing.
ARM, which represents the cell and gene therapy (CGT) industry, asked the regulator to provide additional detail in the draft strategy on the scope of technologies eligible for the innovative designation “by offering considerations for what constitutes substantial improvement by a novel manufacturing process, e.g., whether the use of novel computational methods (AI/ML models) to optimize CGT vectors (payload, capsid, cell lines) would be considered a substantial improvement.”
While the FDA draft mentions distributed manufacturing, other priority areas identified by the regulator’s Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) are notably absent.
Another critical aspect of the draft strategy is its emphasis on international collaboration. Industry groups highlighted the need for the FDA to align regulatory standards with global counterparts, such as the European Medicines Agency, to facilitate broader acceptance of advanced manufacturing. Suggestions include sharing best practices and creating joint guidance on technologies that could benefit from international harmonization.