The Biomedical Advanced Research and Development Authority (BARDA) has identified continuous manufacturing (CM) as an emerging technology within the pharmaceutical industry that has significant potential to improve agility, flexibility, cost, and robustness in medical countermeasure manufacturing for disaster and pandemic preparedness.
BARDA’s Innovations in CM initiative was launched in 2015, focusing on the need for a national innovation policy regarding advanced manufacturing and recommendations to develop and sustain advanced manufacturing capability and capacity domestically. BARDA’s role to champion CM as a facet of advanced manufacturing has been described in the recently released Advancing Manufacturing: A Snapshot of Priority Technology Areas Across the Federal Government (2016) by the Obama administration.
Although the continuous input of active pharmaceutical ingredient in the manufacturing of small-molecule drug products has been met with some success, as has the production of biological products (e.g. monoclonal antibodies) by means of continuous perfusion bioreactors, “true” end-to-end continuous manufacturing from raw materials and reagents to drug product at a commercial scale has not yet been realized.
BARDA research and development goals are currently designed to advance continuous manufacturing beyond what is feasible today and facilitate the industry-wide adoption of this emerging technology.
Future BARDA investments will focus on the application of innovative CM technologies directly into advanced product development processes for BARDA-priority medical countermeasures, demonstrating their return-on-investment required for mainstream adoption.
BARDA’s current funding mechanism for this development process is the Broad Ageny Announcement (BAA) for the Advanced Development of Medical Countermeasures for Pandemic Influenza (BAA-16-100-SOL-00002). The BAA remains open for proposals until Oct 30, 2017.
BARDA is interested in proposals addressing translational science; specifically: the transition of novel technology from academia and Industry to pharmaceutical companies, integration of innovative CM technologies into current process development activities, or demonstration of a phase 3 commercial process proof-of-concept utilizing CM technologies.
BARDA is part of the Department of Health and Human Services, Office of the Secretary, Assistant Secretary for Preparedness and Response.