NEWARK, Del., November 12, 2024 — The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) has published an action plan for increasing flexibility of antibody manufacturing for rapid response.
Antibody therapies provide life-saving treatment for patients facing a wide variety of medical conditions, from cancers and autoimmune disorders to infectious diseases like COVID-19. Antibody therapy manufacturers need increased flexibility to be able to rapidly develop new products for use in emergency health situations while maintaining supplies of existing ones for the patients who need them.
Next-generation technologies would allow these manufacturers to more rapidly scale up production, increase the speed at which their products get to market, and diversify their portfolios to target multiple diseases and variants. However, challenges remain with enabling the biopharmaceutical industry to adopt these technologies.
To explore these challenges and potential ways to address them, NIIMBL sought input from biopharmaceutical manufacturing industry experts among its membership via interviews, a survey, and three virtual workshops. This content was developed into the action plan, which describes the need and value for increased adoption of next-generation technology for this industry, the barriers currently limiting flexible and rapid manufacturing processes, and a set of priority actions that NIIMBL can pursue alongside the U.S. government toward addressing the barriers.
“Over the last year or two, we’ve seen an increase in conversations around how we can move medical countermeasures to commercial manufacturing as quickly as possible,” said NIIMBL Institute Director Kelvin Lee. “NIIMBL plays a role in facilitating these conversations and developing solutions, including the innovative technologies being demonstrated in our testbeds. For this plan, we wanted to put our heads together and determine what the current state is and what activities we need to pursue. This plan shows what the future of rapid response antibody manufacturing capability could be.”
Moving forward, NIIMBL will pursue high-priority activities in the plan through the work done in its NIIMBL-Led Programs and by soliciting ideas for new projects through its Project Call Program. Industry stakeholders who are interested in contributing to these solutions are encouraged to check out NIIMBL membership.
To download the Action Plan, visit niimbl.org.
About NIIMBL
The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) is a public-private partnership whose mission is to accelerate biopharmaceutical innovation, support the development of standards that enable more efficient and rapid manufacturing capabilities, and educate and train a world-leading biopharmaceutical manufacturing workforce, fundamentally advancing U.S. competitiveness in this industry. NIIMBL is part of Manufacturing USA®, a diverse network of federally sponsored manufacturing innovation institutes, and is funded through a cooperative agreement with the National Institute of Standards and Technology (NIST) in the U.S. Department of Commerce with significant additional support from its members.
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