Antibody (Ab) Advanced Manufacturing Capability Improvement: Smart Technologies

Monoclonal Antibodies (mAbs) played a central role in the US response to the outbreaks of important human pathogens such as anthrax, Ebola, RSV and SARS CoV-2. Advancing beyond the demonstrated manufacturing performance of mAbs for a rapid response, BARDA is seeking to improve (enhance) the speed and efficiency of antibody production. This effort is directed at developing and implementing FDA Advanced Manufacturing goals within the antibody manufacturing environment.

Innovations of most interest are those that rapidly scale manufacturing capabilities (scalability), create a distributed network of manufacturing sites (portability), improve cost-efficiency of manufacturing processes, and create new tools that can address drug shortages in support of the emergency preparedness and response mission of the Biomedical Advanced Research and Development Authority (BARDA).

Improvements of consideration in this solicitation apply the use of automation, digitization, and artificial intelligence to; streamline production methods, collection of more process control data, and ultimately design and deployment of smart algorithms that adaptively control or make decisions about production or release. The effort must be directed at an improvement which can be used across multiple biologics (applicability).

The effort must be focused on the manufacturing improvement of a product in the BARDA portfolio. Strategic oversight for the Project Agreement(s) supported by this RPP will be provided by BARDA.