The review found that many developers of medical countermeasures for biothreats were inexperienced in the complete lifecycle of complex countermeasure development, manufacturing and licensing. Additionally, many smaller companies were unable to afford the capital investments to build and operate commercial scale manufacturing plants to produce these products.
ASPR/BARDA and the Department of Defense sought input in 2010 from the pharmaceutical and the biotech industry on how to remove barriers to innovation and build more robust public – private partnerships in medical countermeasure development and manufacturing.
The partnerships would provide assistance with advanced development and manufacturing core services to small biotech firms by large pharmaceutical companies. The core services provided in advanced development include assistance to scale-up manufacturing processes (from lab bench and pilot scale to commercial scale) and to optimize and validate upstream and downstream manufacturing processes, product formulation, packaging and labeling, lot release assays, clinical sample assays for efficacy, and storage and shipping. The core services provided in manufacturing include pilot lot manufacturing of clinical investigational products and commercial scale manufacturing of product for stockpiling or response.
Based on successful public-private partnerships between BARDA and industry partners to manufacture pandemic influenza vaccines in retrofitted and new facilities using classic and new vaccine technologies, additional partnerships could be established to provide vaccines or biological products such as antibodies and recombinant proteins, against pandemic influenza or other threats in an emergency.
With this extensive feedback and experiences on public-private partnerships, BARDA issued a request for proposals in March 2011 to establish multiple Centers for Innovation in Advanced Development and Manufacturing. These centers will provide on a routine basis core services to assist companies developing vaccines and biological biodefense products with advanced development and manufacturing. In an emergency, these centers will produce vaccines and biological drugs against pandemic influenza and other threats using innovative and flexible manufacturing processes coupled with state-of-the-art recombinant and molecular vaccine technologies.
The federal government will pay part of the cost of retrofitting facilities or building new ones to manufacturing medical countermeasures and to develop new, innovative products to protect the nation from threats. BARDA has received multiple proposals in July 2011 from private industry and academic consortia, and contract awards are expected in 2012.