New fill and finish manufacturing network strengthens pandemic readiness
To boost the nation’s ability to manufacture influenza vaccine quickly in a pandemic, the U.S. Department of Health and Human Services today established a fill and finish manufacturing network, which will cover the final steps in the vaccine manufacturing process. Led by HHS, the network supplements the capacity that influenza vaccine manufacturers currently have, potentially increasing national capacity to produce influenza vaccine by 20 percent.
The Biomedical Advanced Research and Development Authority (BARDA), in HHS’ Office of the Assistant Secretary for Preparedness and Response, awarded contracts to four U.S. companies that will make up the network. Today’s contracts, totaling approximately $39.8 million, are awarded to Cook Pharmica of Bloomington, Ind., JHP Pharmaceuticals of Parsippany, N.J., DSM Pharmaceuticals, Inc. of Greenville, N.C., and Nanotherapeutics of Alachua, Fla.
“No longer will fill and finish manufacturing be the limiting factor in making pandemic influenza vaccines or other products available in a public health emergency,” said BARDA Director Robin Robinson, Ph.D. “The fill and finish manufacturing network will be an integral part of other national assets that address the need for timely manufacturing of medical countermeasures to respond to man-made and natural threats.”
The new network responds to a recommendation proposed by the Public Health Medical Countermeasure Enterprise Review (2010) to create a network of existing, pre-qualified facilities that could fill and finish vaccine for manufacturers in a public health emergency.
As a network, these companies will collaborate with the three HHS Centers for Innovation in Advanced Development and Manufacturing, established in 2012, and with domestic influenza vaccine manufacturers. In addition the network will provide its services to HHS for production of clinical investigational lots of medical countermeasures that are in development.
Each company in the network will partner with a pandemic influenza vaccine manufacturer to transfer the fill and finish technology into its existing facilities to provide surge capacity for pandemic response. The expanded fill and finish manufacturing network also could provide these core services for manufacturers of drugs and vaccines intended to protect public health against chemical, biological, radiological and nuclear threats.
The network builds on BARDA’s public-private partnership model to provide a coordinated national medical countermeasure manufacturing infrastructure and exemplifies BARDA’s core service assistance approach towards a comprehensive, integrated plan for advanced research and development, innovation, acquisition, and manufacturing of vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiological, and nuclear agents, pandemic influenza, and emerging infectious diseases.
HHS is the principal federal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. ASPR leads HHS in preparing the nation to respond to and recover from adverse health effects of emergencies, supporting communities’ ability to withstand adversity, strengthening health and response systems, and enhancing national health security.