The U.S. Department of Health and Human Services has established a fill and finish manufacturing network as part of an effort to manufacture flu vaccine quickly in a pandemic. The network supplements national manufacturing capacity by 20%. HHS awarded contracts to four U.S. companies valued at approximately $39.8 million, and include Cook Pharmica of Bloomington, IN, JHP Pharmaceuticals of Parsippany, NJ, DSM Pharmaceuticals of Greenville, NC, and Nanotherapeutics of Alachua, FL. The new network is in response to 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.
“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 companies will collaborate with HHS Centers for Innovation in Advanced Development and Manufacturing, established in 2012, and with domestic flu vaccine manufacturers to provide services for the production of clinical investigational lots of medical countermeasures that are in development. Each company in the network will partner with a vaccine manufacturer to transfer the fill and finish technology into its existing facilities to provide surge capacity for pandemic response. The manufacturing network may also provide these services for manufacturers of drugs and vaccines intended to protect public health against chemical, biological, radiological and nuclear threats.
HHS Establishes Flu Vax Manufacturing Network
Published October 1, 2013
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