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Patricia Van Arnum was executive editor of Pharmaceutical Technology.
Novartis, GlaxoSmithKline, and Lonza are among those participating in newly formed consortiums for developing and producing medical countermeasures.
The US Department of Health and Human Services (HHS) has established three new centers to develop and manufacture medical countermeasures, such as vaccines and medicines, which can be used in health emergencies and in preparedness protection. HHS will invest $400 million in the initial phases of the centers, which include contracts to biopharmaceutical and pharmaceutical companies.
Created as public–private partnerships, the Centers for Innovation in Advanced Development and Manufacturing, will provide the first major domestic infrastructure in the United States capable of producing medical countermeasures for protection against the health impacts of bioterrorism as well as pandemic influenza and other epidemics, according to a June 18, 2012, HHS press release. The public–private partnerships will seek to engage the innovation from small biotechnology companies, training from academic institutions, and the development and manufacturing expertise of large pharmaceutical companies.
Each center will be run by a consortium led by an organization experienced in developing or manufacturing medical countermeasures. HHS will invest approximately $400 million in the initial phases of the centers, using contracts with the center leads. Overseen by the Biomedical Advanced Research and Development Authority within the HHS Office of the Assistant Secretary for Preparedness and Response, each contract can be renewed for up to 25 years. Under the contracts, each consortium will retrofit existing facilities or build new ones to incorporate flexible, innovative manufacturing platforms that can be used to manufacture more than one product. The facilities will use cell- and recombinant-based vaccine technologies that have the potential to produce vaccines for not only pandemic influenza but also other threats more quickly and in a more affordable way, according to HHS.
HHS says that the centers’ use of these technologies also will allow each to develop and manufacture a variety of products quickly enough to respond to large-scale emergencies by providing needed domestic surge capacity. Together, the centers will be capable of domestically producing a quarter of the nation’s pandemic influenza vaccine within four months of the onset of a pandemic. In 2009, only one company had manufacturing facilities solely in the US to produce H1N1 pandemic vaccine, according to HHS.
The private partners will provide approximately 35% of the total cost of the initial building phase. HHS will support the cost of operation and maintenance of the centers in subsequent years. As the facilities become operational in 2014 and 2015, the center leads will begin assisting small biotechnology companies with technology, regulatory affairs, quality systems, and manufacturing expertise to reach the goal of a licensed and readily available product for public and private use. Also at that time, center academic partners will offer advanced training for biotechnology workers.
Emergent Manufacturing Operations Baltimore LLC, with facilities in Baltimore and Gaithersburg, Maryland, will lead one center, working with a network of partners: Michigan State University; Kettering University of Flint, Michigan; and the University of Maryland in Baltimore. This contract is for approximately $163 million over the first eight years. Novartis will head a second center, leveraging existing public–private investments by HHS in its facilities in Holly Springs, North Carolina, and work with North Carolina State University and Duke University. The Novartis contract is valued at approximately $60 million over the first four years. The Texas A&M University System will lead a third center collaborating with GlaxoSmithKline Vaccines of Marietta, Pennsylvania.; Lonza of Houston, Texas, and Kalon Biotherapeutics of College Station, Texas. This contract is valued at approximately $176 million during the first five years.