HHS and Novartis Dedicate First Cell-Based Flu Vaccine Plant in US

Dec 22, 2011

Last week, the US Department of Health and Human Services (HHS) and Novartis Vaccines and Diagnostics dedicated a manufacturing plant that can create influenza vaccine using cultured animal cells instead of the conventional expression system of fertilized eggs. The facility, located in Holly Springs, North Carolina, is the first in the United States to use this technology, which HHS called “faster and more flexible” in a press statement.

HHS and Novartis dedicated the plant as part of an initiative to provide vaccine supplies, which could be authorized by FDA, rapidly during an influenza pandemic. The facility is a public–private partnership that HHS and Novartis will maintain under contract for at least 25 years.

During a flu pandemic, the Holly Springs facility may be able to produce 25% of the vaccine needed in the United States. In an emergency, the cell-based technology that the facility uses may be adapted to produce vaccines for other known and unknown emerging infectious diseases. Several European countries already have the capability to manufacture cell-based influenza vaccines on a large scale.

“Today we’re marking the first change in influenza vaccine manufacturing in the United States in 50 years,” said Robin Robinson, director of the Biomedical Advanced Research and Development Authority (BARDA) in HHS’s Office of the Assistant Secretary for Preparedness and Response, in the statement. Robinson led the effort for HHS. “The pandemic readiness of this facility is a major milestone in national preparedness for pandemic influenza and other diseases,” Robinson added.

Two reports published in August 2010 recommended investing in new vaccine technology to reduce the time needed to produce pandemic vaccine and increase the nation’s surge capacity. One was
Public Health Emergency Medical Countermeasures Enterprise Review” by HHS Secretary Kathleen Sebelius. The other was “Report to the President on Reengineering the Influenza Vaccine Production Enterprise to Meet the Challenges of Pandemic Influenza” by the President's Council of Advisors on Science and Technology.

Novartis is collaborating with HHS on several other projects as well. The two organizations, together with Synthetic Genomics Vaccines of Rockville, Maryland, are developing new technologies to shorten the time required to manufacture vaccines by optimizing vaccine-virus seed strains used for flu-vaccine production. BARDA and Novartis are working with North Carolina State University to train international scientists to use cell-culture-based manufacturing techniques similar to those used in the new facility. The training program is part of a World Health Organization initiative to strengthen developing countries’ ability to produce flu vaccine.

See related Pharm Tech articles:

HHS Recommends Ways to Improve US Efforts in Medical and Vaccine Preparedness (ePT)

Presidential Advisory Council Says Vaccine Production for Pandemic Preparedness Needs to Be Improved (ePT)

Global Health Challenges Spur Vaccine Development (Pharm Tech)

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