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Innovative facility to produce cell-based pandemic influenza vaccine
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A new manufacturing plant in North Carolina can create influenza vaccine using cultured animal cells instead of the conventional process of using fertilized eggs, according to the Department of Health and Human Services.
The plant, which was dedicated this week in Holly Springs, N.C., is the first US facility to use a faster and more flexible technology to make influenza vaccine. The dedication signals that the FDA could authorize the facility to produce cell-based influenza vaccine during an influenza pandemic, according to a press release from HHS.
The facility is a public–private partnership of the HHS and Novartis Vaccines and Diagnostics Inc. of Cambridge, Mass. This partnership will be maintained under contract for at least 25 years.
“Today we’re marking the first change in influenza vaccine manufacturing in the United States in 50 years,” said Robin Robinson, PhD, director of the Biomedical Advanced Research and Development Authority (BARDA) in the Office of the Assistant Secretary for Preparedness and Response at HHS. “The pandemic readiness of this facility is a major milestone in national preparedness for pandemic influenza and other diseases.”
In an influenza pandemic, the new facility may be able to produce 25% of the vaccine needed in the United States. In addition, cell-based technology used in this facility for manufacturing seasonal and pandemic influenza vaccines may be adapted to produce vaccines for other known and unknown emerging infectious diseases in an emergency.
HHS and Novartis are partnering with Synthetic Genomics Vaccines of Rockville, Md., to develop new technologies to shorten the vaccine manufacturing timeline by optimizing vaccine virus seed strains used for influenza vaccine production. In addition, the agency is also working with Novartis and North Carolina State University to train international scientists to use cell culture-based manufacturing techniques similar to what is used in the new facility. The training program is part of a WHO initiative to strengthen the ability of developing countries to produce influenza vaccine, according to the HHS release.
“With the need to more rapidly produce sufficient quantities of flu vaccine on an annual basis, this could be a big step forward in future years,” Richard F. Jacobs, MD, from University of Arkansas for Medical Sciences at Arkansas Children's Hospital, said.
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