Wang and Lash first did a case study of traditional vaccine manufacturing, where the virus is injected and incubated in a chicken egg, killed and extracted, then bottled and sold. The process takes more than four months.
Next, the researchers considered the cell-based vaccines. In the cell culture approach, the flu virus incubates in cell cultures rather than in eggs. Several companies are trying to perfect the cell-based flu vaccines where cells are grown in large vats. It is seen as a promising approach because it's more flexible and quicker than the current egg culture method.
By building a separate cell culture facility and shipping the cell to the existing biomanufacturing plants (assuming they have agreed in advance to participate), the production cycle could be cut in half to two months, Wang said.
Lash and Wang identified approximately a dozen potential facilities around the world that are large scale FDA and GMP (good manufacturing practices) approved facilities that could potentially be modified to manufacture flu vaccines in an emergency.
Many biopharmaceutical facilities use mammalian cell culture already to produce their drug products so they could easily be switched to producing flu vaccine using the same bioreactors, the researchers argue. Long term, it might be necessary to standardize the production systems at facilities in the network to ensure consistency in the vaccine manufacturing process.
An influenza emergency is nearly inevitable, experts say. All the factors exist for a major flu pandemic: new, extremely aggressive viruses with new ways of spreading, and insufficient vaccine supplies. A Jan. 24 flu symposium hosted by the U-M School of Public Health's Michigan Center for Public Health Preparedness and the Michigan Department of Community Health discussed this threat in-depth. Visit: http://www.umich.edu/news/index.html?Releases/2005/Feb05/flu
To reduce the time required to expand the cells to production scale, a small GMP cell culture facility could maintain the cells and expand in the face of a crisis, ready to provide them as seeds to the facilities that will help manufacture the vaccine, Lash said.
"We feel that this facility would work well as part of a university or training center that could be operated by students gaining valuable experience in biopharmaceutical manufacturing, and keep us prepared to respond to an emergency," Lash said.
Funding to build this facility and set up this network could come from the government or companies that are willing to be a part of the network, Lash said.
"There are several scientific and regulatory issues to manufacturing the vaccine using this network concept so we will apply for funding to address the scientific issues to enable such a facility and network to be built in the future," Lash said.
Economically, the use of cell culture to produce the vaccine is comparable to that of egg culture. It is more expensive to build a new large cell culture facility to produce the vaccine than a new egg culture facility so the use of existing cell culture facilities would be advantageous.
The next step is to continue research to identify and address the technical issues, such as ensuring consistent good growth of cells shipped for different times to different facilities, and ensuring that the cells are not contaminated.
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