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Updated 10:00 AM Sept. 25, 2006
 

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  Research
Existing vaccine facilities can handle flu pandemic

The most cost effective and quickest way to respond to a flu pandemic within the next five years is to use existing facilities to make vaccines from cell cultures, new research suggests.

In a study led by Henry Wang, professor of chemical and biomedical engineering, and doctoral student Lyle Lash, researchers examined the economics of producing egg versus cell culture vaccines in the event of a flu pandemic. They found that training personnel to make cell culture vaccines in existing facilities is the only way to make enough doses to cover the United States in a short time without requiring huge capital investments to build new dedicated flu vaccine cell culture facilities.

The study builds upon research presented last year at the American Chemical Society National Meeting, which also was presented at ACS in the "Economics of Biopharmaceutical Processes" session Sept. 14. The research focused on how the use of existing cell culture facilities and other vaccine development and manufacturing changes can cut down the time to respond to a pandemic.

Flu vaccines currently are made from hen eggs, but in light of a possible pandemic, and with ongoing shortages even during normal flu season, the government and private corporations have been scrambling for new and faster ways to make a flu vaccine. Some options include building new and bigger facilities or to retrofit existing ones.

The reasons to shift from egg to cell culture production are time and capacity, both of which are critical factors in responding to a pandemic, researchers say. It takes much longer to compile millions of hen eggs than it would to grow up existing cell lines from frozen vials, Lash says. While cell culture has a lower yield than egg culture, there is more existing capacity for cell culture than for inoculating and processing eggs.

"Based on existing dosages, we'd have enough doses in about three to four months to cover the United States with the system we propose," Lash says. Currently, it would take six months to make 250 to 300 million doses of pandemic flu vaccine for the United States. "What we're proposing could make 600 million doses in four months."

There are about 15 facilities in the country that make protein products from mammalian cell cultures where personnel could be trained to make flu vaccines using cell cultures, Lash says.

The expense for companies would be the cost of the downtime necessary to train personnel and to run test batches, researchers say. With research into different processes for purifying the vaccine, it would not be necessary to renovate facilities, he says. Many companies have been investing in developing cell culture flu vaccines due to government funding and the increase in price of the seasonal flu vaccine, Lash says. Before there became a flu vaccine shortage, one dose cost about $1.60. Now, each dose commands $8-$10.

This profit margin still is low compared to the profits that existing cell-culture facilities can make off their protein products. Lash says for the plan to work there must be some type of government funding to subsidize companies for lost production time due to training staff. Researchers envision a sort of National Guard approach, with staff trained and on standby to respond to a pandemic.

For more on Wang, go to www.engin.umich.edu/dept/cheme/people/wang.html.

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