Sep. 15, 2006 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 University of Michigan professor of chemical and biomedical engineering Henry Wang 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. This research will be also be presented at ACS in the "Economics of Biopharmaceutical Processes" session at 2 p.m. on Sept. 14. The research presented last year 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.
Currently, flu vaccines are made from hen eggs, but in light of a possible pandemic and 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 facilities.
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 said. It takes much longer to compile millions of hen eggs than it would to grow up existing cell lines from frozen vials, Lash said. 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 3 to 4 months to cover the U.S. with the system we propose," Lash said. 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, said Lash.
The expense for companies would be the cost of the downtime necessary to train personnel and to run test batches, researchers said. With research into different processes for purifying the vaccine, it would not be necessary to renovate facilities, he said.
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 said. Before there became a flu vaccine shortage, one dose cost about $1.60. Now, each dose commands $8 to $10.
This profit margin is still low compared to the profits that existing cell culture facilities can make off their protein products. Lash said 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 an pandemic.
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