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New vaccine process proposed; Chemical, not biological method is fast.

Byline: Lisa Eckelbecker

The following correction was published in the Telegram & Gazette on June 25, 2009:

The federal government awarded a contract to CSL Biotherapies to supply H1N1 influenza vaccine material. Because of a reporter's error, the company's name was incorrect in Tuesday's Telegram & Gazette.

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WORCESTER - Traditionally, you've had to crack a few eggs to make a vaccine - or a few million eggs.

But as world health officials track the spread of the H1N1 swine influenza virus across the globe and order up stocks of material that may be used for vaccines later this year, a Worcester biotechnology company is among companies arguing there might be a better way than hen eggs or even newer cell systems to make vaccines.

Antigen Express Inc. is mobilizing to find money and opportunities to show that its technology, which strings together peptides, could rapidly lead to safe, effective flu vaccines.

"It's not a biological process, it's a chemical process," said Douglas M. Powell, director of immunobiology at Antigen Express, a six-person subsidiary of Toronto-based Generex Biotechnology Corp. "It's not futuristic, it's here now."

The traditional method of influenza vaccine development and production starts with hen eggs. Workers inject a virus into eggs, where the virus replicates. Later, the virus can be removed from the eggs and used in vaccines.

The process is effective but requires millions of eggs, and it can take months to produce enough material for seasonal flu vaccines. In recent years, cell-culture systems have evolved to accomplish a similar thing in large, sterile production facilities. Workers use batches of cells from mammals, yeast or even insects to grow components for vaccines.

The Antigen Express approach takes vaccine development in a different direction by using laboratory machines to string together amino acids into peptides, short bits of proteins designed to stimulate the body's production of immune cells against specific threats, such as influenza. The process results in a dry powder that can be stored and later mixed with fluid to create vaccine doses, Mr. Powell said.

There are no peptide vaccines approved for use in the United States, but Antigen Express has been testing peptides against H5N1 avian influenza in Lebanon and has reported that early tests showed the treatments were safe and well-tolerated.

The World Health Organization recently raised its pandemic alert level for H1N1 to level six, the highest level, indicating the widespread nature of the virus. WHO considers the pandemic "moderate," meaning that most people recover from infection without medical care or hospitalization.

Last month, the U.S. Department of Health and Human Services awarded about $1 billion to five companies - Novartis AG, GlaxoSmithKline plc, Sanofi Pasteur, CSL Biotherapeutics (SEE PUBLISHED CORRECTION) and MedImmune Inc. - to produce antigen and adjuvant for a possible H1N1 vaccine. An antigen is the active protein that stimulates a patient's immune system, and adjuvants boost the power of vaccines.

The government wants to see results from human studies of a vaccine by the end of the summer, said Bill Hall, an HHS spokesman. With those results and information on H1N1 trends, the government could decide whether to launch a vaccination campaign ahead of the winter cold and flu season.

"Having a vaccine doesn't mean you do a vaccination campaign, but you can't do a vaccination campaign without vaccine," Mr. Hall said.

Some of the companies have reported they are using cell systems to churn out material. None of the $1 billion is going to newer, more experimental vaccine technologies.

Yet companies other than Antigen Express are pushing ahead with new vaccine work. Replikins Ltd. of Boston recently reported it has developed a peptide vaccine against H1N1 and is seeking a partner for testing. VaxInnate Corp. of Cranbury, N.J., said last week it developed a fusion-protein vaccine against swine flu in less than three weeks and tested it in mice, with positive results. VaxInnate inserts genes for two key proteins into E. coli bacteria, prompting the bacteria to churn out the fusion protein that goes into its vaccine.

Traditional methods of generating flu vaccines rely on past information and months-long production processes, according to Dr. David N. Taylor, VaxInnate chief medical officer. Egg methods produce vaccines that contain egg proteins, he said, and cell-culture systems have efficiency issues.

"We think that these other approaches are going to be extremely important, because the world is a big place," Dr. Taylor said. "This stuff (H1N1) is going to start spreading around. There's just not enough eggs in the world to handle making this vaccine."

Antigen Express is seeking funding, possibly from foundations or other governments, for development of its own H1N1 vaccine, according to Mr. Powell. Antigen Express, which outsources nearly all operations to other companies, could then generate vaccine material and go into human studies within months, he said. The company might opt for human studies outside the United States, he said.

If Antigen Express could develop an H1N1 vaccine, large-scale production could take place rapidly in existing facilities, Mr. Powell said.

"The capacity exists now that you could literally make billions of doses of this vaccine," he said.

ART: PHOTO

PHOTOG: T&G Staff/RICK CINCLAIR

CUTLINE: Douglas M. Powell, director of immunobiology at Antigen Express Inc., holds a bottle containing human cells used to test vaccines in Worcester.
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Publication:Telegram & Gazette (Worcester, MA)
Date:Jun 23, 2009
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