Jun 23, 2009 (CIDRAP News) – The US government has granted Protein Sciences Corp. (PSC) of Meriden, Conn., a $35 million contract to develop its technique for making influenza vaccines by growing flu virus proteins in insect cells, an approach said to be faster than traditional methods.
"The technology has advanced in recent years to the point that we believe it could help meet a surge in demand for US-based vaccine for seasonal and pandemic flu," Health and Human Services (HHS) Secretary Kathleen Sebelius said in a press release today.
PSC's approach involves extracting a gene from a flu virus and inserting it into a baculovirus, which infects insects but not people. The recombinant baculoviruses multiply quickly in insect cells, producing many copies of the flu gene, and the cells are purified and used to make a vaccine, HHS said.
The method may make it possible to produce vaccine candidates, vaccine for clinical trials, and commercial-scale amounts of vaccine faster than with the traditional method of growing flu viruses in chicken eggs, the agency said. It said the insect cells can be frozen and stored indefinitely, contributing to faster large-scale production.
If the technology is licensed by the Food and Drug Administration, the company will be required to establish a domestic manufacturing capability. The contract calls for the company to be prepared to make a finished vaccine within 12 weeks after a pandemic onset and to make 50 million doses within 6 months after pandemic onset, according to HHS.
The contract could be extended up to 5 years at a total cost of about $147 million, HHS officials said.
PSC has said it is using its baculovirus and insect-cell technology to make a vaccine for the novel H1N1 flu virus. On Jun 15 the firm announced it had begun manufacturing the vaccine, called PanBlok, and estimated it would be able to make 100,000 doses per week.
But the vaccine, like any other, will require extensive animal and human testing and regulatory approval before it can be marketed.
The HHS contract award came a day after a report that creditors of PSC had filed a petition to force the company into bankruptcy in an effort to collect on their claims.
Bloomberg News reported that creditors filed an involuntary Chapter 7 bankruptcy petition against the company yesterday in US Bankruptcy Court in Wilmington, Del. The petition listed claims totaling $11.7 million, the story said.
Most of the debt—$11.5 million—is owed to Emergent BioSolutions Inc., Bloomberg reported. Emergent, which makes the only anthrax vaccine licensed in the United States, had agreed to buy most of PSC's assets last year. On May 1 of this year, PSC announced it had reached a deal with Emergent that set terms for repaying a loan, terminated the 2008 asset purchase agreement, and resolved outstanding litigation.
See also:
HHS Jun 23 announcement of contract with PSC
http://www.hhs.gov/news/press/2009pres/06/20090623c.html
May 1 CIDRAP News story "Path to swine flu vaccine has major hurdles"
