The French pharmaceutical company injected $150m (€108.6m) into the 140,000sq ft. facility in Swiftwater which will see it manufacturing more than 100 million doses of influenza vaccine per year.
"As the world's largest supplier of influenza vaccines, Sanofi Pasteur is committed to addressing current and future public health needs by investing in a robust research and development programme and an ambitious production plan for pandemic preparedness," Sanofi Pasteur chief executive and chairman David Williams said in a statement.
"The completion of this new facility incorporating the latest technology in vaccine production, illustrates the company's priority to produce the largest number of doses of vaccine in the shortest time frame to face the threat of seasonal and pandemic influenza."
The new facility has been designed with the latest state-of-the-art technologies, with improved work flow, and increased sterility mechanisms, such as air lock barriers and filtration units, to keep the integrity of the product and reduce the chances of contamination, Sanofi Pasteur spokesman Len Lavenda told in-PharmaTechnologist.com.
In terms of the manufacturing process, he said "it is fundamentally the same process" but "there is a significant improvement of certain technologies."
The new facility, construction of which began in July 2005, is the second facility Sanofi Pasteur has in the US - the other plant is located a few hundred yards away and is to undergo a retrofit as part of a $77.4m grant from the US Health and Human Services, announced last month, which would give Sanofi the ability to contribute 150 million influenza doses to the US Government in the case of a pandemic.
The new plant is expected to come on line late 2008 or early 2009, following the facility's licensing by the US Food and Drug Administration (FDA), at which time operations will cease at the other plant, which currently has a capacity of 50 million doses per year, and the retrofit activities will begin. This would include a complete overhaul of the building, inside and out, including replacing all equipment, Lavenda said.
The company would be contributing approximately $25m toward the retrofit project.
The two plants will only produce influenza; seasonal and if needed, pandemic, including stockpiling.
The US plants are the only ones supplying influenza vaccine to the US, although the French and Canadian sites the company has, supply other vaccines to the US.
Currently, the company's global capacity for influenza vaccine is 175 million doses - 50 million in the US and 125 million in France - representing about 40 per cent of the global capacity for influenza vaccine. In three years, Lavenda said the projected global capacity will be between 250 and 300 million doses.
The Swiftwater site is situated on approximately 500 acres with room for future growth, Lavenda said.
Sanofi Pasteur is the only company manufacturing egg-based inactivated influenza vaccine in the US.
The company is also expanding its influenza vaccine capacity in France where it is investing €200m into a formulation and filling facility in Val de Reuil, expected to be completed about 2010.
In April, Sanofi won US approval for an H5N1 avian virus strain vaccine, the only company to have such approval, though GlaxoSmithKline and Novartis are both working on their own vaccines.
The World Health Organization (WHO) estimates global flu vaccine capacity is at fewer than 400 million doses a year, and current demand hitting 300 million doses a year. WHO claims the industry is woefully under-prepared for a pandemic that could shoot demand up by 20 times.
About 200,000 people are hospitalized in the US every year with influenza. An additional 36,000 people die annually from the disease.
If a pandemic occurred without a vaccine, the WHO estimates that at least 50 million people could die. In the 1918-1919 Spanish flu outbreak, 50 million people died.
Currently, GlaxoSmithKline (GSK), Sanofi-Aventis, Novartis and MedImmune manufacture seasonal influenza vaccines for the US.
