Sanofi hikes flu vaccine capacity with new US plant
pharmafile | May 11, 2009 | News story | Manufacturing and Production |Â Â Sanofi-Aventis, h1n1Â
Sanofi-Aventis has been given a green light for a new $150 million flu vaccine manufacturing plant in the US that can be used to manufacture shots against H1N1 swine flu.
The unit, operated by Sanofi-Aventis' vaccines subsidiary Sanofi Pasteur, has been approved by the US Food and Drug Administration (FDA) to make the company's seasonal flu vaccine Fluzone and triples the company's manufacturing capacity for the product.
It also stands ready to start production of a vaccine against the circulating influenza A/H1N1 pandemic strain, according to the company, which said it is waiting for the nod from the World Health Organization (WHO) and national health authorities.
Work is still ongoing on a seed train of the virus that could be used to generate vaccine antigen.
Last week the WHO said it is considering issuing a recommendation for drug manufacturers to stop production of seasonal flu vaccine and concentrate instead on swine flu vaccines.
A decision will be taken early this week, said the WHO, although it stressed the switch would only be made if an investigation finds there are sufficient doses of seasonal vaccine in reserve.
Sanofi Pasteur's new facility in Swiftwater, Pennsylvania, is geared up to make vaccine using a conventional egg-based production technology, so would require four to six months to generate vaccine once the go-ahead has been given.
Cell culture-based production methods are faster but the company's efforts in this area have so far reached phase II clinical development and are still some way away from being a workable option.
Nevertheless, the new plant adds welcome production capacity as the scale of the swine flu outbreak remains under scrutiny, according to the FDA.
"Increased manufacturing capacity for influenza vaccine is critical to our preparedness for an influenza pandemic," said Dr Jesse Goodman, the FDA's acting chief scientist. Goodman is a recognised expert in influenza vaccines and is leading the agency's effort on the swine flu outbreak.
Sanofi Pasteur said it will have a capacity to make around 150 million doses of trivalent seasonal influenza vaccine a year for the US market, with 50 million doses coming from an older facility and 100 million doses from the new plant.
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