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Sanofi receives H1N1 strain and gears up for production
 
 
  By Gareth Macdonald, 28-May-2009
 
http://www.in-pharmatechnologist.com
 
Sanofi Pasteur, the vaccines unit of French drug major Sanofi Aventis, has received a reference strain of the H1N1 swine flu virus from the US CDC and expects to complete work on an industrial "seed stock" in the next two weeks.
 
Earlier this week Sanofi announced a $190m (136.5m) Department of Health and Human Services (HHS) contract to produce H1N1 vaccine and suggested that other orders would follow.
 
The Centers for Disease Control and Prevention (CDC) confirmed that it has sent the virus to Sanofi and several other drug makers, meaning that the race to produce pilot lots of vaccine for safety and efficacy testing is underway.
 
The CDC has approved two H1N1 seed strains, one produced via the classical egg based culturing method and another made using a patented reverse genetics method developed by Maryland-based MedImmune for its inhaled influenza vaccine FluMist.
 
Wayne Pisano, CEO of Sanofi Pasteur, said that the firm: "looks forward to quickly understanding how this virus performs in a vaccine manufacturing environment."
 
Development will be carried out at Sanofi's newly certified facility in Swiftwater, Pennsylvania with work on seasonal influenza vaccine development usually carried out at the site being relocated to a nearby plant also owned by the firm.
 
In contrast, GlaxoSmithKline (GSK) has not yet been sent a reference strain by the CDC but "should receive it soon" according to comments made by spokesperson Marie-Christine Beauchemin in The Canadian Press.
 
According to a recent report by the World Health Organization (WHO) there have been 12,515 cases in 47 countries, with over 90 people believed to have died after contracting H1N1.
 
In addition, the WHO said that human to human transmission has been observed in at least two countries, making rapid industrial scale-production of an effective vaccine even more of a priority.
 
 
 
 
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