Novartis opens cell-based flu vaccine plant in US
pharmafile | December 15, 2011 | News story | Manufacturing and Production | Novartis, celll-based, vaccines
Novartis has officially started production at a first-of-its kind cell-based manufacturing facility for influenza vaccines in North Carolina, US.
The Swiss drugmaker has been investing in mammalian cell culture production capacity for its flu vaccines business as an alternative to conventional egg-based culture, and the billion-dollar facility in Holly Springs is the centrepiece of that effort.
Cell-based production cuts the time it takes to produce the antigens used in vaccines from months to weeks compared to conventional chicken egg-based production, allowing a more rapid and flexible response to seasonal and pandemic flu strains.
The time required to make egg-based vaccines means that the World Health Organization (WHO) has to make an educated guess about the strains of flu that will be circulating in a given season several months ahead of time. Manufacturers produce flu vaccines based on that advice, and the production delay sometimes means that the shots produced are an imperfect match.
The US government contributed $487 million to the plant’s start-up costs, and in return will be supplied with two commercial-scale annual lots of pre-pandemic H5N1 vaccine for a minimum of three years.
The first three lots of the vaccine – amounting to around 6.5 million doses – will be completed within the next few days, and when fully operational the plant will be able to serve around 25% of the US demand for vaccine during a flu pandemic.
Bringing the plant online marks “the first change in influenza vaccine manufacturing in the US in 50 years”, according to Robin Robinson, director of the Biomedical Advanced Research and Development Authority (BARDA) at the US Department of Health and Human Services.
“The pandemic readiness of this facility is a major milestone in national preparedness for pandemic influenza and other diseases.”
Novartis is also building a $36 million development lab and pilot plant at the site, with completion expected in early 2012, according to a company statement.
Phil Taylor
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