Novartis opens $1bn flu vaccine plant
pharmafile | November 25, 2009 | News story | Manufacturing and Production |Â Â Novartis, US, vaccinesÂ
Novartis has opened a new $1 billion vaccine manufacturing plant that is the first to be set up as a public-private partnership with the US government.
The facility, based on Holly Springs, North Carolina, is also the first large-scale facility to manufacture adjuvanted influenza vaccines using cell culture in the US, although it will not start running at full-scale commercial capacity until 2013.
In an emergency, however, the plant could supply 150 million doses of pandemic vaccine within six months of a pandemic declaration and could respond from 2011, said Novartis. The regular capacity will be around 50 million seasonal flu vaccine doses a year.
In a statement, the Swiss drugmaker said the plant was “an important milestone in efforts to improve influenza vaccine manufacturing technology in the US and enhance domestic pandemic preparedness”.
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 response to emerging flu strains.
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 vaccine for a minimum of three years.
The new plant will also be able to make flu vaccines with Novartis’ immune response-boosting adjuvant MF59.
Novartis recently won approval in Europe to sell in Germany and Switzerland its MF59-adjuvanted cell-based H1N1 vaccine Celltura, which is made at its cell culture plant in Marburg, Germany, but as yet the US has not approved any adjuvants for use alongside flu vaccines.
The use of the adjuvant cuts the amount of antigen needed to generate a protective response. Celltura contains 3.75mcg of antigen, compared to 15mcg with Novartis’ non-adjuvanted H1N1 vaccine.
“We are proud to be one of the first companies to bring influenza cell culture as well as adjuvant technology to the US,” said Novartis chief executive Daniel Vasella.
The US government has come under criticism lately for not implementing emergency measures to allow adjuvants to be used for pandemic flu vaccines, exacerbating shortages of H1N1 vaccine stocks.
The US Centers for Disease Control and Prevention (CDC) estimates that around 50 million people have been vaccinated against the H1N1 strain of flu to date, well short of its target of 160 million people.
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