Novartis has inaugurated the first large-scale flu cell culture vaccine and adjuvant manufacturing facility in the USA.

The plant, at Holly Springs, North Carolina, is the result of a collaboration between the Swiss major and the US Department of Health and Human Services. It is costing around $1 billion and the partners say the pact “highlights an important milestone in efforts to improve influenza vaccine manufacturing technology in the USA and enhance domestic pandemic preparedness”.

Novartis states that cell culture-based production operations are “cleaner, can be scaled up more quickly to respond to a pandemic and do not rely on eggs for rapid response to a pandemic”. However cell culture technology for flu vaccines is not yet approved in the USA, but “HHS contract support for Holly Springs includes funding for the development of a flu cell culture vaccine” and the facility can also start producing Novartis’ MF59 adjuvant, as early as December 2009. The latter is also not approved yet in the USA, but studies are currently underway there.

The Basel-headquartered group said that if licensed in an emergency, the facility will be ready to respond to a pandemic as early as 2011. The plant is expected to be running at full-scale commercial production in 2013.

Novartis already operates a plant in Marburg, Germany, which is licensed to produce a seasonal cell culture-based influenza vaccine, Optaflu. Celtura, the company’s H1N1 pandemic vaccine licensed in Germany and Switzerland, is already being manufactured there.