Novartis opens first flu vaccine cell culture plant in US
Swiss pharmaceutical group Novartis has officially inaugurated the first large-scale flu cell culture vaccine and adjuvant manufacturing facility in the US.
Swiss pharmaceutical group Novartis has officially inaugurated the first large-scale flu cell culture vaccine and adjuvant manufacturing facility in the US.
The facility, which has cost almost US$1bn, is a partnership between Novartis and the US Department of Health and Human Services (HHS).
Basel-based Novartis says the plant in Holly Springs, North Carolina, is the first of its kind in the US and a "milestone" in efforts to improve influenza vaccine manufacturing technology in the US and will ensure that the US is prepared for a domestic pandemic.
The facility will use modern, cell culture-based manufacturing technology instead of the chicken egg process. The company says cell culture-based production operations are cleaner and can be scaled up more quickly to respond to a pandemic.
Although cell culture technology for influenza vaccines is not yet approved in the US, part of the HHS contract support for Holly Springs includes funding for the development of a flu cell culture vaccine.
If licensed in an emergency, the facility could respond to a pandemic from 2011. It is designed to supply 150 million doses of pandemic vaccine within six months of a pandemic being declared.
Full-scale commercial production will start in 2013.
Novartis already operates a cell culture-based manufacturing plant in Marburg, Germany. It is licensed to produce a seasonal cell culture-based influenza vaccine, Optaflu, which is approved in the EU, as well as in Iceland and Norway. It currently produces Celtura, a H1N1 pandemic vaccine licensed in Germany and Switzerland.
The Novartis Holly Springs facility can also start producing MF59, the Novartis proprietary adjuvant, as early as December 2009. Although not yet approved in the US, trials with adjuvants are currently underway in the US.
A single 3.75μg dose of Novartis" cell-based MF59-adjuvanted A(H1N1) 2009 vaccine will protect against influenza A(H1N1) in children aged 3 to 8, adults aged 18 to 64, and the elderly. This compares with 15μg for a vaccine made without an adjuvant, meaning that using MF59 could effectively quadruple vaccine supply.