The plant in Holly Springs, North Carolina, received a license from the US Food and Drug Administration (FDA) in June to manufacture Flucelvax and this week celebrated the first shipments of the vaccine Flucelvax from the facility for the 2014-2015 flu season with a ceremony attended by among others, Governor of North Carolina, Pat McCrory.
Flucelvax is the only flu vaccine manufactured using cell-culture technology, rather than influenza strains being grown and harvested in chicken eggs and, according to the Swiss Biopharma, is “the first major innovation in influenza vaccine production in more than 40 years.”
Furthermore, “the manufacturing process does not need advance planning, as frozen cell-culture stocks are readily available, and can be rapidly expanded to initiate production of vaccines in the event of a pandemic.”
The cell-culture-based influenza vaccine production takes place in closed and sterile bioreactors that amplify the virus production in Madin-Darby Canine Kidney (MDCK) cell lines, derived from a female cocker spaniel in 1958.
The process consists of vaccine seed strains being provided to Novartis by the World Health Organization (WHO) from reference centres, while the MDCK cell line is grown in suspension for flu vaccine production, facilitating scalability. The virus is then propagated, purified in an automated and closed system, formulated and filled.
Novartis’ manufacturing facility comprises 44,120m2 of space and employs 550 members of staff. It has the capability to produce 200 million adjuvanted doses of pandemic influenza vaccine within six months of the declaration of an influenza pandemic.