Which came first - the spaniel or the egg?
If we are talking about influenza vaccine production then the answer is definitely egg. Hens’ eggs have been used for this purpose since shortly after Woodruff and Goodpasture discovered they could be used for viral culturing in 1931.
But, if the question is “which plays the most important role in flu vaccine production: the spaniel; or the egg?”, the answer could soon be ‘spaniel’ after Novartis was licensed to start making seasonal influenza vaccine at its cell culture plant in Holly Springs, North Carolina this week.
The Swiss drugmaker manufacturers its vaccines using Madin-Darby Canine Kidney (MDCK) cells derived from a female cocker spaniel in 1958, which provide for a much simpler and more reliable production process according to spokeswoman Elizabeth Power.
“Traditional influenza vaccine production depends on a large number of fertilized chicken eggs to grow virus strains and requires many months for organization of egg supplies, virus incubation and actual production before the vaccine is delivered to physicians or pharmacies.”
“Cell-culture manufacturing technology is an alternative production method to traditional egg-based production. Cell-culture technology utilizes a well-characterized mammalian cell line rather than chicken eggs to grow virus strains” Power continued.
She went on to tell BioPharma-Reporter.com that while the facility was already producing trial supplies of Novartis’ Flucelvax and adjuvants used in other products “the FDA licensure means that Holly Springs will produce seasonal flu vaccine for the 2014-2015 flu season.”
Novartis was contracted to develop the Holly Springs site for cell-culture vaccine production in 2007 by the US Department of Health and Human Services (HHS) as part of both the US’ seasonal vaccine production efforts and its pandemic preparedness programme.
Power explained that: “As part of its contract with the US government, the site has also developed and tested vaccines and manufactured bulk stockpiles of antigens and adjuvants for pandemic threats, including H7N9 influenza, which emerged in 2013.”