Novartis takes top honours in ISPE facility competition
pharmafile | November 12, 2013 | News story | Manufacturing and Production |Â Â Novartis, WHO, foya, holly springsÂ
Novartis’ cell culture facility in the US for the production of influenza vaccines has claimed the top prize in the 2013 Facility of the Year Awards (FOYA).
The plant in Holly Springs, North Carolina, had already been named a winner in the Process Innovation category earlier this year and uses a deep tank mammalian cell culture technology to make flu vaccines rather than conventional egg-based systems.
Novartis has been investing in cell culture production for its flu vaccines business and the 300,000 sq. ft. unit in Holly Springs – backed with almost $500 million in US government funding – is the centrepiece of that effort.
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 and flexible response to seasonal and pandemic flu strains.
The time required to make vaccines in eggs means that the World Health Organization (WHO) has to make an educated guess about the strains of flu that will be circulating in a given season several months ahead of time. Drugmakers then produce flu vaccines based on that advice, and the production delay sometimes means that the shots produced are an imperfect match.
Other advantages are that process raw materials are readily available and not threatened by pandemic events, while the Holly Springs plant also uses closed-system bioreactors that reduce the required biosafety level for the manufacturing space.
In addition to the breakthrough technology associated with their mammalian cell culture process, ISPE notes the Novartis team used creative ways to improve other facility operations, including the application of ‘containment convertibility’, an approach which allows the facility to operate at varying containment levels. As a result the unit can reduce its operating costs by only working to higher containment modes when needed.
“The proprietary technology at Novartis’ US Flu Cell Culture Facility enables flexible and fast start-up of vaccine manufacturing, offering rapid response to potential pandemic influenza threats while fulfilling the need for seasonal influenza vaccine,” said FOYA organiser the International Society of Pharmaceutical Engineering (ISPE) in a statement.
Holly Springs “exemplifies the type of advancements in pharmaceutical and biotechnology manufacturing technology that the FOYA programme seeks to recognise”, added the ISPE.
Phil Taylor
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