At the 2013 annual meeting of the International Society for Pharmaceutical Engineering (ISPE), the society announced that Novartis’ US Flu Cell Culture (USFCC) facility in Holly Springs, North Carolina, is the overall winner of the 2013 Facility of the Year Awards (FOYA). The FOYA program, sponsored by ISPE, recognizes state-of-the-art pharmaceutical manufacturing projects that use new and innovative technologies. Category winners, announced in April 2013 at INTERPHEX, were Biogen Idec for Facility Integration, F. Hoffmann-La Roche for Project Execution, MedImmune for Equipment Innovation, Merck & Co. for Operational Excellence, Morphotek for Sustainability, and Novartis Vaccines and Diagnostics for Process Innovation.
The Novartis Vaccines and Diagnostics USFCC facility is based on an innovative mammalian cell-culture technology for manufacturing flu vaccines that is an alternative to traditional egg-based production. Flucelvax, the seasonal influenza vaccine produced with the new technology, was approved by FDA in November 2012. The Holly Springs facility will have a seasonal capacity of 50 million trivalent doses. In addition to seasonal vaccine production, cell-culture technology enables more rapid response to potential pandemic influenza vaccine demand. The facility will be capable of producing and filling at least 150 million doses of pandemic monovalent vaccine within six months of the declaration of a pandemic.
The facility uses closed-system bioreactors, which reduces the required biosafety level for the manufacturing space. In case of a pandemic, the facility can be enhanced to operate at higher biosafety levels. This approach to containment convertibility allows reduced operating costs, ISPE noted in its description of FOYA winners.