For its flu cell culture facility in Holly Springs, North Carolina, US
Novartis’s flu cell culture facility has been named the Overall Winner of the ISPE 2013 Facility of the Year Awards (FOYA) programme.
The facility in Holly Springs, North Carolina, US represents a breakthrough use of innovative technology and development of a large-scale manufacturing process to produce seasonal and pandemic influenza vaccines. This process breaks with the 50-year tradition of using eggs for the method of growing the virus in favour of a ground-breaking cell culture technology that offers many potential advantages over the traditional manufacturing process for flu vaccines.
These advantages include process raw materials that are readily available and not threatened by pandemic events and closed-system bioreactors that reduce the required biosafety level for the manufacturing space.
The proprietary technology at Novartis’s 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 vaccines.
In addition to the breakthrough technology associated with their mammalian cell culture process, the Novartis team used creative solutions in other facility operations, notably their approach to Containment Convertibility, which allows the facility to operate at BSL -1, -2, and -3 levels to reduce operating costs associated with the need to operate in higher containment modes on demand.
For forging a path in a new frontier for vaccine production, the Facility of the Year Award judging panel also named Novartis as winner of the Process Innovation category.
The other category winners were:
The Facility of the Year Awards (FOYA), now in their 10th year, recognise state-of-the-art pharmaceutical manufacturing projects that use new and innovative technologies to enhance the delivery of a quality project, as well as reduce the cost of producing high-quality medicines.