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:
- Facility Integration: Biogen Idec, for its Flexible Volume Manufacturing (FVM) facility located at Research Triangle Park, North Carolina, US. The facility produces treatments for neurodegenerative diseases, haemophilia, and autoimmune disorders.
- Project Execution: F Hoffman La Roche, for it Technical Research and Development (TR&D) Building 97, in Basel, Switzerland. The project was initiated to consolidate the Roche research and development groups for oral solid dosage and liquid parenteral dosage forms for clinical studies into one facility.
- Equipment Innovation: MedImmune, UK for its Automation Upgrade Project. Recognising that its egg-based bulk vaccine manufacturing process would not support a rapid increase in production of its influenza vaccine Intranasal, MedImmune implemented this project, which included a series of innovations to its equipment line in Speke, Liverpool, UK.
- Operational Excellence: Merck & Co, for its Vaccine and Biologics Sterile Facility (VBSF) in Carlow, Ireland. This was Merck’s first green-field sterile processing facility built outside the US and from the beginning, the project team was committed to employing a Lean Six Sigma philosophy as the foundation for every part of the project.
- Sustainability: Morphotek, for its Pilot Manufacturing Plant in Exton, Pennsylvania, US. The plant supports the manufacturing of advanced therapeutic candidates with either cell culture or microbial systems.
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.
