Novavax, Inc. (Nasdaq:NVAX) announced today that all equipment in its new Good Manufacturing Practice (“GMP”) Pilot Plant to manufacture pandemic and seasonal influenzavaccine clinical supplies and commercial batches at a 1,000 liter scale areinstalled and ready for operations supporting scale-up and validation. The project was initiated in December 2007. The facility demolition, construction and initial qualification were completed in 120 days and wereannounced with a ribbon cutting in May 2008. The original design by Jacobs Engineering (Conshohocken, PA), which included multiple Wave bioreactors for production of VLPs, has been modified to include stirred reactors based on the potential for enhanced production yield. The stirred reactors, which utilize disposable liners in keeping with the desire to maintain a disposable manufacturing process, were received September 2008 and are now installed in the facility. The facility is expected to be capable of producing 2-3 million doses of monovalent pandemic influenza vaccine per week at 15 mcg HA/dose (50 – 75 M doses in 6 months) once scale-up and validation are complete. Likewise, the facility can support up to 20 – 25 million doses of trivalent influenza vaccine in six months. The facility is GMP compliant and includes a total of 10,000 square feet of production and support space. The facility also includes media and reagent preparation space and equipment for production of vaccine for clinical trials. Large-scale commercial production, media, reagent and filling of bulk vaccines are planned to be outsourced. The total cost of the project, including demolition, construction, and installation of laboratory and production equipment, was approximately $5 million. The facility had existing mechanical systems in place (pharmaceutical air and water system) that were not included in the project cost. This facility serves as a prototype for regional ‘in-border’ pandemic influenza production facilities which are offered to governments who want to ensure a rapid supply of pandemic influenza vaccine for their country. To keep the facility in a state of operational readiness for pandemic influenza production, seasonal influenza vaccine and other future VLP-based vaccines from Novavax may also be prepared. Additional information including an article published in BioPharm International (January 2009) and photographs of the facility are available on Novavax’s website: http://www.novavax.com/ under the manufacturing section. The next steps for the facility include scale-up and validation of the process at full 1000L commercial scale, production of consistency lots for influenza vaccines, and regulatory review of the manufacturing and validation data once phase 3 clinical results are complete. “The facility demonstrates the low capital cost of manufacturing with single use systems,” said Jim Robinson, Vice President of Technical and Quality Operations. “Other manufacturers are spending hundreds of millions of dollars to build similar capacity. The high cost of typical vaccine manufacturing makes it difficult for a country to afford self-reliance for pandemic flu vaccine supply. Novavax can make a difference in protecting populations through our innovative manufacturing approach and our collaboration with GE Healthcare.” “This $5 million investment is the last significant capital expenditure required for manufacturing until after product launch,” said Rahul Singhvi, CEO. “It supports our development pipeline and initial commercial needs. The facility can be expanded with additional bioreactors for additional capacity if needed.”
