ROCKVILLE, Md., Jan. 26 /PRNewswire-FirstCall/ -- Novavax, Inc. (Nasdaq: NVAX) announced today that all equipment in its new Good Manufacturing Practice ("GMP") Pilot Plant to manufacture pandemic and seasonal influenza vaccine clinical supplies and commercial batches at a 1,000 liter scale are installed 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 were announced 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 me
|SOURCE Novavax, Inc.|
Copyright©2009 PR Newswire.
All rights reserved