Novavax praises disposable systems at site launch
The facility houses multiple Wave bioreactors for production of virus like particles (VLPs) and stirred reactors, which Novavax believes produce greater yields than the alternatives.
Increasing yield has helped Novavax reduce costs but the biggest savings have been generated by the use of disposable systems, according to the company. The project cost of $5m does not include charges for mechanical systems, such as pharmaceutical air and water system, as they were already in place.
Jim Robinson, vice president of technical and quality operations, said: "The facility demonstrates the low capital cost of manufacturing with single use systems. 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."
Novavax claims that disposable systems reduce costs as stainless steel equipment is not required. This equipment also requires clean-in-place and sterilise-in place equipment, parts washers and clean steam generators to be installed, which further drives up costs.
When scale-up and validation are complete the Novavax claims the 10,000 sq ft facility will be capable of producing 2-3m doses of monovalent pandemic influenza vaccine per week.
Work on the facility began in December 2007 with the demolition of the existing building on the site. Within 120 days the new facility had been built and undergone initial validation.
It has been constructed to manufacture clinical trial lots for Novavax’s Phase III trials and for subsequent commercial production. Additional bioreactors can be installed if commercial demand exceeds current capacity.
