Novavax is stepping up the pace of its H1N1 vaccine manufacturing process as it works through a two-stage, 4,000-subject trial in Mexico. The novel vaccine maker is working with Xcellerex, using the latter's single-use FlexFactory biomanufacturing platform, development expertise, and manufacturing services to ramp up to commercial scale and begin production.
Novavax has just launched a trial of the vaccine in Mexico to support registration there. In the deal, Xcellerex will provide the development expertise and vaccine manufacturing in exchange for manufacturing supply fees.
The vaccine is based on Novavax's virus-like particle (VLP) technology. VLPs mimic viruses in structure but lack their infectious genetic material. Over the next quarter, Xcellerex will step up manufacturing volumes until reaching full commercial scale, says CEO Joseph Zakrzewski. "This deal further validates what we've been saying about how quickly this technology can be used. It continues to prove out the technology."
Zakrzewski also says that Xcellerex is "getting ready" to submit an undisclosed vaccine of its own.
Earlier this month, specialty biopharma Itero also capitalized on Xcellerex's combination of disposable technology, contract manufacturing and drug development capabilities to help shorten development time for an undisclosed therapeutic protein drug candidate. Xcellerex is using its PDMax process development platform and the FlexFactory disposable technology in providing the services.
Links:
[1] http://www.novavax.com/download/releases/Xcellerex%20Oct%2009%20FO.pdf
[2] http://www.fiercepharmamanufacturing.com/story/itero-finds-synergy-xcellerex/2009-10-05