Novavax and Xcellerex to develop large-scale manufacturing process for VLP flu vaccine

US biotechs Novavax and Xcellerex will collaborate to speed up the development of Novavax's vaccine manufacturing process to commercial scale and begin immediate production of Novavax's 2009 H1N1 influenza vaccine for potential commercial sale. Novavax this week launched a two-stage, 4,000-patient clinical study of its H1N1 flu vaccine in Mexico.

The two companies will use Novavax's virus-like particle (VLP) vaccine technology to produce initial commercial quantities of H1N1 vaccine under Xcellerex's FlexFactory biomanufacturing platform. Xcellerex will provide development expertise and production in exchange for manufacturing supply fees from Novavax.

"Our technology offers Novavax a cost-effective and flexible manufacturing solution by achieving full commercial-scale production of VLP-based vaccines much more rapidly than traditional vaccine production methods," said Joseph Zakrzewski, chief executive of Xcellerex.

"This strategic partnership will allow us to increase the scale of our VLP vaccine manufacturing process and expand capacity to satisfy potential demand for our H1N1 VLP vaccine in Mexico," added Rahul Singhvi, chief executive of Novavax.

Virus-like particles (VLPs) mimic the external structure of viruses but lack the live genetic material that causes viral replication and infection. VLPs can be designed quickly to match individual viral strains and be produced efficiently using portable cell-culture technology. Novavax says its VLP-based vaccine candidates are produced more rapidly than egg-based vaccines by using proprietary, portable, recombinant cell-culture technology.