Novavax Inc. and Xcellerex Inc. announced today they have entered into a strategic collaboration to accelerate the development of Novavax’s vaccine manufacturing process to commercial scale. The companies will begin immediate production of Novavex’s novel 2009 H1N1 influenza vaccine for potential commercial sale. Xcellerex will provide their development expertise and product manufacturing in exchange for manufacturing supply fees from Novavax.
The two companies will utilize Novavax’s unique virus-like particle (VLP) vaccine technology to produce initial commercial quantities of H1N1 vaccine. 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 more rapidly than egg-based vaccines by using proprietary, portable, recombinant cell-culture technology.
The two companies will manufacture the H1N1 influenza vaccine with Xcellerex’s Flex Factory biomanufacturing platform. The Flex Factory effectively eliminates clean room infrastructure, simplifies facility design, reduces manufacturing footprint and capital investment, and offers gains in operating efficiency, flexibility and environmental friendliness.
Earlier this week, Novavax launched a two-stage, 4,000-patient clinical study of its H1N1 flu vaccine in Mexico to support registration in that country. This partnership will allow Novavax to advance the timeline and increase the scale of their VLP vaccine manufacturing process. It also expands the company’s capacity to satisfy potential demand for its H1N1 vaccine in Mexico.