The Centers for Disease Control and Prevention (CDC) has warned that vaccine production is below expectations in the US and Mexico, in part because of lower than expected yields from egg-based systems.
Novavax has risen in prominence during the H1N1 outbreak, as it did during the H5N1 scare, because it claims its virus-like particles (VLP) can be produced more rapidly than egg-based vaccines.
To further this focus on speed Novavax has teamed with Xcellerex, a contract manufacturing organisation (CMO) and developer of disposable technologies, to cut the time taken to reach commercial scale production.
In exchange for supply fees Xcellerex will provide development expertise and produce Novavax’s VLP using its FlexFactory disposable biomanufacturing platform. FlexFactory can cut overall time to production by 70 per cent, according to Xcellerex, and this could be crucial in a pandemic.
Novavax is initially using FlexFactory on a contract basis but the operations can by physically transplanted from Xcellerex’s manufacturing facility to another and restarted “almost immediately”.
These features are possible because the system is “built almost exclusively around disposables technology” and each unit is self-contained in its own controlled environment module (CEM), which eliminates the need for cleanrooms.
Eliminating cleanrooms helps cut capital investment by 50 per cent or more, according to Xcellerex, and running costs are also lower because the system reduces water use by 70 per cent.
Trials in Mexico
News of the deal with Xcellerex was released shortly after Novavax published information about the initiation of clinical trials in Mexico. The trial will take place in two parts, firstly to evaluate the vaccine’s safety, immunogenicity and efficacy in 1,000 patients.
Novavax will follow this with a safety trial in 3,000 patients. Data from the trials will be used to seek approval for the 2009 H1N1 pandemic flu vaccine in Mexico and will support development of Novavax’s VLP portfolio in other countries.