Emergent BioSolutions announced Tuesday a partnership agreement with Novavax, under which it will provide molecule-to-market contract development and manufacturing (CDMO) services to produce Novavax’s NanoFlu.
NanoFlu is Novavax’s seasonal influenza vaccine candidate with the proprietary Matrix-M adjuvant. NanoFlu met all primary objectives in its Phase 3 clinical trial evaluating immunogenicity and safety in adults aged 65 and older.
“Emergent is pleased to expand our collaboration with Novavax to include large-scale production of NanoFlu, their novel influenza vaccine,” said Syed Husain, senior vice president and CDMO business unit head at Emergent BioSolutions. “Our flexible and integrated CDMO offerings allow us to work with expedited timelines, execute on simultaneous engagements, and serve varying needs and approaches of customers like Novavax. As a trusted partner, we are committed to supporting Novavax’s goals to advance their influenza program while maintaining the option to allocate capacity for a potential scaled-up COVID-19 program.”
Emergent will provide drug substance manufacturing services, including technology transfer and process validation and performance qualification for commercial manufacturing.
The work will be done at Emergent’s Baltimore Bayview location, which is designated by the U.S. Department of Health and Human Services (HHS) as a Center for Innovation in Advanced Development and Manufacturing (CIADM). This is also where the COVID-19 experimental vaccine candidate of Novavax is also being produced.
“Our confidence in partnering with Emergent comes from their reputation for high-quality production and ability to scale-up manufacturing,” Novavax President and CEO Stanley Erck said. “We believe Emergent’s manufacturing capabilities will allow us to capitalize on NanoFlu as an innovative, improved alternative to traditional egg-based flu vaccines.”
Emergent’s Bayview facility has the capability to get candidates rapidly into the clinic while scaling up to enable large-scale manufacturing to up to 4000L to prepare for production of commercial volumes. Also, as a CIADM, it can produce tens to hundreds of millions of doses of vaccine annually.