Emergent BioSolutions will collaborate with Novavax, utilizing its molecule-to-market contract development and manufacturing (CDMO) services to support bringing into the clinic Novavax’s novel experimental vaccine candidate to protect against coronavirus disease (COVID-19).
Under the terms of the agreement, Emergent will produce the COVID-19 experimental vaccine candidate, which is based on the proprietary recombinant protein nanoparticle technology platform of Novavax and utilizing their proprietary Matrix-M™ adjuvant to enhance immune responses. Emergent has initiated work for this program anticipating that the COVID-19 experimental vaccine candidate will be used in a Phase 1 clinical study within the next four months.
“We are pleased with our Novavax collaboration, which reflects Emergent’s commitment to advancing potential solutions to combat coronavirus disease. As we provide our CDMO services, backed by our established track record as a trusted partner to governments, industry, and non-government organizations, we leverage our long history in vaccines and therapeutics development and manufacturing, as well as our broad capabilities focused on medical countermeasures for emerging infectious diseases. The increasing threat of COVID-19 requires a comprehensive response and we continue to evaluate various vaccine, therapeutic, and CDMO approaches to enable us to marshal resources to make a meaningful impact on this global public health emergency,” Robert G. Kramer Sr., president and chief executive officer at Emergent BioSolutions, said.
In support of the COVID-19 experimental vaccine candidate’s progression into the clinic, Emergent has mobilized its integrated clinical and commercial development and manufacturing network to provide development services out of its Gaithersburg, Md location as well as manufacturing services out of its two Baltimore, Md facilities. Drug substance will be produced at the 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), while drug product will be produced at the Baltimore/Camden location.
“Emergent is proud to demonstrate its ability to rapidly deploy capabilities, capacities, and expertise as part of our molecule-to-market CDMO offering to support the development and commercialization of essential medicines,” said Syed T. Husain, senior vice president and CDMO business unit head at Emergent BioSolutions. “Always at the core of our response is our desire to fulfill our mission – to protect and enhance life.”