Johnson & Johnson has signed a deal with contract development and manufacturing organisation (CDMO) Emergent BioSolutions to support efforts to manufacture its lead investigational COVID-19 vaccine candidate, the US pharmaceutical company has announced.
Under the terms of the agreement, valued at around USD 135 million, J&J will expand drug substance capacity related to the vaccine candidate.
Emergent will provide drug substance manufacturing services with its molecule-to-market CDMO offering later this year and will also reserve capacity to support commercial manufacturing of the vaccine candidate net year should it gain regulatory approval.
Large-scale manufacturing of drug substance for the vaccine will be done at Emergent’s Baltimore Bayview facility, which was designed for rapid mass-production of vaccines and treatments during public health emergencies.
J&J has already begun preparations for clinical vaccine production at its facility in Leiden, the Netherlands, and plans to start Phase 1 human trials of its vaccine candidate in September.
The firm said it will begin vaccine production ‘at risk’ to support the trials and has committed to bringing an affordable vaccine to market on a not-for-profit basis for emergency pandemic use.
“We have set a high bar,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, J&J. “Johnson & Johnson has committed to rapidly produce and supply more than one billion doses of a safe and effective vaccine globally. Our collaboration with Emergent is proof that we are moving quickly to deliver on that promise.”
J&J said it is also aiming to rapidly scale up vaccine manufacturing globally, including increasing capacity outside the US, to support potential rapid production of a vaccine.