J&J Signs two new Covid-Vaccine Pacts
As part of a plan to establish a network of manufacturing partners to help boost capacity ahead of a potential FDA approval of a Covid-19 vaccine, US healthcare giant Johnson & Johnson (J&J) recently signed agreements with two US companies.
J&J’s ambition is to prove infectious diseases experts wrong that a new vaccine cannot be developed in less than a year to a year and half. The company’s own target is to rapidly produce 1 billion doses on a not-for-profit basis. First trials are slated to begin in September; however, it wants to have emergency doses ready to use prior to regulatory approval.
In its latest pact, financial terms of which were not disclosed, J&J has agreed a collaboration with Catalent to ramp up capacity at that company’s Bloomington, Indiana plant, leveraging the facility’s "deep expertise" in sterile formulation. Both US players are headquartered in New Jersey.
The joint goal is to reach 24/7 manufacturing schedules by January 2021, the companies said. To this end, Catalent plans to hire an additional 300 workers at the Indiana plant starting in July 2020. The scale-up would involve the use of high-speed machines for vial filling and carton loading.
Along with contributing its experience in drug substance development and manufacturing, as well as drug product fill/finish to the collaboration, Catalent will also leverage its network of sterile drug facilities in Brussels, Belgium and Anagni, Italy.
Just prior to the Catalent linkup, J&J inked a $135 million deal with Gaithersburg, Maryland-based Emergent BioSolutions to ramp up production of the vaccine ahead of human trials in September.
Emergent will provide drug substance manufacturing services with its molecule-to-market CDMO offering, supported by investments from Johnson & Johnson beginning in 2020, and will reserve certain large-scale manufacturing capacity to pave the way for commercial manufacturing of J&J subsidiary Janssen’s adenovirus-based Covid-19 vaccine beginning in 2021.
Emergent’s Baltimore Bayview facility, a Center for Innovation in Advanced Development and Manufacturing (CIADM) designed for rapid manufacturing of vaccines and treatments in large quantities during public health emergencies, is part of a public-private partnership with the US Department of Health and Human Services (HHS).
J&J will expand its own capacity for producing the vaccine candidate at Leiden, the Netherlands, for clinical vaccine production and, there, too, plans to produce the vaccine "at-risk" to support human trials.
