- Moderna, the Cambridge, Massachusetts-based biotech at the forefront of coronavirus vaccine development, has enlisted Catalent to help with the final manufacturing steps of filling vials and packaging doses.
- Under an agreement announced Thursday, Catalent will ramp up staffing to support filling and finishing 100 million doses of Moderna's vaccine candidate, supply that's intended for distribution in the U.S. beginning in the third quarter.
- The companies are also in talks about working together on hundreds of millions of additional doses. Vial filling and packaging are the last few steps in the vaccine manufacturing supply chain, but could become a bottleneck as companies like Moderna try to make enough vaccine to provision the world.
Vaccine makers are speeding up already unprecedented development timelines as they seek a counter to the new coronavirus, which has infected 9.5 million people around the world.
Moderna is now working with the National Institutes of Health to begin a late-stage trial of its candidate in July; just two months ago, the company had hoped to begin the study this fall.
But even as they move with lightning speed, drugmakers are facing the daunting challenge of producing enough vaccine for the world. They are coping with the need to find more manufacturing capacity, as well as potential shortages of the vials needed to hold any successfully developed vaccine.
Catalent will provide vial filling work for Moderna at an 875,000-square-foot biologics facility in Bloomington, Indiana. The site recently expanded its capacity and its packaging lines are fully automated. Catalent said it intends to run operations 24 hours a day, seven days a week.
The New Jersey-based contract manufacturer is now involved in several efforts to produce a coronavirus vaccine. In April, Catalent agreed to manufacture Johnson & Johnson’s lead vaccine candidate in Bloomington. And this month, the company signed a deal to supply doses of AstraZeneca’s vaccine hopeful from a facility in Anagni, Italy.
All of these deals were signed and put in motion before testing has proven any vaccine effective in protecting against the virus.
Moderna may be the first to start a late-stage, placebo-controlled trial with plans to study its vaccine candidate, mRNA-1273, in 30,000 people. The trial will measure first whether Moderna's product can prevent COVID-19 from developing after an infection.
Catalent will also support the clinical study, with supply services from a site in Philadelphia that include packaging, labeling, storage and distribution.