Catalent has dedicated a high-speed vial filling line to Moderna at its site in Indiana, which it says will free up space for its non-COVID related customers.
The high-speed vial filling line expands upon an agreement inked between the two firms last June, and provides Moderna with a dedicated fill-finish service through to June 2023.
It will initially be used to manufacture Moderna’s COVID-19 vaccine, approved by the US FDA under an emergency use authorization (EUA) last December, though there is potential for it to produce other clinical products in the firm’s pipeline.
According to the contract development and manufacturing organization (CDMO), its Bloomington site has five filling lines, two of which are brand new following a $100 million investment in the site. One of these will be the dedicated Moderna line, while the other is dedicated to fellow COVID-19 vaccine client Johnson and Johnson (J&J) for its single-shot jab.
Despite two of the five lines being taken up by COVID-19 related projects, the CDMO told us by dedicating lines to these projects it actually frees up capacity for its other, non-COVID-related customers.
“In Bloomington, for instance, we have over one hundred customers, one hundred other [non-COVID] customer programs,” Bernie Clark, VP of global marketing and strategy at Catalent told BioProcess Insider.
“A lot of those are very important medicines that we’re making. And so, we’re dedicated not only to playing a major role in a solution to the pandemic [but] we’re also very mindful and obviously focused on continuing to produce other important medicine products and cancer related treatments to our other customers as well.”
Over ‘rated’ orders
As countries look to combat the current pandemic, production of COVID-19 vaccines has taken precedent over other programs, at least in the eyes of the US government, which has made a rated order for 300 million doses of the Moderna vaccine.
A rated order is an order or contract that takes priority over other orders, usually placed in support of a national defense program to meet specific delivery timeframes as is the case with COVID-19.
In dedicating a fill-finish line solely to Moderna, Clark said, “it frees up capacity on the existing lines for all of our other customers,” and “whether they need 100 million or one billion [doses] they have the capability reserved now which is really important to their company and pipeline going forward.”
Clark was unable to tell us a specific number of doses this dedicated line will produce. While The Wall Street Journal reported this line will able to fill an additional 80 million vials per year, Clark said the paper’s math was not quite correct.
“That was a maximum theoretical output on another line for a smaller single dose vial, and it wasn’t necessarily a vaccine.” He added: “This announcement is about [Moderna] securing high quality fill-finish capacity for the next two years for their vaccine and other products.”
To meet COVID-19 contractual demands, Catalent have hired over 1000 people at its Bloomington site to support a 24/7 manufacturing set-up needed to produce Moderna’s and J&J’s vaccines in large volumes. Clark praised the workforce and said “we couldn’t have done any of this without our people.”