Rovi has joined the list of CDMOs that will make Moderna’s coronavirus vaccine candidate if it is approved.
Rovi – also known as Laboratorios Farmacéuticos Rovi – will provide commercial fill-finish and packaging services for mRNA-1273 at its facility in Madrid, Spain under a contract announced last week.
Moderna said Rovi would support production of hundreds of millions of doses to supply markets outside of the US starting in early 2021. The US firm also said ROVI would hire extra manufacturing operations and production staff.
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This was confirmed by ROVI spokeswoman Patricia Cobo Sanchez, who declined to provide details of the hiring plan citing “the confidential agreement signed with Moderna.”
The CDMO will increase capacity to service the contract. Sanchez told us “ROVI will acquire a new production line and equipment for compounding, filling, automatic visual inspection and labeling to support production of hundreds of millions of doses of the vaccine candidate.”
Sanchez also confirmed Moderna will pay Rovi for its services.
Supply chain
Moderna is developing mRNA-1273 in collaboration with investigators at the Vaccine Research Center (VRC) of the National Institute of Allergy and Infectious Diseases (NIAID).
Enrolment in a Phase II study of the vaccine was completed last week according to Moderna, which has said it plans to start a Phase III trial involving up to 30,000 participants this month.
Contract support
Moderna signed a separate fill-finish and packaging deal with Catalent in June.
Under that contract, Catalent will provide clinical supply services from its facilities in Philadelphia, Pennsylvania, including packaging and labeling, as well as storage and distribution.
If the vaccine is approved Catalent will also provide filling and packaging capacity at its Bloomington, Indiana plant for an initial 100 million doses for the US market starting in the third quarter of 2020.
In addition to fill-finish, Moderna is also using contractors to bolster production of the vaccine.
In May it announced Lonza as a production partner, explaining the plan is to establish manufacturing suites at the CDMOs facilities in the US and Switzerland for the manufacture of mRNA-1273.
At the time Moderna said Lonza would start making mRNA-1273 at its site in New Hampshire in July.
CDMO
The role the CDMO sector is playing in the production of Moderna’s coronavirus vaccine candidate and others was highlighted by industry group PBOA.
PBOA president Gil Roth said CDMO capacity would be key to helping meet global demand during a recent Duke-Margolis Center for Health Policy webinar.