Moderna and Laboratorios Farmacéuticos Rovi have entered into a collaboration for large-scale, commercial fill-finish manufacturing of mRNA-1273, the former’s mRNA vaccine candidate against COVID-19, at the latter’s facility in Madrid, Spain.
Under the agreement terms, ROVI will offer vial filling and packaging capacity by procuring a new production line and equipment for compounding, filling, automatic visual inspection and labeling. This infrastructure development by the Spanish pharma company will support the production of hundreds of millions of doses of the mRNA-1273 vaccine candidate intended mainly to supply markets outside of the US beginning from early 2021, said Moderna.
ROVI will also recruit additional staffing needed for supporting manufacturing operations and production.
Juan Andres – Moderna Chief Technology Operations and Quality Officer said: “Moderna is committed to helping address the COVID-19 crisis. We are pleased to partner with ROVI to potentially supply hundreds of millions of doses of finished mRNA-1273, once approved, and help address the need for a vaccine against COVID-19 around the world.
“ROVI’s experience as a global manufacturer of drug product and expertise in fill-finish will be an important partnership for us to establish dedicated supply chains that can meet the needs of different countries and regions. I am delighted to be working with ROVI again.”
mRNA-1273 was selected by Moderna in partnership with investigators from Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Diseases (NIAID), which is a part of the National Institutes of Health (NIH). Recently, a phase 2 clinical trial of mRNA-1273 closed enrollment.
Moderna’s phase 3 study of nearly 30,000 participants, is expected to commence this month.
Juan López-Belmonte – CEO of ROVI said: “We are very happy about the collaboration with Moderna, whose vaccine against COVID-19 is one of the frontrunners in the race to solve this health crisis. We would be thrilled for ROVI to form part of the solution to this pandemic that is affecting all of us and to support Moderna in supplying it on a wide scale.
“Our proven experience and capabilities as a toll manufacturer of injectables has allowed us to reach this agreement, which would help strengthen our manufacturing area and would, in all probability, provide us with a significant growth opportunity in the area.”