Moderna signs agreement with Lonza for production of new drug substance

Moderna announced that it has entered into an additional agreement with Lonza to support drug substance manufacturing for its global supply chain. The agreement will establish a new production line at Lonza’s Geleen site in the Netherlands, contributing to the supply of an additional 300 million doses of Moderna’s updated booster variant vaccine candidate, if authorised, per year, at a 50 µg dose.

“In addition to previously announced investments in drug substance manufacturing with ROVI in Granada, Spain, the company now expects to be able to supply the equivalent of 600 million 50 µg doses per year from production within the European Union. Both new drug substance lines in the European Union are expected to be operational before the end of 2021,” said a statement from the company.

“We thank our manufacturing partners for their work and their commitment and are proud to be building on the strong foundations we have established with Lonza to further increase our manufacturing capabilities in Europe. This additional production will help us continue to scale up our production as we continue to develop best-in-class variant boosters so we can help end this pandemic as fast as possible,” said Juan Andres, Moderna’s Chief Technical Operations and Quality Officer.

Moderna already works with ROVI and Recipharm (France) for fill/finish of COVID-19 Vaccine Moderna in Europe and recently entered into a Manufacturing Services and Supply Agreement with Samsung Biologics in South Korea to provide additional large scale, commercial fill/finish services. In the US, the company also works with Lonza Portsmouth for drug substance production, and partners with Catalent, Baxter BioPharma Solutions, Sanofi and Thermo Fisher Scientific for fill/finish services.

“Additional manufacturing investments follow the company’s commitment to increase production in late 2021 and early 2022 to support global supply of its COVID-19 vaccine,” the company said.

When completed, the increased production, in addition to other investments at its owned and partnered manufacturing facilities, is expected to also result in an increase in safety stock of raw materials and finished product used to deliver committed volumes.