Therapy Areas: AIDS & HIV
Moderna Inks New Drug Substance Production Agreement with Lonza in the Netherlands
3 June 2021 - - US-based biotechnology company Moderna, Inc. (NASDAQ: MRNA) has entered into an additional agreement with Lonza (SIX: LONN) to support drug substance manufacturing for its global supply chain, the company said.

The agreement will establish a new production line at Lonza's Geleen site in the Netherlands, contributing to the supply of an additional 300m doses of Moderna's updated booster variant vaccine candidate, if authorized, 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 m 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.

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.

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.

The COVID-19 Vaccine Moderna (referred to in the US as the Moderna COVID-19 Vaccine) is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and investigators from the National Institute of Allergy and Infectious Diseases' (NIAID) Vaccine Research Center.

The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020 and underwent analytical testing; it was shipped to the National Institutes of Health on February 24, 42 days from sequence selection.