Moderna Mobilizes CDMOs for Covid Shot Ramp-up

04.06.2021 - As it ramps up production on three continents, US Covid-19 vaccine manufacturer Moderna is expanding its collaborations with CDMO suppliers in Europe, the US and Asia. At the beginning of June, the US biotech announced new supply agreements with Lonza and Thermo-Fisher. In late May, it inked new deals with Aldevron and Samsung Biologics in Asia to handle various stages of the mRNA shot’s production.

Lonza Building new Drug Substance Line at Geleen

Expanding its work with Moderna, Swiss CDMO Lonza is building a new drug substance production line at its site in Geleen, the Netherlands. The Basel-based company, Moderna’s principal European production partner, said the new line, which will have capacity for 300 million 50 μg doses annually, will complement its existing production network for the shot and deliver a “crucial manufacturing step to increase overall drug substance output.”

Production at Geleen is due to start by the end of 2021. Lonza said it will leverage its existing infrastructure at the Dutch site to provide fast buildout and ramp-up of operations. As part of its 10-year strategic collaboration with the US company, Lonza has installed three production lines at Visp, Switzerland, and one at its US site in Portsmouth, New Hampshire. In April this year, the partners signed a new agreement to add three more Covid vaccine lines at Visp.

Thermo-Fisher Scientifc to Handle US Fill & Finish

In the US, Thermo-Fisher Scientifc is also stepping up its cooperation with Moderna on the Covid vaccine. Under the new agreement, Thermo-Fisher will use its commercial manufacturing site in Greenville, North Carolina, to handle fill & finish, labeling and packaging for “hundreds of millions of doses.” Production will begin in the third quarter of 2021.

“Thermo Fisher has been a critical partner in supplying raw materials for our Covid-19 vaccine and we are now pleased to further expand our relationship as an important manufacturing partner as well,” said Juan Andres, Moderna’s chief technical operations and quality officer.

Aldevron to Supply Plasmid DNA for Vaccine

US-based Aldevron, which sees itself as “the leading provider of high-quality plasmid DNA, mRNA and recombinant proteins for vaccines, gene and cell therapy, gene editing and diagnostic applications,” has expanded its collaboration with Moderna to support the Covid-19 Vaccine and additional programs in the US biotech’s clinical development pipeline. The CDMO will supply plasmid DNA to serve as the genetic template for generating the vaccine and other investigational programs.

Aldevron’s production of DNA continues to take place at its GMP facility in Fargo, North Dakota. Buildout and validation of an additional expansion to the GMP facility on Aldevron’s 14-acre Breakthrough Campus has been completed, the company said.

Samsung Biologics Handling Asian Fill &Finish

To cover Asia, Moderna has sealed a pact with South Korean CDMO Samsung Biologics to perform large-scale, commercial fill-finish duties for the Covid vaccine at its facilities in in Incheon, South Korea. Once the deal closes, the companies said technology transfer will begin "immediately.”

The Samsung group company said it plans to leverage an existing finishing, labeling and packaging line to produce "hundreds of millions" of vaccine doses for countries outside the US from this year’s third quarter. CEO John Rims said that, “due to the high level of urgency in supplying the vaccine to the global population, we have set immediate action plans and schedule to make mRNA-1273 available for commercial distribution in the early second half of 2021.”

On the same day as it inked the agreement with Samsung Biologics, Moderna signed two Memoranda of Understanding (MoU) with the government of South Korea covering collaboration on mRNA vaccine research and exploration local manufacturing opportunities for these vaccines in South Korea.

Author: Dede Williams, Freelance Journalist