A triumvirate of CDMO expansions will increase production of Moderna’s COVID-19 vaccine: Lonza will repurpose a suite at a Dutch facility to up drug substance, and Aldevron will increase plasmid DNA supply. Meanwhile, Thermo Fisher will provide fill/finish capacity from North Carolina, as will Samsung Biologics from korea.
Last month, Moderna announced plans to increase both internal and third-party production of its mRNA COVID-19 vaccine, currently being rolled out under an FDA Emergency Use Authorization (EUA).
This included making an investment at contract development and manufacturing organization (CDMO) Lonza to double drug substance manufacturing from its plant in Visp, Switzerland.
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Moderna has further expanded its deal with Lonza this week, with an agreement to establish a production line at Lonza’s Geleen site in the Netherlands. Once operational (expected by the end of the year), the line will produce an additional 300 million doses of Moderna’s updated booster variant vaccine candidate, if authorized, per year, at a 50 µg dose.
Combined with the recently announced expansion at CDMO Rovi in Granada, Spain, Moderna expects to be able to produce 600 million doses per year. Then of course there are the hundreds of millions of doses being produced from Visp, Lonza’s Portsmouth, New Hampshire site, and Moderna’s own facility in Norwood, Massachusetts.
“The Geleen site is part of our cell and gene therapy manufacturing network. An existing suite will be repurposed at Lonza Geleen (NL) to manufacture drug substance for COVID-19 Vaccine Moderna,” Lonza spokeswoman Martina Ribarhestericova told BioProcess Insider.
Lonza added the Geleen site as part of its acquisition of PharmaCell B.V in 2017, which added European advanced therapy manufacturing capabilities to the global CDMO’s offering.
Thermo Fisher
In a separate deal, Moderna has secured fill/finish manufacturing services and supply packaging for hundreds of millions of doses of the vaccine at Thermo Fisher’s Greenville, North Carolina site.
Details remain sparse, but the site s expected to begin production in the third quarter this year.
“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,” Juan Andres, Moderna’s CFO said in a statement.
“The addition of Thermo Fisher to our network will support our efforts to scale up our manufacturing ability.”
Thermo Fisher picked up the Greenville site as part of its $7.2 billion acquisition of Patheon in August 2017. The firm has since invested heavily to increase capacity at the facility.
Samsung Biologics
The Thermo Fisher news comes straight off the bat of Moderna inking a deal with Korean CDMO Samsung Biologics for the large scale, commercial fill/finish manufacturing of its COVID-19 vaccine.
From the third quarter, Samsung Biologics will carry out aseptic fill/finish, labeling, and packaging services to support the production of hundreds of millions of doses for the supply of markets outside the US.
Aldevron
The fourth CDMO deal saw Moderna expand its partnership with plasmid DNA supplier Aldevron.
The expansion – no financials available – will see Aldevron supply plasmid DNA to serve as the genetic template for generating the COVID-19 mRNA vaccine and other investigational programs in Moderna’s pipeline.
DNA production takes place from its facility in Fargo, North Dakota, which has recently undergone an 189,000 square-foot expansion.
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