As researchers race to develop a vaccine for COVID-19, production on one potential single-shot vaccine is underway at Catalent, Inc.’s biomanufacturing facility in Madison.
Somerset, New Jersey-based Catalent and San Diego-based Arcturus Therapeutics Holdings Inc. are partnering to manufacture a COVID-19 mRNA vaccine candidate at Catalent Biologics’ 103,000-square-foot facility, located at 726 Heartland Trail in Madison.
The vaccine utilizes Arcturus’ self-transcribing and replicating mRNA technology and its lipid-mediated delivery to produce an “extraordinarily low dose” vaccine, according to the companies.
It is just one of several COVID-19 vaccine development projects happening around the world. There is no guarantee that any of them will be proven to be effective at protecting people from the virus and safe for human use. But some vaccine developers, including Catalent and Arcturus, are working to mass produce the vaccine that they are developing in hopes that it will be proven to be effective and safe, will be approved by the government for use and can then be made available to the public as soon as possible.
The first batches of the COVID-19 mRNA vaccine are expected to be completed this month. The companies said they plan to produce millions of doses of LUNAR-COV19 mRNA in 2020 and potentially hundreds of millions of doses annually for worldwide use.
The vaccine program is taking advantage of the Catalent facility’s flex-suite, a cGMP manufacturing suite that can produce batches at multiple scales and support Arcturus’ mRNA manufacturing process, the companies said.
“Catalent is proud to partner with Arcturus in the pursuit of a vaccine that could protect people against the coronavirus pandemic,” said John Chiminski, chair and chief executive officer of Catalent. “Our unique experience and flex-suite cGMP capacity will enable rapid scale-up of Arcturus’ proprietary manufacturing process to make the vaccine available as soon as possible.”
In January 2019, Catalent announced a $75 million investment in its Madison facility over the next three years that will more than double its commercial biomanufacturing capacity. The company opened the facility – which specializes in development, manufacturing and analytical services for new biological entities and biosimilars – in 2013. Work on the expansion is expected to be completed by mid-2021.