Catalent Inc. and Arcturus Therapeutics Holdings Inc. of California on Monday announced a partnership to support the expected manufacture of Arcturus’ COVID-19 mRNA vaccine candidate (LUNAR-COV19).
Monday’s partnership will see the LUNAR-COV19 vaccine manufactured at Catalent’s drug substance biomanufacturing facility in Madison, Wis. Human clinical studies will also be conducted at that facility band, if successful, the vaccine will be commercialized.
The COVID-19 vaccine program will take advantage of the facility’s flex-suite, a cGMP manufacturing suite that can produce batches at multiple scales and support Arcturus’ proprietary mRNA manufacturing process.
The announcement comes on the heels of Somerset-based Catalent announcing a collaboration with Janssen Pharmaceutical Cos. of Johnson & Johnson to accelerate the availability of manufacturing capacity, and prepare for large-scale commercial manufacturing, for that company’s lead COVID-19 vaccine candidate.
According to Catalent and Arcturus, the partnership will combine the latter’s low-dose STARR mRNA vaccine technology with the former’s scalable cGMP manufacturing capabilities to produce millions of doses of LUNAR-COV19 mRNA in 2020 and potentially hundreds of millions of doses annually for worldwide use.
Preparations for this program have already begun at the Madison facility, and both organizations say they are committed to meeting the global demand on unprecedented manufacturing timelines. Technology transfer will be completed this month and manufacture of the first cGMP batches of LUNAR-COV19 mRNA are expected to be completed by June 2020.
“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.”