OR WAIT null SECS
Catalent will manufacture a mRNA-based COVID-19 vaccine for clinical trials and potential commercialization.
Catalent announced, on May 4, 2020, an agreement to manufacture the drug substance for human clinical trials and potential commercial manufacture of Arcturus Therapeutics’ COVID-19 mRNA vaccine candidate (LUNAR-COV19),
The vaccine candidate uses Arcturus’ self-transcribing and replicating mRNA (STARR) technology and its LUNAR lipid-mediated delivery to produce a low-dose, potential single-shot COVID-19 vaccine, the company reports.
On April 27, 2020, Arcturus reported positive immunogenicity data from a preclinical study measured by Duke-NUS Medical School in Singapore, which the researchers said, support the initiation of human clinical trials in the summer of 2020.
Catalent will manufacture LUNAR-COV19 at its drug substance biomanufacturing facility in Madison, WI to support human clinical studies and, potentially, commercial manufacturing. The facility’s current good manufacturing practice (cGMP) flex-suite can produce batches at multiple scales and support Arcturus’ proprietary mRNA manufacturing process, Catalent reported in a press statement.
The companies reported plans to produce millions of doses of LUNAR-COV19 mRNA in 2020 and potentially hundreds of millions of doses annually for worldwide use. Technology transfer will be completed in May 2020, 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 in the press statement. “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.”
“Government agencies and foundations are securing rights and access to vaccines being developed to protect their respective populations,” Joseph Payne, president and CEO of Arcturus, stated in the press statement. “The Catalent Biologics team and their high-tech Madison facility is ideally suited to manufacture a substantial number of doses. Arcturus will be better positioned to supply these entities with our COVID-19 vaccine candidate on an accelerated basis with Catalent as our manufacturing partner.”