Minamisoma City, Fukushima, Japan – May 21, 2026 – ARCALIS, Inc. (“ARCALIS”) announces that it has been selected for the “Vaccine and New Modality Research and Development Program (Open Call)” launched by the Japan Agency for Medical Research and Development (AMED) through its Strategic Center of Biomedical Advanced Research and Development for Preparedness and Response (SCARDA). The selected research and development project is titled: “Development of cell-free manufacturing technology for the DNA templates of mRNA vaccines enabling rapid domestic production during Infectious disease emergencies.”

Currently, all commercially available mRNA vaccines, including COVID-19 vaccines, are manufactured using plasmid DNA amplified in E. coli as templates. However, plasmid-based templates present several challenges, including lengthy manufacturing timelines due to requirements such as E. coli culture and regulatory compliance under the Cartagena Act, as well as high production costs arising from the limited availability of GMP-compliant manufacturing facilities. In particular, during a pandemic, extremely rapid vaccine production is required, and procurement of template DNA can become a critical bottleneck. Through this project, ARCALIS aims to establish a “cell-free” template manufacturing technology that does not rely on E. coli.

“We believe that one of the processes with the greatest potential for shortening development timelines in mRNA vaccine production is the preparation of template DNA,” said Satoshi Takamatsu, Ph.D., Representative Director, President & CEO of ARCALIS. “As an mRNA CDMO with commercial manufacturing experience in mRNA vaccines, we identified the challenges associated with plasmid-based templates at an early stage and began developing alternative technologies. Establishing a fully cell-free template manufacturing technology through this project will significantly improve the speed and efficiency of mRNA vaccine production. ARCALIS remains committed to contributing to the rapid domestic manufacturing of vaccines and delivering them to people around the world.”

<About ARCALIS>
ARCALIS is Japan’s first mRNA CDMO headquartered in Minamisoma. In July 2023, we completed our drug substance manufacturing facility at the Minamisoma site and have since successfully commenced commercial production and shipment of mRNA vaccine drug substances. In February 2026, we further expanded our manufacturing capabilities with the completion of a drug product facility adjacent to the drug substance building, enabling rapid domestic production of infectious disease vaccines during public health emergencies. We provide seamless, end-to-end services for mRNA vaccines and therapeutics — from process development to commercial manufacturing — for pharmaceutical companies and biotech ventures in Japan and around the world.

For more information, please visit https://corp.arcalis.co.jp/en/