ARCALIS, Inc.

After completion of its DS facility in Minamisoma, Fukushima Prefecture in August 2023, ARCALIS, Inc. transferred from the US to Japan, Kostaive, the world’s first approved sa mRNA vaccine, in a record time: 12 months from IQOQ to PPQ completion. In March 2026, ARCALIS inaugurated its Drug Product Facility enabling it to fill aseptic vials and lyophilized drug product. Drawing on its experience in mRNA vaccines, ARCALIS is now supporting pre-clinical programs to move into GMP manufacturing for First In Human trials.