2023.08.04 Press Release

ARCALIS – Notice of Completion of New mRNA Drug Substance Plant

ARCALIS Inc. (headquartered in Minamisoma City, Fukushima Prefecture; hereinafter “ARCALIS”) is pleased to announce that its new mRNA Drug Substance Plant (hereinafter “NEW PLANT”) under construction in Minamisoma City, Fukushima Prefecture was completed on July 31st, 2023, and a completion ceremony was held today, August 4th, 2023.

The NEW PLANT will meet the current Good Manufacturing Practice (cGMP) standards and has been equipped with the world’s most advanced manufacturing and quality control systems. We are committed to meeting a variety of customers’ demands.


NameARCALIS Minamisoma Drug Substance Plant
Address320-20 Kawauchisako, Shimoota aza, haramachi, Minamisoma, Fukushima, 975-0041
StructureSteel frame, 5 floor, seismically isolated (36 meters)
Building Area1933 m2
Total floor space7252 m2
Outline of Plant FacilitiesEquipped with the manufacturing facilities necessary to produce mRNA, a cutting-edge pharmaceutical product, for overseas use in compliance with cGMP
Manufacturing ItemsmRNA and LNP in bulk
Production CapabilityUp to 5 kg of Drug Substance per year in bulk
Estimated launch date of full-scale operationAugust 2023
Construction, design and management in chargeObayashi Corporation


ARCALIS is an mRNA vaccines and therapeutics contract development and manufacturing organization (“CDMO”), jointly established by Axcelead, Inc. (President & CEO, Yoshinori Ikeura, hereafter, Axcelead) and Arcturus Therapeutics, Inc. (NASDAQ: ARCT/hereafter, Arcturus). ARCALIS aims to develop the world’s first mRNA vaccines and therapeutics CDMO business that promises a stable supply of high-quality mRNA medicines to all customers, including pharmaceutical companies, biotech companies, and academic

institutes worldwide. The new facility in the city of Minamisoma (Fukushima Prefecture) is equipped with state-of-the-art manufacturing and quality control systems that meet the cGMP standards for pharmaceuticals.


2.Future Vision of Minamisoma Plant

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