ARCALIS is a Japan based global contract development and manufacturing organization (CDMO) dedicated to advancing messenger RNA (mRNA) vaccines and therapeutics across preclinical, clinical, and commercial stages. 

Founded in 2021 by Axcelead, Inc. and Arcturus Therapeutics, ARCALIS was established to meet the growing demand for high quality and scalable mRNA development and manufacturing.

ARCALIS supports a broad range of mRNA applications in infectious diseases, rare diseases, oncology, regenerative medicine, and gene editing. Our capabilities include early research support, mRNA sequence design, analytical and CMC development, GMP manufacturing, and quality systems built specifically for mRNA based products.

The company has developed its own internal technologies and process development platforms that enable reliable, scalable, and compliant mRNA manufacturing. In 2025, ARCALIS received PMDA approval for the world’s first Sa mRNA vaccine produced at its facility, making it one of the few CDMOs with hands on experience in commercial stage mRNA manufacturing.

Based in Minamisoma, Fukushima, Japan, ARCALIS operates a state of the art manufacturing facility specializing in mRNA drug substance, LNP formulation, and fill and finish, supporting programs from clinical Phase 1 through commercial production. With a focus on quality, innovation, and regulatory readiness, ARCALIS partners with global pharmaceutical and biotechnology companies to accelerate the delivery of next generation mRNA medicines to patients worldwide.

ARCALIS, Inc.

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