GMP Manufacturing Services for mRNA and LNP

  • GMP Manufacturing Services for mRNA and LNP 1
  • GMP Manufacturing Services for mRNA and LNP 2
Product Description

ARCALIS provides GMP-compliant manufacturing of mRNA and LNP formulation services, including commercial-scale production. With its facilities in Minamisoma, Japan, ARCALIS supports flexible batch sizes, technology transfer, and regulatory documentation. Notably, ARCALIS was selected as the manufacturing partner for KOSTAIVE®, the first self-amplifying mRNA (saRNA) COVID-19 vaccine approved in Japan, demonstrating its capability in commercial production of next-generation mRNA vaccines.

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ARCALIS, Inc.

  • Country/Region:
    Japan
  • On CPHI since:
    2024
  • Certificates:
    1
  • Employees:
    100 - 249
Company types
CMO/CDMO
Primary activities
Contract Manufacturer
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Categories
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Specifications
  • Details
    • GMP mRNA drug substance (DS) manufacturing
    • LNP bulk production 
    • Fill & Finish (starting 2026) 
    • Manufacturing scale:
      　・mRNA: Up to 80 g/batch
      　・LNP: 50–500 mL/min flow rate
      　・Filling: 2 million lyophilized vials/year
  • Selling Points
    Convenience; Experienced Technicians; Product Performance; Quality Service;
    • Japan’s first end-to-end mRNA CDMO 
    • Successfully manufactures sa-mRNA COVID-19 vaccine (KOSTAIVE®) 
    • Facilities compliant with PIC/S GMP standards 
    • Track record of technology transfer with validated protocols
  • Supplied from
    Japan
More specifications Fewer specifications

ARCALIS, Inc.

  • Country/Region:
    Japan
  • On CPHI since:
    2024
  • Certificates:
    1
  • Employees:
    100 - 249
Company types
CMO/CDMO
Primary activities
Contract Manufacturer
View company profile

More Products from ARCALIS, Inc. (1)

  • Non-GMP mRNA Development & CMC Services

    Product Non-GMP mRNA Development & CMC Services

    ARCALIS provides a fully integrated, end-to-end R&D support service for early-stage mRNA drug discovery. The service includes sequence design with proprietary AI-driven codon optimization algorithms, mRNA manufacturing, LNP formulation, and evaluation using in vitro/in vivo studies. 

ARCALIS, Inc. resources (1)

  • ARCALIS's Corporate Short Film

    Video ARCALIS's Corporate Short Film

    Who is ARCALIS? Take a quick look into our world—where science meets innovation to create next-generation mRNA medicines. This short film gives you a glimpse of our people, passion, and progress in revolutionizing drug manufacturing.
    2025-04-21