mRNA CDMO Service

Our company operates a cGMP-compliant RNA manufacturing facility, offering contract manufacturing services for investigational drugs (including research use) such as mRNA*1 and self-amplifying mRNA. Leveraging the RNA manufacturing expertise and know-how we have cultivated since our establishment in 2016, we aim to contribute to the stable supply of RNA pharmaceuticals in the Asia-Pacific region.

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Service Overview

  • We offer contract manufacturing services for mRNA intended for research and investigational drug use at our cGMP-compliant domestic facility.
  • Our support spans from mRNA design, including sequence design and modified nucleic acids, to manufacturing.
  • For the formulation of nucleic acid pharmaceuticals*2, including aseptic filling processes, we provide cGMP-compliant services for investigational drugs, typically ranging from 100 to 500 vials.

RNA Development and Manufacturing Contract (CDMO*3) Services

 

 

 

Features

  • Pioneering mRNA Technology - Manufacturing Capability for Diverse Applications
    We provide contract manufacturing services for advanced mRNA, including self-amplifying mRNA, and investigational drug mRNA essential for clinical development. Our flexible manufacturing system and stringent quality control support your innovative pharmaceutical development across various applications.
  • Ensuring RNA Pharmaceutical Quality - Advanced Quality Control Including NGS
    We conduct extensive quality evaluations, including RNA-specific quality control measures such as NGS (Next-Generation Sequencing) for sequence analysis. Our advanced analytical techniques and rigorous management system ensure the delivery of reliable, high-quality RNA to our clients. Our uncompromising commitment to quality drives the success of your product development.

 

 

Our Strengths

  • Delivering Assurance and Trust - Cutting-Edge cGMP-Compliant Domestic Manufacturing Environment
    Our domestic manufacturing facility, compliant with the pharmaceutical-grade quality standards of cGMP, is a testament to our commitment to quality. With advanced equipment and skilled technicians, we promise a stable supply of high-quality mRNA that meets your stringent requirements.
  • Proven Reliability - Extensive Experience and Track Record in mRNA Contract Synthesis
    As pioneers in mRNA design and contract synthesis, we have successfully led numerous projects to completion. Our extensive knowledge and advanced technical capabilities provide robust support for your mRNA research and development.
  • Relentless Pursuit of Quality - Advanced Technical Expertise Ensuring Reliable mRNA
    Our technical team continuously pursues the latest knowledge and technologies, maintaining a rigorous focus on quality from mRNA design, synthesis, and purification to quality evaluation. This advanced technical expertise is the reason we can deliver the highest quality mRNA products to our clients.
  • Flexible Customization to Meet Individual Client Needs
    We respond meticulously to the diverse needs of our clients with flexible customization. From mRNA design and synthesis scale to quality requirements, we carefully listen to your requests and provide the optimal solutions.

 

Participation in Collaborative Research and Projects

  • Contributing to Pioneering mRNA Drug Development - Invitation for Collaborative Research and Development
    Our company plays a central role in large-scale projects, such as those by the Japan Agency for Medical Research and Development (AMED), focusing on the mass synthesis, purification, and evaluation technology development of mRNA. We seek partnerships through active collaborative research with academia and pharmaceutical companies to contribute to the realization of new therapies.
  • Bringing the Latest Technology to Our Clients - Verification and Introduction Through Partnerships
    We collaborate with partner companies possessing innovative technologies in mRNA manufacturing and LNP formulation. These new technologies are rigorously evaluated under our stringent quality control system, ensuring our clients can confidently utilize cutting-edge mRNA design and synthesis services. By timely proposing optimal solutions, we robustly support our clients' research and development.

 

Delivery Record

Since the commencement of our business in 2021, we have executed multiple projects primarily for domestic clients, with delivery records extending to the United States as of September 2024.

In the 2023 satisfaction survey, we received high evaluations particularly for quality, delivery timelines, and customer responsiveness.

 

 

 

 

 

 

 

 

 

 

Key ItemsmRNA for ResearchmRNA for Clinical Trial
Manufacturing History DocumentProvision of CoAGMP Compliant
Manufacturing EnvironmentClean Environment (equivalent to ISO Class 7)mRNA Production: ISO class 7
Aseptic Filling: ISO class 5
Raw Material ManagementTraceable, Supplier ManagementTraceable, Supplier Management
Scale of Production200 μg - 100 mg100 mg - several g
Estimated Delivery TimeDiscussion of implementation: 0.5-1.0 months
Synthesis of mRNA*: 1.5-2.0 months

*May vary depending on implementation.		Please contact us for more information.

 

 

Facilities and Environment for mRNA for use in Clinical Trials

  • World-Class Quality Assurance - cGMP*4-Compliant Manufacturing Environment
    To deliver the highest levels of quality and safety to our clients, our manufacturing environment strictly adheres to cGMP (Current Good Manufacturing Practice) standards. We implement manufacturing process validation based on "Quality by Design" principles, ensuring consistent high quality.
  • Ensuring Data Integrity - 21 CFR Part 11*5-Compliant Electronic Document Management System (Web Audit Ready)
    Manufacturing records and quality data are rigorously managed using an electronic document management system compliant with 21 CFR Part 11. This ensures data reliability and transparency, with future readiness for web audits, providing peace of mind to our clients.
  • Rapid and Smooth Collaboration - Comprehensive Support System with Domestic Facilities
    By having manufacturing facilities in Japan, we achieve close communication and prompt responses with our clients. Leveraging geographical proximity, we provide meticulous support to accelerate your research and development.
  • Minimizing Contamination Risk - ISO Class 7 (Grade C) Compliant Clean Rooms
    RNA manufacturing is conducted in clean room environments compliant with ISO Class 7 (Grade C) standards. This minimizes the risk of contamination from particulates and microorganisms, ensuring the delivery of high-quality RNA products.
  • Strong Commitment to Sterility Assurance - Isolator-Based Filling System
    We utilize an isolator system with ISO Class 5 (Grade A) cleanliness for aseptic filling of RNA products. Through thorough sterility management, we provide products that clients can use with confidence.
  • Enhanced Quality Control System - Establishing GMP-Compliant Analytical Framework
    We are establishing a GMP-compliant quality control system to conduct various measurements, ensuring the quality of our clients' products (partially operational). By introducing the latest analytical technologies, we aim for more advanced quality evaluations.

RNA Manufacturing Room

Filling Room for Nucleic Acid Pharmaceuticals

Abbreviations Explanation

  • *1. mRNA: Abbreviation for messenger RNA, which carries nucleotide sequence information and structure that can be translated into proteins.
  • *2. Nucleic Acid Pharmaceuticals: Drugs based on natural or chemically modified nucleotides that act directly on the body without mediating gene expression. Representative nucleic acid pharmaceuticals include antisense oligonucleotides (ASO), miRNA, siRNA, and mRNA.
  • *3. CDMO Services: Abbreviation for Contract Development and Manufacturing Organization, which supports pharmaceutical formulation development and manufacturing.
  • *4. cGMP: Abbreviation for Current Good Manufacturing Practice, which are standards for manufacturing and quality control of pharmaceuticals and quasi-drugs.
  • *5. 21 CFR Part 11: Refers to "The Code of Federal Regulations Title 21 Food and Drugs Part 11, Electronic Records; Electronic Signatures" issued by the US FDA.

GMP-Compliant Quality Testing Services for mRNA Pharmaceuticals

We provide quality testing services for mRNA. Utilizing domestic facilities for mRNA-specific analytical items allows us to offer prompt and flexible responses.

 

Quality Control ItemsTest ContentsAnalytic Reasoning and Analysis
RNA IntegrityRNA Length Uniformity Using Capillary Gel ElectrophoresisCapillary Gel Electrophoresis
RNA ConcentrationCalculation of RNA concentration from
absorbance at 260 nm wavelength by measurement method based on the Japanese Pharmacopoeia		Ultraviolet Visual Absorbance Measurement (UV-Vis)　
RNA SequencesMeasure the percentage match with a reference sequenceSanger Sequence
Other, Characterization,
Analytical items in Bulk Pharmaceuticals for Injection, etc.		Perform various analyses at domestic facilities (contact
for details)

mRNA Manufacturing and Development Consulting Services

Drawing on our foundational mRNA manufacturing experience, we offer tailored solutions to enable the design of optimal structures for every region of your mRNA, ensuring compatibility with your specific mRNA delivery target cell type.

  • Improved stability against degradation by modified nucleic acid transfection

  • Improved translation efficiency by codon optimization

 

 

 

 

 

 

 

 

 

 

 

 

Example: Enhanced Degradation Resistance Through Modified Nucleic Acid Introduction

It is known that the optimal modified nucleic acids vary depending on the cell type. In human fibroblasts, strong GFP fluorescence was observed even after 8 days using synthetic GFP mRNA with modified nucleic acid A.