Oligo Manufacturing

Oligonucleotide Manufacturing

We support oligonucleotide development and manufacturing from research through commercial scale by combining the broad modality support of solid-phase synthesis with the scalability of our proprietary liquid-phase technology, AJIPHASE™. Supported by scientific and regulatory expertise, manufacturing infrastructure, and flexible operations, we help customers move programs from early development to commercial supply.

Your Oligonucleotide Partner from Research to Commercial

From early development to commercial supply, we provide seamless manufacturing within a consistent quality framework. As programs scale, support stays with our experts, avoiding the need for a CDMO switch.

Research

Research Grade

We manufacture and supply ASOs, siRNAs, and a variety of modified oligonucleotides, produced under stringent quality specifications to support research programs that require reliable material.

Clinical

Clinical Phase

We provide a full-service offering spanning process and analytical development, from the first GMP batch through late-stage clinical programs, helping advance programs efficiently.

Manufacturing

Commercial Production

We support customers as a long-term API supply partner, planning and executing process characterization packages and PPQ activities required for regulatory approval.

Enabling a Wide Range of Specialized Oligo Development

We combine deep expertise in complex oligonucleotide chemistry, the scalability of the AJIPHASE™ synthesis platform, and global regulatory expertise to support efficient development, manufacturing, and commercialization across the oligonucleotide lifecycle.

Specialized Oligo

Custom DNA/RNA Oligonucleotides

Custom DNA synthesis for aptamers, molecular probes, diagnostics, and research applications.

Phosphorodiamidate Morpholino Oligonucleotides

Exon-skipping therapeutic programs for Duchenne muscular dystrophy (DMD).

Oligonucleotide Conjugates

Targeted delivery conjugates including GalNAc-ASO/siRNA, dye-labeled oligos, and antibody-oligonucleotide conjugates.

Antisense Oligonucleotides

Gene silencing and splice-switching programs from preclinical through commercial GMP supply.

Small Interfering RNA

RNAi therapeutics across research-grade through GMP clinical manufacturing scales.

MicroRNA Modulators

MicroRNA and antagomir synthesis for oncology and cardiovascular therapeutic programs.

Technology at a Glance

Based on each customer’s development stage, scale, and program needs, we recommend the optimal approach: Solid-Phase, AJIPHASE™ Synthesis, Enzymatic siRNA Synthesis, GenClip™ Long RNA Synthesis, or a tailored combination of platforms.

Solid-Phase Synthesis

Best for: Rapid Development

Scale Range: μg to several kg/batch

Key Advantage: Established platform, rapid development

AJIPHASE™ Synthesis

Best for: Large-Scale Manufacturing

Scale Range: Grams to 200 kg/batch

Key Advantage: Scalable and sustainable manufacturing

Enzymatic siRNA Synthesis

Best for: Complex & longer structures

Scale Range: Grams to tons

Key Advantage: Higher purity and yield with reduced PMI

GenClip™ Long RNA Synthesis

Best for: sgRNA, pegRNA, and mRNA

Scale Range: μg to Grams

Key Advantage: Maintains high yield and quality for long RNA

Quality, Expertise, and Manufacturing Scale

Our quality systems support GMP operations through controlled batch record documentation and QA/QC oversight. We also support stability programs designed in accordance with ICH guidelines and provide CMC regulatory support throughout the product lifecycle, including documentation, technical input, and data packages for IND, NDA, and BLA submissions. This quality foundation is backed by decades of oligonucleotide expertise, global GMP manufacturing, and scalable production capabilities.

Manufacturing Facilities

Wetteren Facility

Wetteren, Belgium

  • Scale from grams to 200 kg/batch
  • GMP manufacturing experience with AJIPHASE™
  • Designed for efficient scale-up and commercial manufacturing
  • Seamless process and analytical development across all stages
Osaka Facility

Osaka, Japan

  • 25+ years of oligonucleotide synthesis expertise
  • PMDA audited
  • Research-grade, process and analytical development, GMP, commercial solid-phase manufacturing
Tokai Facility

Tokai, Japan

  • Scale from grams to 200 kg/batch
  • GMP manufacturing experience with AJIPHASE™
  • FDA and PMDA audited
  • Seamless process and analytical development across all stages

Oligonucleotide Products & Consumables

We offer a range of oligonucleotide-related products and services to support research and development needs.

Custom Synthesis

Custom Synthesis Products

Order directly or through your distributor based on your quotation. If you do not yet have a quotation, complete the request form to get started.

Clinical

Clinical Trial Products

Submit an inquiry with your product needs. Our team will review your request and guide you through the next steps.

miRNA

miRNA Design Products

Provide the miRNA ID or number, required quantity, and purification grade through the inquiry form. Once you receive a quotation, place your order directly or through your distributor.

CpG-ODN

CpG-ODN Solutions

Specify the CpG type and quantity you require through the inquiry form. Once you receive a quotation, place your order directly or through your distributor.

Econospin

Life Science Products

For sample requests, submit the product number through the inquiry form. To place an order, contact your distributor with the product number and required quantity.

Let’s Discuss Your Oligonucleotide Program

From first synthesis to commercial supply — one partner, the right platform, every scale.

Frequently Asked Questions

What oligonucleotide types can Ajinomoto Bio-Pharma Services manufacture at GMP scale?

Ajinomoto Bio-Pharma Services supports GMP manufacturing for a broad range of oligonucleotides, including ASOs, siRNAs, oligonucleotide conjugates, and other modalities. They can also support sgRNA manufacturing. If you have a specific modality or design in mind, contact the Aji Bio-Pharma team to discuss the best manufacturing approach for your program.

What is AJIPHASE™ and how does it differ from traditional solid-phase oligonucleotide synthesis?

AJIPHASE™ is Ajinomoto Bio-Pharma Services’ proprietary liquid-phase synthesis technology for oligonucleotides and peptides. Instead of the resin used in solid-phase synthesis, AJIPHASE™ uses a proprietary soluble anchor, enabling highly efficient reactions, simpler scale-up, and robust process control.

What is the maximum scale for GMP oligonucleotide synthesis at Ajinomoto Bio-Pharma Services?

For solid-phase, Ajinomoto Bio-Pharma Services supports manufacturing from μg to kg per batch scale. With AJIPHASE™, Aji Bio-Pharma can support production up to 200 kg per batch, with larger-scale options available. This flexible platform allows Aji Bio-Pharma to match the manufacturing approach to your development stage and commercial needs.

Can Ajinomoto Bio-Pharma Services support both non-GMP research synthesis and GMP clinical manufacturing?

Yes. Ajinomoto Bio-Pharma Services supports programs from small-scale non-GMP material for early research use through GMP manufacturing for clinical development and beyond. With capabilities across multiple production scales, Aji Bio-Pharma provides a seamless handoff from early to late development stage, allowing you to work with a single partner throughout your program.

What modified oligonucleotide chemistries does Ajinomoto Bio-Pharma Services support?

Ajinomoto Bio-Pharma Services supports a wide range of modified oligonucleotide chemistries, including commonly used modifications such as PS, 2′-F, 2′-OMe, 2′-MOE, LNA, and cEt. Aji Bio-Pharma also has experience with chemistries such as BNA, AmNA, GuNA, 5′-CP, and 5′-VP. For more complex modification options, contact the Aji Bio-Pharma team.

Does Ajinomoto Bio-Pharma Services support IND CMC filing for oligonucleotide drug substances?

Yes. Drawing on experience from more than 50 GMP manufacturing campaigns and extensive support for programs advancing from preclinical to early clinical stages, Ajinomoto Bio-Pharma Services can support IND CMC activities for oligonucleotide API. Aji Bio-Pharma’s services include quality design, process and analytical development, and preparation support for IND-related documentation.

Can Ajinomoto Bio-Pharma Services manufacture oligonucleotide conjugates, including GalNAc and AOC?

Yes. Ajinomoto Bio-Pharma Services supports the manufacture of oligonucleotide conjugates, including GalNAc-conjugated oligonucleotides and AOC programs. For AOCs, Aji Bio-Pharma can support both AJICAP™, proprietary site-specific conjugation technology, and conventional random conjugation approaches, depending on program needs.