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 expertise, regulatory 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 within Aji Bio-Pharma Services, avoiding the need for a CDMO switch.
Research Grade
At Aji Bio-Pharma, we manufacture and supply ASOs, siRNAs and variety of modified oligonucleotides, produced under stringent quality spec to support research programs that require reliable material.
Clinical Phase
Aji Bio-Pharma provides a full-service package spanning manufacturing, process and analytical development, from the first GMP batch through late-stage clinical programs, helping advance candidates efficiently.
Commercial Production
Aji Bio-Pharma supports 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 infrastructure to support efficient development, manufacturing, and commercialization across the oligonucleotide lifecycle.
Custom DNA/RNA Oligonucleotides
Custom DNA synthesis for aptamers, molecular probes, diagnostics, and research applications.
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 cGMP 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.
Phosphorodiamidate Morpholino Oligonucleotides
Exon-skipping therapeutic programs for Duchenne muscular dystrophy (DMD).
Technology at a Glance
Based on each customer’s development stage, scale, and program needs, we recommend the optimal approach: Solid Phase, AJIPHASE™, Enzymatic Synthesis, or a tailored combination of platforms.
Quality & Global Network
Our quality systems support cGMP operations through controlled batch record documentation and QA/QC oversight. We also support stability programs designed in accordance with ICH guidelines and can contribute to IND CMC support data packages, including documentation and technical input.
25+
Years Oligo synthesis expertise
3
cGMP Sites across Belgium & Japan
200kg
Max AJIPHASE™ synthesis scale
8,000L
PMO reactor capacity
Manufacturing Facilities
Three GMP-capable sites in Japan and Belgium, providing geographic and regulatory redundancy for global programs.
oligo synthesis
Osaka, Japan
- 25+ years of oligonucleotide synthesis expertise
- PMDA audited
- Full solid-phase cGMP capabilities
AJIPHASE™ Production
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
Commercial API production
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
Oligonucleotide Products & Consumables
We offer a range of oligo-related products and services to support research and development needs. Together, these offerings support a wide range of research and development activities. Our current lineup includes:
Custom Synthesis Products
Place your order either directly or through your distributor based on our quotation. Without a quotation: Download and complete the request form, then place your order either directly or through your distributor.
Clinical Trial Products
Contact us through the inquiry form. Our team will review your request and provide guidance on the next steps.
miRNA Design Products
Prepare the miRNA ID/number, required quantity, and purification grade. Place your order directly or through your distributor based on the quotation. Send the information through the inquiry form, either directly or via your distributor.
CpG-ODN Solutions
Specify the type of CpG you require. Send your inquiry through the inquiry form, either directly or via your distributor. Place your order based on our quotation. Without a quotation: Specify the type of CpG you require, and place your order either directly or through your distributor.
Life Science Products
For a sample request: Send the product number through the inquiry form. To place an order contact your distributor with the product number and 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 you manufacture at GMP scale?
We support GMP manufacturing for a broad range of oligonucleotide modalities, including ASOs, siRNAs other modalities, and oligonucleotide conjugates. We can also support sgRNA manufacturing. If you have a specific modality or design in mind, please contact us 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?
For solid-phase, we support manufacturing from μg to kg per batch scale. With AJIPHASE™, we can support production up to 200 kg per batch, with larger-scale options. This flexible platform allows us to match the manufacturing approach to your development stage and commercial needs.
Can you support both non-GMP research synthesis and GMP clinical manufacturing?
Yes. We support 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, we provide a seamless handoff from early to late development stage, allowing you to work with a single partner throughout your program.
What modified oligonucleotide chemistries do you support?
We support a wide range of modified oligonucleotide chemistries, including commonly used modifications such as PS, 2′-F, 2′-OMe, 2′-MOE, LNA, and cEt. We also have experience with chemistries such as BNA, AmNA, GuNA, 5′-CP, and 5′-VP. For more complex modification options, please contact us or refer to our Complex Modified Oligos page.
Do you 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, we can support IND CMC activities for oligonucleotide API. Our services include quality design, process and analytical development, and preparation support for IND-related documentation.
Can you manufacture oligonucleotide conjugates, including GalNAc and AOC?
Yes. We support the manufacture of oligonucleotide conjugates, including GalNAc-conjugated oligonucleotides and AOC programs. For AOCs, we can support both AJICAP™, our proprietary site-specific conjugation technology, and conventional random conjugation approaches, depending on program needs.