Clinical & Commercial Oligonucleotide Manufacturing
With two synthesis platforms under one roof—solid-phase synthesis for scales from μg to several kg and AJIPHASE™ for sustainable production up to 200 kg—we offer flexible GMP oligonucleotide manufacturing solutions, supporting programs from process development through commercial supply.
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.
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
Transforming Every Stage of Development
One partner from first synthesis through commercial supply. Seamless platform selection, continuous process knowledge, and support at every scale.
Optimize Your Solution
From development through clinical and commercial supply, we support oligonucleotide programs with an integrated CMC workflow. Our teams begin with synthesis optimization, including coupling efficiency and deprotection conditions, to build a scalable and robust manufacturing process. We then develop downstream processes using purification strategies such as IEX, RP-LC, and UF/DF to achieve target purity and recovery.
Stability and Regulatory Support
We provide phase-appropriate analytical development, method validation, stability studies, and product characterization to support global regulatory requirements. Integrated CMC documentation and technical support help programs progress from clinical development through commercialization.
Quality and Certification
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. This quality foundation is backed by decades of oligonucleotide expertise, global GMP manufacturing, and scalable production capabilities.
200 kg
Max AJIPHASE™ synthesis scale per batch
8,000L
Largest reactor used in GMP manufacturing
25+
Years of oligo manufacturing experience
100
GMP batches manufactured
Manufacturing Facilities
Three GMP-capable sites across Belgium and Japan, providing geographic reach and manufacturing flexibility for global programs.
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, Japan
- 25+ years of oligonucleotide synthesis expertise
- PMDA audited
- Research-grade, process and analytical development, GMP, commercial solid-phase manufacturing
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
Request a GMP Oligonucleotide
Manufacturing Consultation
The right platform for every need — solid-phase, AJIPHASE™, and enzymatic ligation.
Frequently Asked Questions
What is the maximum scale for GMP oligonucleotide manufacturing at Ajinomoto Bio-Pharma Services?
Ajinomoto Bio-Pharma Services provides production scale up to 200 kg via AJIPHASE™ and up to 10 g via solid-phase synthesis — both available in GMP configuration. For PMO specifically, Aji Bio-Pharma operates one of the largest dedicated reactor capacities globally at 8,000 L.
What quality systems are in place for GMP oligo manufacturing at Ajinomoto Bio-Pharma Services?
Ajinomoto Bio-Pharma Services’ quality systems include GMP batch records, certificate of analysis (CoA) for every GMP batch, QA/QC oversight, ICH-compliant stability programs, and analytical method development and validation per ICH Q2. All methods are confirmed in-house.
Does Ajinomoto Bio-Pharma Services support IND CMC filing for oligonucleotide drug substances?
Yes, Ajinomoto Bio-Pharma Services provides process development, analytical characterization, and quality documentation to support IND CMC filings. Confirm the exact scope of CMC support with the Aji Bio-Pharma QA/RA team before finalizing your development plan.
What is the typical timeline for a GMP oligonucleotide manufacturing program at Ajinomoto Bio-Pharma Services?
Timeline depends on molecule complexity, modification type, required scale, and regulatory stage. Contact Ajinomoto Bio-Pharma Services’ oligonucleotide experts to tailor a milestone-based approach to your program.