Clinical & Commercial Oligonucleotide Manufacturing
With two synthesis platforms under one roof—solid-phase synthesis for scales from μg to several kg and AJIPHASE™ for economical 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™, or a tailored combination of platforms with chemical or proprietary enzymatic ligation.
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. Then, we develop the downstream process using appropriate purification strategies such as IEX, RP-LC and UF/DF to achieve target purity and recovery.
Stability and Regulatory Support
In parallel, our teams develop and validate analytical methods in alignment with ICH Q2 expectations to support release, stability, and regulatory needs.
For scale-up and execution, we provide technology transfer documentation, including process descriptions, batch records, and risk assessments, to enable smooth progression across manufacturing stages.
Quality and Certification
Our quality systems support GMP operations through controlled batch record documentation, QA/QC oversight, and issuance of a Certificate of Analysis for every batch. We also support stability programs designed in accordance with ICH guidelines and can contribute to IND CMC data packages, including documentation and technical input.
200kg
AJIPHASE™ batch scale (confirm batch vs. cumulative)
8,000L
PMO reactor capacity
25+
Years of GMP oligo manufacturing experience
3
PMDA audits on record
Manufacturing Facilities
Three GMP-capable sites across Belgium and Japan, providing geographic and regulatory redundancy for global programs.
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
Solid-Phase oligo synthesis
Osaka, Japan
- 25+ years of oligonucleotide synthesis expertise
- PMDA audited
- Full solid-phase GMP 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
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?
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?
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 — confirm specific scope with QA before publication.
Do you support IND CMC filing for oligonucleotide drug substances?
Yes — process development, analytical characterization, and quality documentation to support IND CMC filings. Confirm exact scope of CMC support with our QA/RA team before finalizing your development plan.
What is the typical timeline for a GMP oligonucleotide manufacturing program?
Timeline depends on molecule complexity, modification type, required scale, and regulatory stage. Aji Bio-Pharma uses a milestone-based approach — confirm whether typical timeline ranges can be published with our operations team, as committing to specific durations without program context can be misleading.