AJIPHASE™ for Oligonucleotides
AJIPHASE™ provides a scalable manufacturing platform for ASOs, siRNAs, PMOs, and oligonucleotide conjugates, using the same phosphoramidite chemistry as conventional solid-phase synthesis. By performing synthesis in solution rather than on a solid support, AJIPHASE™ enables highly efficient reactions and cGMP manufacturing of up to 200 kg per batch in standard chemical reactors.
The AJIPHASE™ Process: Step by Step
AJIPHASE™ utilizes the same phosphoramidite chemistry as conventional solid-phase oligonucleotide synthesis, enabling impurity profiles comparable to those of established solid-phase processes. By maintaining the same fundamental chemistry, AJIPHASE™ supports analytical comparability and familiar quality assessment strategies while providing the scalability advantages of liquid-phase manufacturing
AJIPHASE™ Applications by Molecule Type
ASOs, siRNAs, PMOs, and oligonucleotide conjugates — proven capabilities across molecule types and production scales.
Oligonucleotides
AJIPHASE™ provides a scalable manufacturing platform for ASOs and siRNAs using the same phosphoramidite chemistry as conventional solid-phase synthesis. Common modifications such as 2′-modifications and phosphorothioate (PS) backbones and conjugations are supported. For siRNA, AJIPHASE™-manufactured or solid-phase-manufactured fragments can be combined with enzymatic ligation, providing a cost-effective route to higher product quality and enhanced scalability. GMP manufacturing are available, supported by extensive manufacturing experience and CMC support expertise.
PMO
AJIPHASE™ provides a highly scalable manufacturing platform for PMOs, particularly for programs requiring quantities above 100 g through commercial supply. The platform enables seamless scale-up, robust process control, and cost-efficient manufacturing using standard chemical reactors. Both GMP and non-GMP manufacturing are supported by extensive manufacturing experience and integrated CMC expertise from development through commercial supply.
One Platform, Every Stage
Whether starting with AJIPHASE™ or transitioning from conventional synthesis methods, customers can leverage a single scalable platform from development through commercial supply. This continuity helps reduce technology transfer requirements, minimize development risk, and support scale-up
Process Development
Operating under non-GMP conditions at scales ranging from grams to 100 grams, the Process Development phase establishes the technical foundation for your liquid-phase oligonucleotide synthesis (LPOS). This stage focuses on reaction optimization, yield enhancement, and robust analytical method development, laying the groundwork for a scalable, efficient, and reproducible chemical process prior to regulatory translation.
Clinical Manufacturing
Transitioning into full cGMP compliance, Clinical Manufacturing scales production from 200 grams to kilogram quantities to support clinical evaluation. Key deliverables include comprehensive batch production documentation, verified Certificates of Analysis (CoA), and ICH-compliant stability programs—ensuring complete regulatory alignment and product quality for human administration.
Commercial Supply
Designed for long-term campaign readiness and repeat batch production, Clinical Supply delivers reliable, commercial-ready cGMP manufacturing. By executing a fully defined, repeatable process with the exact same dedicated technical team, this phase guarantees campaign-to-campaign consistency, risk mitigation, and seamless supply chain continuity across trial phases.
Where AJIPHASE™ Is Made
Two cGMP facilities — Tokai, Japan and Wetteren, Belgium — offer geographic and regulatory redundancy for global programs requiring AJIPHASE™ capacity.
AJIPHASE PRODUCTION
Tokai, Japan
Japan serves as the center for AJIPHASE™ process development, analytical development, technology transfer, and cGMP manufacturing. Integrated development, quality, and manufacturing teams support programs from early development through commercial supply.
Flow Chemistry
Wettern, Belgium
Belgium provides cGMP peptide manufacturing capabilities using AJIPHASE™, conventional liquid-phase synthesis, and flow chemistry technologies. The site supports commercial production, scale-up, and long-term supply of peptide therapeutics.
Let’s discuss AJIPHASE™ for your program
Same process. Same team. Every scale.
Frequently Asked Questions
What makes AJIPHASE™ different from traditional solid-phase synthesis?
AJIPHASE™ is a liquid-phase synthesis platform that uses a soluble anchor rather than a solid support. By performing synthesis in solution, AJIPHASE™ enables efficient reactions while reducing the consumption of monomers, reagents, and solvents. This supports scalable, cost-effective, and sustainable manufacturing using standard chemical reactors while maintaining consistent and reliable quality.
What scale can AJIPHASE™ reach under cGMP?
AJIPHASE™ can demonstrate cGMP manufacturing of oligonucleotides at scales of up to 200 kg per batch. The platform also supports large-scale oligonucleotide and peptide manufacturing in reactors up to 8,000 L. AJIPHASE™ enables seamless progression from development through commercial supply
Is the AJIPHASE™ process the same at every development stage?
Yes. AJIPHASE™ uses the same fundamental chemistry and single-reactor process from research through commercial scale, minimizing technology-transfer risk as programs scale.
Where is AJIPHASE™ manufacturing performed?
AJIPHASE™ is supported by manufacturing in Japan and Belgium, providing global cGMP supply capabilities.
What oligonucleotide types can be made using AJIPHASE™?
AJIPHASE™ can be used in the development and manufacturing of ASOs, siRNAs, Phosphorodiamidate Morpholino Oligonucleotides (PMOs), and oligonucleotide conjugates, as well as chemical/synthetic peptides.