AJIPHASE™ Scalable Manufacturing for Oligonucleotides and Peptides
AJIPHASE™ is our proprietary hybrid liquid-phase synthesis technology designed to produce high-purity, scalable peptides, oligonucleotides, and PMOs in a homogeneous reaction mixture. The platform supports programs from development to commercial GMP manufacturing with reduced environmental impact.
200 kg
Max AJIPHASE™ Synthesis Scale per Batch
8,000 L
Largest Reactor Used in GMP Manufacturing
2
GMP Sites Across Belgium and Japan
>90%
Organic Solvent Reduction vs. SPPS
Why AJIPHASE™ Changes the Scale Equation
AJIPHASE™ enables seamless scale-up from lab to commercial production across 1–8,000 L reactors, supported by commercial-scale manufacturing, 100 GMP production campaigns, and consistent product quality across scales. By lessening manufacturing waste, AJIPHASE™ supports pharmaceutical companies in achieving sustainability and ESG objectives while enabling efficient large-scale production.
How AJIPHASE™ Works
AJIPHASE™ combines key advantages of traditional solid-phase and liquid-phase synthesis by replacing the resin support with a proprietary soluble anchor. The anchor keeps reaction intermediates in solution in organic solvents, enabling homogeneous-phase synthesis in a single reactor, while also allowing intermediates to be isolated by precipitation or extraction as appropriate. This avoids the resin-packed column used in traditional solid-phase synthesis and the associated resin-based scale limitations, enabling GMP manufacturing at scales of up to 200 kg per batch using standard chemical reactors. AJIPHASE™ enables scalable, high-quality, and more environmentally sustainable manufacturing of oligonucleotides, peptides, and PMOs.
AJIPHASE™ Applications by Molecule Type
Oligonucleotides, PMOs, and peptides — proven capabilities across a range of molecule types and production scales. AJIPHASE™ is validated across each of these programs. Not every molecule fits every platform — here’s how AJIPHASE™ performs by modality.
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 is 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.
Peptides
AJIPHASE™ provides a scalable manufacturing platform for peptides, particularly high-volume therapeutics such as GLP-1 analogs and complex structures such as multi-cyclic peptides. The liquid-phase process enables efficient large-scale production with reduced amino acid, reagent, and solvent consumption while utilizing standard chemical manufacturing equipment. Both GMP and non-GMP manufacturing are available, supported by extensive manufacturing experience and integrated CMC expertise from development through commercial supply.
A More Sustainable Path to Scale and Reliability
As oligonucleotide and peptide therapies advance toward larger patient populations, manufacturing processes must deliver not only scalability and reliability, but also improved sustainability. AJIPHASE™ addresses these challenges through highly efficient liquid-phase chemistry that enables large-scale production while reducing resource consumption.
Compared with traditional solid-phase synthesis, AJIPHASE™ reduces the consumption of solvents, reagents, and raw materials, helping to lower process mass intensity. These efficiencies can reduce environmental impact while also improving manufacturing economics, making sustainability and cost efficiency complementary, rather than competing objectives.
From Research to Commercial: One Platform Throughout
AJIPHASE™ supports oligonucleotide and peptide programs from development through commercial supply on a single scalable platform. For programs developed using conventional synthesis methods, Ajinomoto Bio-Pharma Services can help evaluate and implement a transition to AJIPHASE™ while minimizing development risk. Backed by integrated process development, analytical, regulatory, and manufacturing expertise, we help customers realize the benefits of scalable, efficient, and cost-effective manufacturing throughout the product lifecycle.
Let’s Discuss AJIPHASE™ for Your Program
Whether starting a new program or transitioning from an existing synthesis process,
AJIPHASE™ provides a practical path to scalable manufacturing.
Frequently Asked Questions
What is AJIPHASE™ and how does it differ from solid-phase 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 AJIPHASE™ synthesis under cGMP?
AJIPHASE™ synthesis is highly scalable — up to 200 kg per batch for oligonucleotides and exceeding 100 kg per batch for peptides — in one reactor with no additional specialized equipment, providing cost-effective and pure oligonucleotides and peptides with fewer waste byproducts. AJIPHASE™ allows for optimized time, cost, and value when scaling your products to commercial quantities.
Does AJIPHASE™ produce equivalent purity to traditional solid-phase synthesis?
AJIPHASE™ supports the transition from traditional solid-phase synthesis through tailored process and analytical development to establish comparable purity and impurity profiles. CMC support for the manufacturing change can also include comparability assessments, impurity evaluation, analytical bridging, and supporting documentation for regulatory submissions
Does AJIPHASE™ offer cost advantages over traditional solid-phase synthesis at large scale?
Because AJIPHASE™ requires less solvent and reagents than solid-phase synthesis for large-scale production, it provides increased sustainability and cost-effective manufacturing advantages.