Peptide Biomanufacturing
Aji Bio-Pharma Services offers peptide biomanufacturing with CORYNEX™, our recombinant expression technology based on Corynebacterium glutamicum — suited to long-chain peptides and peptide fragments composed of natural amino acids at large commercial volumes. Strain, process, and analytical development are performed in-house in Kawasaki, Japan, and GMP manufacturing is carried out by qualified partner CDMOs under our technical oversight.
One Partner, Every Stage
We provide feasibility assessment and strain/process development in-house in Kawasaki, Japan. We see you through from lab-scale manufacturing to GMP manufacturing and drug substance delivery. The same dedicated Aji Bio-Pharma Services team oversees the program throughout.
4
Clinical Trials
15kL
GMP fermentation scale
11
Patents
When the Sequence Outgrows Chemical Synthesis
For long peptides of natural amino acids needed at very large volumes, recombinant expression with Corynex™ offers a route beyond chemical synthesis — with a single partner from development through commercial supply.
Secreted, Endotoxin-Free Expression
CORYNEX™ secretes the target peptide directly into the culture supernatant — no cell disruption or refolding — and gram-positive expression eliminates the endotoxin removal burden inherent to E. coli systems.
Hybrid Chemical / Fermentation Routes
For GLP-1 analogs and similar high-volume peptides, chemical and recombinant approaches can be combined to optimize yield, cost, and supply reliability within a single partner relationship.
IND CMC support
Process descriptions, analytical method summaries, and characterization data packages to support IND CMC filings — written to FDA and EMA expectations for long-chain peptide drug substances.
Non-Canonical Amino Acids
Peptides containing non-canonical amino acids are made by chemical synthesis with AJIPHASE™, including fragment-based strategies for long sequences.
Removing Barriers to Peptide Development
Focused on Analytical & Quality Development
Identity, purity, potency, and safety analytical methods developed and validated to ICH Q2 requirements. Core methods are performed in-house, with selected tests outsourced where necessary.
Let’s Discuss Your Peptide Biomanufacturing Program
Frequently Asked Questions
Does CORYNEX™ support cGMP manufacturing for clinical programs?
Yes. Strain, process and analytical development is done in-house at Kawasaki Japan, while GMP manufacturing is done by qualified CDMO partners globally under Aji’s technical oversight. CORYNEX™ has successfully supported 3 clinical trials (one in Phase II, two in Phase I)
What is the scalability of the CORYNEX™ platform?
Track record of scaling up to 15kL scale
Can CORYNEX™ produce the antibody component for an ADC program?
CORYNEX™ cannot produce full antibodies (neither as standalone nor for an ADC program). Full antibodies are typically made using CHO mammalian cells instead.
Are there any commercial drugs manufactured using CORYNEX™?
As of 2026, no approved commercial protein or peptide drugs have been manufactured using CORYNEX™. However, CORYNEX™ has a demonstrated clinical trial track record with programs advancing through development (currently up to Phase II). In addition, the host for CORYNEX™ (C. glutamicum) has been used to commercially manufacture various amino acids including those for pharmaceutical use for many decades and is one of the most well-characterized and heavily used microbials.
How does CORYNEX™ compare to AJIPHASE™ for peptide manufacturing?
Peptides are expressed in CORYNEX™ and synthesized in AJIPHASE™. Therefore, CORYNEX™ is suitable for large-scale sustainable manufacturing of peptide APIs and fragments without non-canonical amino acids, whereas AJIPHASE™ is applicable to peptide APIs and fragments with non-canonical amino acids.