Peptide Biomanufacturing
We offer 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.
Flexibility Across Development and Manufacturing
CORYNEX™ supports peptide programs from strain, process, and analytical development through technology transfer and GMP manufacturing. Development activities are performed in-house in Kawasaki, Japan, with GMP manufacturing carried out by a qualified partner CDMO under our technical oversight.
Phase II
Clinical Trial Experience
~15 kL
Achieved in GMP run
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, supporting programs 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.
Let’s Discuss Your Peptide
Biomanufacturing Program
Frequently Asked Questions
Does CORYNEX™ support GMP manufacturing for clinical programs?
Yes. CORYNEX™ strain, process, and analytical development is done in-house at Ajinomoto Bio-Pharma Services’ site in Kawasaki, Japan, while GMP manufacturing is done by qualified CMO partners globally under Aji Bio-Pharma’s technical oversight.
What is the scalability of the CORYNEX™ platform?
CORYNEX™ has demonstrated robust scalability, with successful scale-up to 15 kL fermentation scale. To support commercial supply, Ajinomoto Bio-Pharma Services leverages a network of manufacturing partners with fermentation capacities exceeding 100 kL, providing flexibility from development through large-scale production.