Protein Manufacturing
Our protein development and manufacturing services support recombinant protein programs from early expression and process development through technology transfer and commercial GMP production, combining specialized fermentation, purification, and analytical expertise.
Production Examples by Molecule Class
VHH Antibodies
Secreted in active, properly folded form — no refolding required. High titer via CORYNEX™. Applicable to therapeutic VHHs, diagnostic VHHs, VHH-drug conjugates, and multi-specific formats.
PAS Fusion Proteins
Half-life-extended proteins using PAS sequences. CORYNEX™ as the secretory expression platform; XL-protein as the PASylation® technology partner. Applicable to VHHs, peptides, and other rapidly cleared therapeutic proteins as a biological alternative to PEGylation.
Long-Chain Peptides
Scalable and sustainable manufacturing of long-chain peptides and peptide fragments composed of natural amino acids, delivering high titers, purity, and overall productivity. Applicable to GLP-1-related and other long-acting peptides and peptide fragments for downstream conjugation.
Fewer Steps from Fermentation to Final Product
CORYNEX™ starts with cleaner fermentation output than conventional E. coli-based expression, helping reduce downstream processing requirements by eliminating cell lysis, inclusion body isolation, refolding, and LPS removal.
Fermentation & Harvest
Corynebacterium glutamicum fermentation secretes the target protein into the culture medium in active form. Following fermentation, cells are removed by centrifugation or filtration, providing cleaner starting material without cell lysis, inclusion body isolation, or LPS.
Purification
Capture, intermediate, and polishing steps are streamlined by cleaner starting material and the absence of LPS, reducing purification requirements compared with E. coli-based expression.
Formulation & Release
Ultrafiltration/diafiltration supports buffer exchange and concentration, followed by formulation development for stability. Analytical testing supports identity, purity, potency, endotoxin, and stability, with CoA issuance for release.
GMP Supply
Clinical and commercial GMP batches are manufactured by a qualified manufacturing partner under our experts’ technical oversight.
CORYNEX™ vs. Competitive Expression Systems
CORYNEX™ combines the advantages of traditional E. coli, CHO, and Yeast platforms. It secretes targets directly into the media with high titers and purity, without endotoxins, cell lysis, protein refolding, or complex purification steps. It is fast-growing and scalable, leading to higher overall productivity.
Explore a Better Expression Platform for Protein Manufacturing
Frequently Asked Questions
Does CORYNEX™ require protein refolding?
No. CORYNEX™ secretes target proteins directly into the culture medium in properly folded, biologically active form. This is one of its core advantages over E. coli inclusion body expression, which requires cell lysis, inclusion body isolation, chemical denaturation, and a refolding process that is difficult to scale, prone to inconsistency, and frequently results in yield losses. Eliminating refolding removes the most failure-prone step in E. coli protein manufacturing and significantly simplifies the downstream process.
Is CORYNEX™ a good platform for VHH manufacturing?
Yes — VHH antibodies are one of CORYNEX™’s primary applications. The key advantage is direct secretion: CORYNEX™ secretes VHHs into the culture medium in a properly folded, biologically active form, eliminating the inclusion body refolding that frequently causes yield loss and inconsistency in E. coli VHH expression. The endotoxin-free baseline further simplifies downstream processing for therapeutic VHH programs.
Which GMP manufacturing sites support CORYNEX™ protein programs?
GMP manufacturing for CORYNEX™ programs is executed through Ajinomoto Bio-Pharma Services’ qualified partner CMOs, including Richter Biológics and Olon S.p.A. These sites are pre-qualified for CORYNEX™ processes and operate under Aji Bio-Pharma’s technical oversight and quality framework. EU-based manufacturing at both sites supports programs requiring EMA-compliant supply chains. Programs requiring US FDA-compliant manufacturing should confirm specific site qualification status with the Aji Bio-Pharma team.
Can Ajinomoto Bio-Pharma Services support IND CMC filing for a recombinant protein program?
Yes. Ajinomoto Bio-Pharma Services provides process development data and documentation to support IND CMC filings for CORYNEX™ protein programs. This includes process descriptions, analytical method summaries, and characterization data packages aligned with FDA and EMA CMC expectations for recombinant proteins. The exact scope of CMC documentation support is confirmed with the Aji Bio-Pharma QA/RA team at the start of each program.
What are the advantages of C. glutamicum over E. coli for protein manufacturing?
Compared to E. coli for recombinant protein manufacturing, C. glutamicum (the host used in CORYNEX™) offers three primary advantages: it produces no lipopolysaccharide (endotoxin), eliminating LPS removal steps from downstream processing; it secretes proteins directly into the culture medium in properly folded form, eliminating inclusion body refolding; and it has a 60+ year industrial fermentation safety record as a non-pathogenic organism.
Can Ajinomoto Bio-Pharma Services introduce non-natural amino acids? What non-natural amino acids are applicable for CORYNEX™?
Yes. CORYNEX™ supports the efficient incorporation of several non-canonical amino acids, including p-azido-L-phenylalanine (AzF), for applications such as site-specific conjugation. Contact the Ajinomoto Bio-Pharma Services technical team to discuss currently available ncAAs and options for your target protein.