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
Confirm specific titer figures, case study details, and client permissions before publishing any example on the live site.
VHH Nanobodies
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
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Fewer Steps from Fermentation to Final Product
Every purification step removed is a yield improvement, a cost reduction, and a failure mode eliminated. CORYNEX™ protein manufacturing starts from a cleaner baseline than any E. coli route.
Fermentation
Corynebacterium glutamicum fermentation — protein secreted into culture medium in active form. No lysis, no inclusion body isolation.
Harvest & Primary Recovery
Cell removal by centrifugation or filtration. Clean starting material — no LPS, no inclusion body debris.
Chromatographic Purification
Capture, intermediate, and polishing steps. Fewer steps required vs. E. coli due to cleaner starting material and absence of LPS.
UF/DF & Formulation
Ultrafiltration/diafiltration for buffer exchange and concentration. Formulation development for stability.
Analytics & Release
Identity, purity, potency, endotoxin, and stability. CoA issued. Ready for non-clinical or clinical use.
GMP Supply
Clinical and commercial GMP batches manufactured at our partner CDMOs under Aji Bio-Pharma’s process oversight.
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 nanobody manufacturing?
Yes — VHH nanobodies are one of CORYNEX™’s primary applications. The key advantage is direct secretion: CORYNEX™ secretes VHHs into the culture medium in 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. The full VHH manufacturing service is detailed on the dedicated VHH Nanobody Manufacturing page.
Which GMP manufacturing sites support CORYNEX™ protein programs?
GMP manufacturing for CORYNEX™ programs is executed through two qualified partner CMOs: Richter Biológics and Olon S.p.A. Both 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 Aji Bio-Pharma support IND CMC filing for a recombinant protein program?
Yes. Aji Bio-Pharma 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.