Nanobody & VHH Manufacturing
Our nanobody and VHH development and manufacturing services support programs from early strain development and expression screening through process development and GMP production, using CORYNEX™ microbial expression technology to enable efficient production of active, properly folded proteins.
VHH Strain Development
Strain engineering for the specific VHH sequence. Expression and secretion confirmation. Initial titer and purity data. Non-GMP. Aji Bio-Pharma fee-for-service.
Process Development
USP and DSP optimization. Analytical method development. Scale-up strategy aligned with target GMP facility.
GMP Manufacturing
Tech transfer to our partner CMOs. GMP batch manufacturing. Release testing. Stability. CoA. Clinical or commercial supply.
Powerful Microbial Platform That Secretes VHHs in Active, Properly Folded Form
Disulfide bond integrity
Target proteins are secreted directly to the media in correctly folded form with proper disulfide bonds and activity.
No refolding required
Refolding can be eliminated since the target proteins are not accumulated intracellularly as inclusion bodies but rather secreted directly into the media in correct form
Endotoxin-free
CORYNEX™ is endotoxin-free because it is based on the gram-positive bacteria C. glutamicum, which eliminates the need for endotoxin removal.
Simplified purification
High purity, endotoxin-free expression result in simplified purification.
Higher yields
10+ g/L yields in combination with shorter fermentation times lead to extremely high productivity
Fewer Steps from Fermentation to Final Product
By eliminating the need for protein refolding and endotoxin (LPS) removal, protein secretion enables a streamlined workflow that moves directly from fermentation to chromatography. This simplified, highly scalable process maximizes purity and overall recovery through fewer purification steps, significantly driving down manufacturing costs per gram while accelerating timelines to the final drug substance.
Let’s discuss VHH nanobody
manufacturing for your program
Endotoxin-free. Properly folded. No refolding required. From feasibility to GMP.
Frequently Asked Questions
What is CORYNEX™ and how does it differ from E. coli expression systems?
C. glutamicum is gram-positive: no LPS → endotoxin-free output → simplified purification. Proteins secreted into culture medium in active, properly folded form — no inclusion body refolding required.
What types of proteins and antibody fragments can CORYNEX™ produce?
CORYNEX™ can produce VHH/nanobodies, long peptides, antibody mimetics, and various other non-glycosylated proteins. It has been used to successfully make over 1000 targets to date.
Does CORYNEX™ support GMP 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 Bio-Pharma’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). Shall instead be typically made using CHO mammalian cells.
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.