VHH ANTIBODY CDMO

GMP VHH Antibody
Manufacturing Platform

We’ve developed a microbial platform for GMP-grade VHH antibody production also referred to as nanobodies®. Optimized for E. coli and P. pastoris (K. phaffii), our platform enables fast, high-quality delivery of custom single-domain antibodies in monomer or multimer formats, from research cell bank to GMP batch in just 8 months.

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VHH production toolbox
built on diverse models

We’ve developed a robust VHH production toolbox in E. coli and P. pastoris, tested on a broad range of antibody formats including
mono, bi, and tri specific formats, with isoelectric points from pI 5 to 9 and varied hydrophobicity profiles. This platform integrates
various host systems, fermentation strategies, purification, and QC methods to rapidly fine-tune each production process
and deliver GMP single domain antibodies adapted to your needs.

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Two expression platforms

  • P. pastoris (K. phaffii)
  • E. coli

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Fermentation

  • High-cell density fed-batch
  • Control of critical fermentation parameters
  • Animal-free media

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Purification types

  • Ion-Exchange
  • Hydrophobic Interaction Chromatography (HIC)
  • Mix mode
  • Affinity

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Quality Control

  • GMP QC package
  • Additional custom QC development available
  • QP release

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Fast track your GMP VHH project

Starting from your research cell bank, we rapidly define the most suitable fermentation and purification process for your VHH antibody.
Our microbial expression platform and CDMO services support GMP-grade VHH production for preclinical studies, clinical trials, and commercial supply.
With scalable production and GMP compliant operations, we accelerate your VHH-based molecule to market and offer the option to
validate your process for long-term commercial success.

Start your VHH production

 

 

GMP QC Package

Our GMP QC package includes a full panel of analytical methods for GMP-grade VHH release.
Optional tests can be added based on your molecule’s specific needs.

 

Attributes Testing
Identity SDS PAGE
Western Blotting
SE-HPLC
Purity Molecular size distribution by SE-HPLC
Appearance Colorimetry
Turbidimetry
Physico-chemical pH
Protein content UV / µBCA / Lowry
Impurity Host Cell Protein by ELISA 
Host Cell DNA by qPCR
Safety Endotoxin
Bioburden
Residual Methanol / IPTG
Protein A (ELISA)

 

 

Optional QCs

Attributes Testing
Identity ESI-Q-TOF
RP-HPLC
Purity RP-HPLC
Physico-chemical Visible particles
Osmolarity
Potency Antigen binding assay by SPR
ELISA

 

 

High quality single-domain antibodies

High Purity Level

SE-HPLC analysis of a trivalent bispecific VHH shows a purity level of 98.7%.

Binding Affinity

SPR analysis (Biacore system) confirms that Eurogentec’s bulk material displays binding affinity equivalent to the commercial reference, with Kd values of 19.7 nM and 20.9 nM, respectively.

Full Service CDMO

From scale-up to commercial supply, we support your project every step of the way.

Large scale manufacturing options

We offer scalable microbial production to support later-stage clinical trials and commercial supply.

PPQ and Commercial Experience

Since 1994 our team has acquired extensive experience managing PPQ campaigns and supply for commercial use.

Helping you navigate late phase manufacturing

With our flexible approach, we act as a long-term partner committed to your success

Explore our related services

From RUO-grade VHH antibodies to GMP antibody fragments, recombinant proteins, and conjugates, we provide a broad range of CDMO services to support your therapeutic programs. Our solutions help you advance from early discovery to clinical and commercial manufacturing with confidence.