Nanobodies

Nanobody & Single-Domain Antibody Characterization

Nanobodies (single-domain antibodies) have seen a rapid rise in interest and application in recent years. Their small size, high stability and excellent tissue penetration make them highly attractive for next-generation delivery systems, targeted therapeutics, imaging agents and multispecific formats. At the same time, their non-classical architecture and often high developability demands require dedicated nanobody characterization beyond standard antibody analytics.

At Biofidus, we offer a broad, state-of-the-art analytical platform for nanobodies and single-domain antibodies, covering both structural and functional characterization. Our portfolio includes in-depth analysis of protein primary structure, amino acid and post-translational modifications, charge and size heterogeneity, and purity and identity testing, supported by advanced LC-MS/MS, chromatographic and electrophoretic methods.

Functionally, we evaluate your lead nanobody candidates using customized cell-based assays and binding/kinetics studies by surface plasmon resonance (SPR) or related technologies, providing fit-for-purpose analytical packages for discovery, development, comparability and biosimilarity projects. Our extensive experience allows us to guide you through the available methods and define the optimal, ICH-aligned analytical strategy.

In accordance with your needs, we adapt and, where required, qualify our platform methods according to ICH guidelines, tailored to your drug substance (DS), its formulation matrix and your specific analytical questions.

Get in contact with us to quickly find the optimal setup for your analytical challenge and to speak directly from expert to expert.

Our Capabilities

  • Identity, primary structure and sequence integrity
  • Post-translational modifications
  • Charge variants and isoforms
  • Size variants, aggregation and fragments
  • Purity and product-/process-related impurities
  • Higher-order structure and conformational integrity
  • Target binding, affinity and kinetics
  • Biological potency
  • Stability assessement
  • Developability assessement

Just what you need? Contact us!

FAQ

Find answers to frequently asked questions about our analytical services, methods, technologies, and studies, from molecular characterization and bioactivity to comparability, stability, and fit-for-purpose method development. 

Yes. We tailor nanobody analytical packages to stage (discovery, development, comparability/biosimilarity) and matrix, adapting and qualifying methods where required.

Yes. We can include developability readouts such as stability under stress, aggregation propensity and higher-order structure assessments to identify risk early.

Yes. We assess charge and size heterogeneity using orthogonal methods (e.g., icIEF/CZE, SEC and CE-SDS) to support purity, stability and developability decisions.

Yes. We evaluate lead nanobody candidates using SPR binding/kinetics studies and customized cell-based assays to generate decision-ready functional data.

Because of their single-domain architecture and developability requirements, nanobodies often need dedicated characterization beyond standard IgG workflows, covering primary structure, PTMs, charge/size heterogeneity and functional binding/potency in formats appropriate to the molecule.

Standalone and integral bioanalytical services

TECHNOLOGIES USED

  1. LC-ESI-MS/MS peptide mapping
  2. LC-ESI-MS intact mass analysis
  3. Reversed phase (RP) chromatography
  4. Size exclusion chromatography (SEC)
  5. Hydrophilic interaction chromatography (HILIC)
  6. Hydrophobic interaction chromatography (HIC)
  7. Ion exchange chromatography (IEX)
  8. High performance anion exchange chromatography with pulsed amperometric detection (HPAEC-PAD)
  9. Absolute protein quantification (AQUA)
  10. Capillary gel electrophoresis (CGE)
  11. Capillary isoelectric focusing (cIEF)
  12. Capillary zone electrophoresis (CZE)-UV
  13. (2D-)SDS-PAGE
  14. Gel based isoelectric focusing (IEF)
  15. Western blot
  16. ELISA
  17. Surface plasmon resonance (SPR)
  18. Cell-based assays
  19. Plasma/serum stability assays
  20. Nanopore DNA/RNA sequencing
  21. qPCR
  22. Analytical ultracentrifugation (AUC)
  23. Circular dichroism (CD)
  24. Differential scanning calorimetry (DSC)
  25. Dynamic light scattering (DLS)
  26. Fourier transform infrared (FTIR) spectroscopy

Tell us about Your Project

We‘ll advise you to define your assay needs.

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Our Expert

Across end-to-end delivery, our experts remain on hand with deep scientific expertise whenever needed, providing oversight to streamline and de-risk milestone delivery.
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