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.