Are you considering analyzing and characterizing your nanobodies ?
Why perform a nanobody analysis ?
Analyzing and characterizing nanobodies in the laboratory, which are antibodies derived from camels and llamas, is essential for evaluating their critical quality attributes (CQAs). These attributes include the primary structure, post-translational modifications, stability, and bioactivity of the nanobodies. Due to their unique small size, nanobodies exhibit distinct properties compared to traditional monoclonal antibodies, requiring specific methods for comprehensive evaluation. It is crucial to monitor these aspects rigorously throughout development and manufacturing, in compliance with guidelines such as ICH Q6B. Understanding variations that can affect critical quality attributes (CQAs), such as glycosylation profiles, charge variants, aggregates, or fragments, is vital for accurately assessing the heterogeneity and effectiveness of nanobodies.
Our solutions for nanobody analysis and characterization
Why choose FILAB ?
FILAB, a specialized analytical laboratory, provides in-depth expertise in analyzing and characterizing nanobodies while adhering to current guidelines, including ICH Q6B. With our expertise, we can design analyses tailored to your specific needs, regardless of the development stage, whether preclinical or in research and development.
FILAB laboratory offers customizable analytical services to meet your needs throughout the development and production cycle, with a particular focus on the critical quality attributes (CQAs) of nanobodies.
Nanobody characterization and analysis services
Structural analysis and characterization of nanobodies :
De novo sequencing
Glycosylation profiling
Physicochemical property characterization
We provide precise data on the size, mass, and physicochemical properties of nanobodies, which are essential for their development, validation, and quality control :
Molecular weight and size (intact mass by LC-MS and SEC-Triple detection)
Thermal stability (DSC)
Spectroscopic profiles (UV/visible absorption, FTIR)
Chromatographic profile (charge variants by IEX-UV)
Extinction coefficient (UV absorption)
Identification of impurities
Other services: analysis of various impurities (compliance with ich q3d, e&l, etc.)
For process-related impurities, we offer specific tests such as quantification of elemental impurities according to USP 233 and ICH Q3D, as well as analyses of extractables and leachables (E&L). We also analyze cell culture media (amino acids, vitamins, saccharides) to ensure the quality of bioproduction processes.
