Biotherapeutic products such as monoclonal antibodies and biosimilars are structurally complex, and no single analytical technique can provide a complete understanding of their higher-order structure, similarity, stability, and degradation. This webinar will demonstrate how orthogonal analytical assessment, using multiple complementary techniques based on different measurement principles, can provide greater confidence in biotherapeutic characterization and product quality.
The presentation will introduce the regulatory rationale for comprehensive biotherapeutic characterization and highlight JASCO’s analytical toolkit, including circular dichroism (CD), fluorescence, UV-Vis, FTIR, Raman spectroscopy, HPLC, and qHOS higher-order structure similarity evaluation software. qHOS enables objective statistical comparison of complete spectral datasets using approaches such as noise weighting, t-tests, TOST analysis, and concentration correction rather than relying solely on visual spectral comparison.
Through practical case studies, the webinar will demonstrate secondary- and tertiary-structure characterization, innovator–biosimilar similarity assessment, thermal stability analysis, and forced-degradation studies. Examples include orthogonal CD/FTIR characterization of IgG, four-way comparison of MabThera® and RIABNI™ using CD, FTIR, Raman and qHOS, thermal denaturation studies of antibodies, and sensitive detection of structural changes caused by photo-oxidation and reduction.
The webinar will ultimately show how complementary analytical methods can support biotherapeutic development from early discovery and lead optimization through formulation, stability testing, comparability, and quality control, providing stronger evidence for product structure, stability, similarity, purity, and overall quality.
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