Development of biosimilars for marketed bio-therapeutics is expected to increase patient access and affordability of these therapeutics within the healthcare system. One of the key aspects of establishing biosimilarity at the analytical level is a comparative assessment of binding properties of the proposed biosimilar candidate and reference product. With a high level of sensitivity, and ability to measure kinetic parameters, Surface Plasmon Resonance (SPR) is an important analytical tool for characterizing binding properties of biological products. This presentation outlines strategies for biosimilar characterization utilizing various SPR methods. Challenges associated with day to day variability and statistical evaluation of data are summarized. Assay qualification efforts to make SPR assays more robust and repeatable, as well as solutions for better use of SPR as a part of biosimilar characterization are discussed.
Live Cell Imaging