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FEB 20, 2017 8:00 AM PST

Characterization of Biosimilars by SPR

Speaker
  • Research Associate, Analytical Development department, Momenta Pharmaceuticals
    Biography
      Shashank is a Research associate in the Analytical Development department in Momenta Pharmaceuticals. He completed his Bachelors in Engineering from Bangalore, India in C.M.R.I.T. and earned his Master's in Biotechnology from Northeastern University, Boston, MA, USA. He has have worked on Surface Plasmon Resonance (SPR) methods to analyze binding affinity of various molecules in theĀ development pipeline in Momenta pharmaceuticals. His work focuses on developing, optimizing and qualifying SPR methods to obtain highly reproducible, high through-put and robust methods in support of functional characterization of these molecules.

    Abstract

    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.


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