Orthogonal Similarity Assessment of Monoclonal Antibodies Using CD, FTIR, and Raman

The biopharmaceutical market has been expanding dramatically over the past decade, particularly for therapeutic antibodies. As innovative antibodies are developed there is a strong push to develop biosimilars with identical higher order structure (HOS). The HOS of biopharmaceuticals directly impacts their efficacy and safety, which means verifying HOS is of great importance.

Current FDA guidelines emphasize the use of orthogonal quantitative methods in thecomparison of reference products with biosimilars. For proteins, such as antibodies, circular dichroism, Fourier transform Infrared, and Raman spectroscopy are excellent tools for structural determination. To quantitate spectral difference for these spectroscopic techniques, Jasco has developed qHOS, a powerful spectral assessment tool. In this webinar we outline thestudy of monoclonal antibody structure using qHOS and various spectroscopic techniques.