Abstract
A combination of orthogonal biophysical techniques can provide an effective characterization of higher order structure supporting the development of biologic based drug products. Optical and vibrational spectroscopies play a central role in the product development biophysical arsenal. This chapter considers three spectroscopic techniques commonly employed in the biopharmaceutical development laboratory: ultraviolet (UV) absorption spectroscopy, fluorescence spectroscopy and Fourier Transform infrared spectroscopy (FT-IR). Each of these techniques is distinguished by practical nuances originating from their respective spectroscopic selection rules enabling applications as broad as rapid screening, analytical diagnostics, high concentration analysis and formal product characterization. The expanding field of biosimilars as well as rapid advancements in robotics and microfluidics are driving a renewed embrace of optical and vibrational spectroscopic methods for protein pharmaceutical development applications.
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