Advancing secondary structure characterization of monoclonal antibodies using Microfluidic Modulation Spectroscopy.

ABSTRACT

Infrared (IR) spectroscopy is rapidly gaining traction for monitoring biotherapeutic critical quality attributes. Microfluidic Modulation Spectroscopy (MMS), a novel automated IR technology, has been shown to be an effective technique for generating high quality, reproducible secondary structure data for protein therapeutics including monoclonal antibodies. In this study, monoclonal antibodies (mAbs) at concentrations ranging from 0.5 to 50 mg/mL were analyzed and high-quality data was obtained by optimizing two critical acquisition parameters (a) sample modulation frequency and (b) detector dwell time settings. The ability to generate reproducible data with high sensitivity at low formulation concentrations indicates that MMS is a reliable method for evaluating the secondary structure of low concentration biotherapeutic formulations and modalities.