Advancing Secondary Structure Characterization of Monoclonal Antibodies using Microfluidic Modulation Spectroscopy

Analytical Biochemistry | March 12, 2022

Valerie A. Ivancic (b), Holly L. Lombardo (b), EugeneMa (b), Mats Wikström (a), Dipanwita Batabyal (a)

(a)Amgen Inc., Higher Order Structure, Attribute Sciences, Thousand Oaks, CA, 91320, United States

(b) Redshift BioAnalytics, Inc., Burlington, MA, 01803, United States

Anal Biochem. 2022 Mar 12;114629.

DOI: 10.1016/j.ab.2022.114629


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.