Visit us at Booth 16!
Protein higher-order structure (HOS) and dynamics are essential to protein function. For protein-based therapeutic products, HOS is a critical quality attribute which needs to be monitored to ensure safety and efficacy of drug products. HOS can be monitored by a multitude of biophysical and structural characterization tools such as Aurora, featuring Microfluidic Modulation Spectroscopy. The choice of the appropriate biophysical method and the method development and qualification strategies to characterize and control HOS at different stages of the product lifecycle are a matter of interest and debate for a wide range of audiences.
RedShiftBio Poster Presentation:
Wednesday, September 6, 2023
Session 1: 1:00pm - 1:55pm CDT
Structural Characterization and Comparison of Temperature and Pressure Stress on a Protein Library Across pH and Concentration Using Microfluidic Modulation Spectroscopy
Presenter: David Sloan, PhD
Day 1 Customer Presentation:
Advancing Secondary Structure Characterization of Monoclonal Antibodies Using Microfluidic Modulation Spectroscopy
Dipa Batabyal, PhD - Amgen, Inc
Session I: HOS Technologies 09:00 - 10:25 Wednesday, 6th September, 2023
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.