Characterization of Three USP Reference Standards using Microfluidic Modulation Spectroscopy
February 1, 2023
In biologic drug production, monitoring critical quality attributes (CQAs) is paramount to achieving high-quality end products. These CQAs are physical attributes, which include primary sequence, molecular weight, charge, aggregation, and higher-order structure (HOS) variants.Equally important is the need for CQAs to pass specific criteria with clearly defined metrics using tools that are validated with known reference standards to deliver highly sensitive and quantitative data.
In this study we demonstrated the ability of MMS to measure the secondary structure of three different mAbs, in three different complex formulation buffers, and at a high and low concentration. Download the full app note to learn how the high reproducibility and ability to see small structural changes make MMS the ideal tool for characterization for quality assurance of monoclonal antibody therapeutics.