Microfluidic Approaches for the Characterization of Therapeutic Proteins

Abstract

In the last decades, the pharmaceutical market has experienced an increase in the number of therapeutic proteins. The high activity and selectivity of these macromolecules is often achieved at the expense of complex structures, which exhibit several biophysical properties that must be carefully controlled and optimized for the successful development of these drugs as well as for guaranteeing their quality and safety. This need has motivated the application of a variety of biophysical techniques to analyze properties of therapeutic proteins and protein solutions including interactions, aggregation, solubility, viscosity, and thermal stability. After briefly summarizing currently available experimental approaches, we highlight the emerging possibilities offered by advances in microfluidic technology for the analysis of therapeutic proteins during manufacturing and formulation.

Keywords: analytical biochemistry; analytical chemistry; biopharmaceuticals characterization; biophysical models; formulation; microfluidics; monoclonal antibody; physical characterization; physicochemical properties; protein aggregation.