Electrochemical methods for evaluation of therapeutic monoclonal antibodies: A review.

Biopharmaceuticals are complex pharmaceutical drug products produced by biotechnology in living systems. Small changes in the production process can induce differences in the structure of the active ingredient, which may have a strong impact on its pharmacological properties. Therefore, quality assurance of biopharmaceuticals results in a high analytical effort. Strict quality and stability monitoring of potentially critical quality attributes (CQAs) is required. Electrochemical methods have been contributing to the expansion of sensors and biosensors due to their advantages, such as cost-effectiveness and easy operation. Here, we discuss the recent developments in sensors and biosensors using electrochemical techniques employed for the determination of biopharmaceuticals, namely monoclonal antibodies (mAb) and fragments of mAbs. In the frame of this information, this review aims to critically address electrochemical sensors and biosensors for the analysis of biopharmaceuticals reported since 2016. Electrochemical bio(sensors) development has been mainly based on gold and aptamers, respectively, as the most used electrode material and biorecognition element. Also, Bevacizumab (BEVA) was the main therapeutic mAb detected and 69% of the works described a (bio)sensor) that can be applied to therapeutic drug monitoring.