Seminar: "Development of an electrochemical tool-kit for improved bioprocessing applications"

Abstract: Recombinant monoclonal antibodies (mAbs) have become an important class of biopharmaceuticals that have shown effectiveness in treating a variety of diseases such as cancer, infection, and inflammation. Importantly, process conditions established during the development and manufacture of mAbs dramatically impacts their quality and clinical efficacy. Technologies that enable rapid and cost-effective assessment of product quality are critically important as they trim development time and costs. Here, we demonstrate the development of electrochemical-based analytical technologies that will enable low volume, near real-time monitoring of mAb product quality attributes and process parameters. First, we demonstrate the development of sensor interfaces for the detection of antibody titer and N-linked glycosylation. The interfaces couple a spatially resolved electroassembled thiolated polyethylene glycol hydrogel with molecular recognition-based elements to provide rapid and robust assessment. Next, we report a rapid electronic approach, mediated electrochemical probing (MEP), to detect redox-based structural perturbations. Specifically, we studied NISTmAb variants that have undergone interchain-disulfide bond reduction and methionine oxidation. We also demonstrate successful integration of both methodologies with microfluidic devices to enable rapid, low volume sampling that is amenable to on-line monitoring. We believe that these technologies can provide fast, quantifiable results for bioprocessing applications and offer advantages in their simplicity, rapid response, and connectivity to electronics.