Ensuring the safety and efficacy of biologics products

In this article, Dr Shishir Chundawat and Aron Gyorgypal from Rutgers University, US, explain how they developed a new process analytical technology (PAT) system for the automated monitoring of antibody N-glycosylation.

The ability to rapidly monitor and characterise biological drug molecules like glycosylated monoclonal antibodies (mAbs) using advanced analytical techniques throughout the manufacturing process workflow is vital to meet regulatory requirements. Access to such automated tools can also be useful during other stages of a biologic drug’s lifecycle; both during the early stages of candidate drug discovery and clinical trials as well as during the later stages of larger scale biologics manufacturing.