Accelerating Method Development And Manufacturing Of GLP-1 Analogs With LC-UV/MS

By Duanduan Han, Samantha Ippoliti, Robert E. Birdsall, and Karen Nyholm, Waters Corporation

Glucagon-like peptide-1 (GLP-1) receptor agonists have recently emerged as powerful metabolic regulators in the treatment of type 2 diabetes and obesity, leading to an unprecedented surge in demand. In response, pharmaceutical manufacturers are reevaluating their production strategies to enhance efficiency and meet the growing needs of the market. To keep pace, there is a critical need for solutions that streamline information flow and accelerate decision-making—ensuring regulatory compliance, drug safety, and improved productivity. This application note introduces a quality control–friendly LC-UV/MS workflow designed to reduce the analytical burden on laboratories. By incorporating orthogonal mass data, supporting labs can make faster, more informed decisions during method development, minimizing errors and boosting overall efficiency.

At the heart of this solution is the integration of the ACQUITY™ QDa™ II Mass Detector with the Empower™ Chromatography Data System (CDS)—a scalable, compliance-ready software platform for instrument control, data acquisition, review, and reporting, complete with full audit trail capabilities. Paired with the Arc™ Premier System, this unique LC-UV/MS platform was validated through a real-world case study involving the rapid detection and putative identification of a process-related impurity in a GLP-1 analog.

Discover how this innovative workflow can transform your lab’s productivity and compliance.