GLP‑1 Analogs: Enhancing Impurity Profiling with LC‑UV/MS Workflows

Analytical Strategies for GLP-1 Therapeutics: Advancing Impurity Profiling with LC-UV/MS and High Resolution MS 

Glucagon-like peptide-1 (GLP-1) receptor agonists have transformed the treatment of type 2 diabetes and obesity, while increasing molecular complexity has created new analytical challenges for pharmaceutical scientists. Sequence modifications, fatty acid conjugation, and emerging multi-agonist designs require robust analytical strategies capable of detecting, characterizing, and monitoring impurities throughout development and manufacturing to ensure product quality, safety, and efficacy.

Why you should attend

This webinar will showcase complementary LC-MS approaches for the characterization and impurity profiling of GLP-1 therapeutics.

Part 1 will highlight the use of LC-UV/MS workflows as a versatile toolbox for impurity analysis of exenatide. Case studies will demonstrate how orthogonal mass information can enhance impurity detection beyond UV-based analysis, while complementary chromatographic approaches, including reverse-phase liquid chromatography (RPLC) and hydrophilic interaction liquid chromatography (HILIC), improve impurity resolution and raw material screening. Applications for characterizing amino acid sequence variants, monitoring stability-indicating impurities, and supporting risk-based decision-making in peptide manufacturing environments will be discussed.

Part 2 will focus on advanced characterization of the tirzepatide using high resolution mass spectrometry (HRMS). Through forced degradation studies under oxidative stress conditions, HRMS will be used to confidently identify degradants and elucidate impurity pathways, providing detailed structural insights into sites of molecular vulnerability and degradation mechanisms. Case studies will demonstrate how HRMS supports comprehensive characterization of complex peptide therapeutics and helps establish the analytical methodologies needed to identify and control clinically relevant impurities.

Key Learning Objectives

• Apply LC-UV/MS workflows to characterize impurities, sequence variants, and stability-indicating degradants in GLP-1 therapeutics.
• Leverage complementary RPLC and HILIC separations to improve impurity detection and analytical confidence.
• Understand how HRMS enables detailed structural characterization of GLP-1 analogs and their impurities.U
  se forced degradation studies and degradant identification to support stability assessment and impurity control strategies.

Who should attend

This webinar is designed for analytical development, LC-MS, CMC, and QC scientists working in pharmaceutical and biotechnology organizations developing or manufacturing GLP-1 and other therapeutic peptides.

Don't miss it!

Presenter: Duanduan Han, Ph.D. (Senior Scientist, Waters Corporation)

Duanduan Han is a Senior Scientist at Waters Corporation in Milford, MA. She specializes in LC–MS method development and troubleshooting, impurity profiling, and raw material screening for biopharmaceutical products and new modalities, including GLP‑1 therapeutics, lipid nanoparticles, oligonucleotides, surfactants, and monoclonal antibodies.

She earned her PhD in Chemical Engineering from Texas A&M University.

Presenter: Christopher Henry (Senior Scientist, Waters Corporation)

Chris Henry is a Principal Scientist at Waters Corporation in Wilmslow, UK. He has worked at Waters for 13 years focusing on LC-MS and GC-MS method development across small molecule and large molecule workflows using high resolution mass spectrometry.