AN1901: Identification of GLP-1 analog oligomeric states using SEC-MALS

Glucagon-like peptide-1 analogs (GLP-1a), like liraglutide and semaglutide, are among the highest-growing therapies with seven FDA-approved treatments and more than 50 in clinical trials as of 2024. A key challenge during their development, formulation, and manufacturing is the formation of complex structures that can span from oligomers to aggregates and fibrils. To ensure the safety and efficacy of GLP-1a based therapeutics, it is critical to characterize these complex structures to formulate the product properly to avoid the undesirable high order structures. This application note demonstrates the use of size-exclusion chromatography coupled with multi-angle light scattering (SEC-MALS) under both native and denaturing conditions to identify, quantify, and characterize the monomer, oligomeric state and aggregates present in the commercial GLP-1a products and biosimilars.