The U.S. Pharmacopeia (USP) has launched a new set of solutions to support product quality for manufacturers of glucagon-like peptide-1 (GLP-1) receptor agonists.

GLP-1 agonists are complex products that require quality-assurance testing for both product- and process-related impurities to protect patients. Identifying and controlling these impurities can be challenging and time-consuming.

New resources from USP include well-characterized Analytical Reference Materials (ARMs) and corresponding information sheets to enable confidence in the accuracy of analytical results.

“GLP-1 receptor agonists face unprecedented demand from patients due to their transformative value for treating conditions like diabetes and weight management,” said Fouad Atouf, PhD, Chief Science Officer of USP. “These USP solutions can help ensure analytical accuracy of test methods and, ultimately, help ensure product purity.”

“These new resources complement best practices outlined in two general chapters in USP-NF—<1503> Quality Attributes of Peptide Drug Substances and <1504> Quality Attributes of Peptide Starting Materials and provide a scientific foundation that supports consistent quality assessment and regulatory confidence in these complex products,” said Diane McCarthy, Vice President for Global Biologics.

USP worked with industry and regulatory stakeholders to understand the inherent complexity of these products and associated quality challenges. These resources will support process development and validation activities for generic versions.

USP will continue to engage and work with industry and regulatory stakeholders to identify priority challenges and deliver solutions that support product quality and regulatory clarity.