Analytical Strategies For High-Volume GLP-1 Manufacturing

This presentation focuses on the analytical strategies required to enable high-volume production, including the deployment of high-throughput chromatographic methods for impurity profiling, integration of orthogonal techniques such as LC-MS for identity confirmation, and the role of stability-indicating methods in maintaining product quality. It also examines bottlenecks in traditional quality control, particularly the impact of assay turnaround times and bioassay variability on batch release.