High-end Analytical Tools to Meet the Latest Regulatory Requirements for Generic Peptides

A Case Study TIDES USA 2024, Jean Marc Poudrel, Head of Regulatory Affairs at PolyPeptide SA
While regulatory requirements for generic peptides applications are becoming more and more demanding, the existing analytical tools and techniques are pushed to their limits to deliver the appropriate performance (resolution, sensitivity, precision). This presentation will go through a recent case study for a synthetic generic peptide of recombinant origin, where several high-end analytical techniques have been used to overcome the challenges of the most recent FDA guideline in this area.