XeriSol: A non-aqueous peptide formulation approach for enhanced stability and solubility
Michael Neely
Consultant, Xeris Pharmaceuticals Inc.
Peptide drug formulations are prone to degradation and aggregation/fibrillation in aqueous environments. Our proprietary, commercially-validated XeriSol™ non-aqueous formulation technology platform is designed to address the limitations of aqueous formulations for peptide drugs. The solutions are formulated using FDA-approved biocompatible, non-aqueous solvents that have higher stability and solubility. The solvent prevents degradation and aggregation/fibrillation of the peptide and allows for development of room-temperature stable, ready-to-use, small-volume peptide formulations. We have formulated numerous peptides of commercial interest with the XeriSol technology including glucagon (FDA approved as Gvoke®, EMA approved as Ogluo®), insulin, pramlintide, icatibant, thyroid hormone, vasopressin, etc. In each case, the XeriSol platform allows us to achieve a higher concentration/solubility and stability. Further, certain aspects of the technology allow for creating a sustained release profile for certain peptides. This presentation will focus on opportunities created by the XeriSol platform to reduce risk and speed development for peptide therapeutics.
Michael Neely is retired from a 42 year career in the Pharmaceutical and Biopharm Industry. He was instrumental in founding Mallinckrodt's Peptide CMO API manufacturing initiative in 1991 and has served in numnerous other manufacturing, marketing and Business Development roles. Neely holds a BSc in Chemistry from Washington University and MBA from the Olin School at Washington University. He currently consults in the Biopharmaceuticals industry and is under contract with Xeris Pharmaceuticals, Inc.