Investigations into the Impact of Excipients and their Purity on Drug Delivery by Mass Spectrometry

The aim of this project is to support one of our strategic aims in developing a better understanding of the role which excipients play in drug delivery and bioavailability. One critical aspect lies in how these materials interact with proteins, particularly those involved in drug transport across cell membranes. This project would help develop our understanding of how excipients interact with biological active pharmaceutical ingredients (from simple peptides, to proteins and mAbs) in formulations developed by the biopharmaceutical industry, which is also targeted as key growth sector for the industrial partner Croda HC.
Native Mass Spectrometry (MS) is well recognized throughout both industry and academia as an essential tool in biomolecular characterization, giving unique insights into protein and peptide composition, structure and conformation, particularly when used in conjunction with advanced separation techniques such as Ion Mobility and chemical labelling methodologies including Hydrogen Deuterium Exchange (HDX) and Fast Photochemical Oxidation of Proteins (FPOP) (see Figure).
Through evaluating both structure (and purity) and property relationships in this key aspect of drug bioavailability, this study would also help us generate future claims data on the value of efficacy of differentiated highly purified excipients, as well as guiding future development of new variants and identify new chemistries of potential value