Research project
Protein stability in drug delivery systems
Therapeutic protein drugs are invaluable to human healthcare, providing unique treatments to numerous diseases and disorders. There are already dozens of protein products on the market and hundreds more in preclinical and clinical development. Therewith, protein stability has gained enormous attention as a major product quality issue as well as a potential safety concern. It must be realized that proteins are only marginally stable and are highly susceptible to both chemical and physical degradation.
Therapeutic protein drugs are invaluable to human healthcare, providing unique treatments to numerous diseases and disorders. There are already dozens of protein products on the market and hundreds more in preclinical and clinical development. Therewith, protein stability has gained enormous attention as a major product quality issue as well as a potential safety concern. It must be realized that proteins are only marginally stable and are highly susceptible to both chemical and physical degradation. Chemical degradation refers to alterations involving covalent bonds, such as deamidation, oxidation, and disulfide bond shuffling. Physical degradation includes protein unfolding, undesirable adsorption to surfaces, and aggregation. Therefore, efforts to develop advanced drug delivery systems (DDS) for protein-based drugs must include considerations regarding the interactions between the proteins and other DDS components as well as protein stability during product manufacturing, storage and delivery.
It is our goal to develop novel drug delivery systems for proteins and to obtain an understanding of the factors that would influence the stability of proteins in such systems. In particular, we will focus on general characterization of particulate DDS intended for transdermal delivery of proteins using various classes of advanced microneedles. Understanding of the physical interactions in the protein based formulations will be in the center of our activities.