High throughput protein stability analysis systems for biopharma

To ensure product safety and efficacy, protein therapeutic critical quality attributes must remain within tolerances for the duration of the shelf life of the product, as well as during transportation, storage and use. Consequently, development of and testing for long term stability of the protein drug product is a major focus of biotherapeutic development and formulation activities. Thermodynamic stability of the higher order structure of the protein is used as a proxy for longer term stability of the drug product, allowing many potential formulation conditions or variants of the drug product to be screened in a time period significantly shorter than the potential shelf life, greatly increasing the speed the drug can be developed and commercialised. This project is to develop a new high throughput technology for the screening of protein stability that requires very little sample and is able to be extensively automated. The target market will be biopharmaceutical development and formulation, allowing much higher numbers of drug candidate variants or formulation conditions to be screened earlier in the development cycle.