An Instrument to Determine Protein Stability for Biologics Formulations Testing

DESCRIPTION (provided by applicant): Protein therapeutics is the fastest growing segment in the biotechnology and pharmaceutical industry with annual sales totaling over 70 billion. Protein therapeutics includes monoclonal antibodies, recombinant proteins, chimeric proteins and other protein receptor constructs. A major hurdle in the development of proteins as pharmaceutical drugs is their formulation in a safe and stable form. The identification of buffer, ligand and excipient conditions that maximize their stability and eliminate protein aggregation is critical during development and often requires the evaluation of hundreds of conditions. This time-consuming task is compounded by the absence of completely automated instruments with the capability of accurately measuring the stability/aggregation matrix of a protein. The goal of this proposal is to develop a fully automated, protein chemical denaturation, fluorescence instrument aimed at measuring multi- dimensional protein stability and aggregation matrices. Unlike any other currently available instrument, this instrument will be capable of automatically preparing and analyzing up to 96 protein denaturation curves - enough to complete an entire formulations study for a new biologic. In this instrument, the user will only need to provide protein and bulk formulation solutions. The instrument will automatically prepare all solutions, perform the measurements, analyze the data and present the results to the investigator. PUBLIC HEALTH RELEVANCE: This instrument will significantly accelerate the development of protein therapeutics and find a significant market. In addition, it will provide a new way to study protein stability and aggregation, and contribute to the development of a better scientific understanding of these issues. By providing a rapid and cost-effective means to automatically conduct an entire Formulations Study at relevant temperatures (storage and biological), researchers will have the practical opportunity to test more Formulations and to select the Formulation that is optimal for any specific biologic.