Development of Novel Bioprocess Platform for Rapid, Economical Production of Pept

DESCRIPTION (provided by applicant): A novel bioprocess platform, involving synthesis of peptide and protein biopharmaceutical products as fusions with a synthetic "anchor" protein in bacteria, and subsequent proteolytic cleavage, will be developed. The unique features of the system allow for the economical production of large quantities of simple linear peptides, as well as complex, multi-component peptides. Proof of concept will be demonstrated by synthesizing three peptides of varying sizes; a 12-mer anti-fungal peptide, a 40-mer psalmotoxin, and an 86-mer, pro-insulin. Preliminary studies and cost projections suggest that peptides ranging from about 8 to 100 amino acids can be produced for a few dollars per gram, in contrast to chemical synthetic methods for which costs dramatically increase with the length of the peptide product. Another major advantage is the rapidity with which each product can be generated and the generic nature of the process for many peptide and protein products, facilitating scale-up. Additionally, the three peptide products have their own inherent commercial value. A more efficient bioprocess for human insulin can help meet growing demand. Diabetes is a growing worldwide epidemic that is particularly severe in the U.S and a more efficient bioprocess for human insulin would be immediately useful. This novel, rapid, economical, GMP- enabled bioprocess platform for recombinant peptides and proteins can help meet production requirements, at all levels of production from research quantities to kilograms, in the biopharmaceutical, vaccine, biodefense, and biomedical research industries. The economy and speed with which novel peptides and proteins may be produced from a UBL-type expression system and solid matrix UBL protease fill a great need in industry and could also address some of the government's biodefense requirements for very rapid production of large quantities of vaccines and biopharmaceuticals. Kits for production of peptide libraries based on the UBL expression system could also be of significant value to the biomedical research community. To develop this system and demonstrate its potential, we will synthesize three peptides, each of commercial interest, including human insulin for treatment of diabetes, psalmatoxin peptide for pain research, and MUC7 peptide for treatment of fungal infections.