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, has been 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. Preliminary studies and cost projections suggest that peptides ranging from about 15 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. This novel, rapid, economical bioprocess platform for recombinant peptides and proteins can help meet production requirements, at all levels of production from research quantities to many kilograms, in the biopharmaceutical, vaccine, biodefense, and biomedical research industries. PUBLIC HEALTH RELEVANCE: A novel production platform is being developed and specifically tailored for the rapid, scaleable, and economical synthesis of large peptides and small proteins for which chemical synthesis and existing recombinant methods are not feasible. The technology addresses a significant unmet need for production of peptide product candidates in the 20-100 amino acid size range. There are numerous commercial applications for this technology in manufacturing of peptide therapeutics and vaccines, in conformational epitope discovery and production (for biodefense), and in biomedical research. The platform may even be cost efficient enough to help retain bio-manufacturing capacity in the US, despite the pressures of cheaper labor and operating costs elsewhere in the global economy. The platform also represents an environmentally friendly alternative to chemical peptide synthesis, which generates large volumes of organic waste.