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

描述（由申请人提供）：已经开发了一个新的生物工艺平台，涉及合成多肽和蛋白质生物制药产品，作为与细菌中合成的“锚”蛋白的融合，以及随后的蛋白水解裂解。该系统的独特功能允许经济生产大量简单的线性肽，以及复杂的多组分肽。初步研究和成本预测表明，生产15到100个氨基酸的肽每克只需几美元，而化学合成方法的成本则随着肽产品的长度而急剧增加。另一个主要优点是每个产品都可以快速生成，并且许多肽和蛋白质产品的过程具有通用性质，便于扩大规模。这种新型、快速、经济的重组肽和蛋白质生物工艺平台可以帮助满足生物制药、疫苗、生物防御和生物医学研究行业从研究数量到数公斤的所有生产水平的生产要求。公共卫生相关性：正在开发一种新的生产平台，专门用于快速、可扩展和经济地合成化学合成和现有重组方法无法实现的大肽和小蛋白质。该技术解决了在20-100个氨基酸大小范围内生产肽候选产品的重大未满足需求。这项技术在多肽疗法和疫苗的制造、构象表位的发现和生产（用于生物防御）以及生物医学研究方面有许多商业应用。尽管全球经济中其他地方的劳动力和运营成本更低，但该平台甚至可能具有足够的成本效益，有助于保留美国的生物制造能力。该平台也代表了一种环境友好的替代化学肽合成，产生大量的有机废物。

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.