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

开发用于快速、经济生产肽的新型生物工艺平台

基本信息

批准号：
7848987
负责人：
APRILE L PILON
金额：
$ 37.5万
依托单位：
APC BIOTECHNOLOGY SERVICES, INC.
依托单位国家：
美国
项目类别：
财政年份：
2007
资助国家：
美国
起止时间：
2007-09-04 至 2011-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7848987
关键词：
Address Affinity Amino Acids Bacteria Binding Biological Assay Biological Products Biomedical Research Cells Chemicals Chimeric Proteins Chitin Chromatography Complex Culture Media Development Dextrans Endotoxins Epitopes Escherichia coli Fermentation Generic Drugs Growth High Pressure Liquid Chromatography Histidine In Vitro Industry Insulin Ions Kilogram Knock-out Laboratories Length Metals Methods Monitor N-terminal Nature Nucleic Acids Peptide Hydrolases Peptide Synthesis Peptides Phase Plant Resins Preparation Process Production Proteins Quality Control Reaction Reagent Recombinants Recovery Research Solubility Streptavidin System Technology Temperature Testing Vaccines Work aqueous biodefense bioprocess chemical synthesis commercial application commercialization cost cost efficient dextran in vivo maltose-binding protein meetings novel novel strategies peptide chemical synthesis pressure prevent public health relevance recombinant peptide scale up therapeutic vaccine tool wasting

项目摘要

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.

描述（由申请人提供）：已经开发了一种新颖的生物工艺平台，涉及肽和蛋白质生物制药产品的合成，与细菌中的合成“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地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，约 15 至 100 个氨基酸的肽的生产成本为每克几美元，而化学合成方法的成本随着肽产品的长度而急剧增加。另一个主要优点是每种产品的生产速度快，而且许多肽和蛋白质产品的工艺过程具有通用性，有利于扩大规模。这种新颖、快速、经济的重组肽和蛋白质生物加工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公斤数的各个生产水平的生产要求。公共健康相关性：正在开发一种新型生产平台，专门用于快速、可规模化且经济地合成大肽和小蛋白质，而化学合成和现有重组方法对此不可行。该技术解决了生产 20-100 个氨基酸大小范围内的候选肽产品的重大未满足需求。该技术在肽治疗剂和疫苗的制造、构象表位发现和生产（用于生物防御）以及生物医学研究方面有许多商业应用。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，尽管全球经济其他地方面临着廉价劳动力和运营成本的压力。该平台还代表了化学肽合成的一种环保替代方案，化学肽合成会产生大量有机废物。