New Opportunities: Biomolecule Production Laboratory

新机遇：生物分子生产实验室

基本信息

批准号：
7645445
负责人：
ROBIN A ROSS
金额：
$ 24.86万
依托单位：
HARVARD MEDICAL SCHOOL
依托单位国家：
美国
项目类别：
财政年份：
2008
资助国家：
美国
起止时间：
2008-03-01 至 2009-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7645445
关键词：
Affinity Affinity Chromatography Antigens Arts Binding Biological Biological Assay Buffers Carbohydrates Cells Charge Chemicals Clinical Trials Codon Nucleotides Collaborations Consultations Core Facility Crude Extracts Development Diagnostic Dimensions Disruption Drug Delivery Systems Emergency Situation Endopeptidases Endotoxins Event Excision Freeze Drying Gel Chromatography Genes Growth Harvest Health Services Accessibility High Pressure Liquid Chromatography Human Hydrophobic Interactions Immune Sera Immunoassay Insecta Investigational New Drug Application Ion Exchange Ion-Exchange Chromatography Procedure Label Laboratories Laboratory Research Lipids Location Mammalian Cell Methodology Methods Mission Molecular Weight Monitor National Institute of Allergy and Infectious Disease New England Nucleic Acids Peptide Hydrolases Peptides Performance Phase Phase I Clinical Trials Pilot Projects Polysaccharides Practice Guidelines Preparation Process Production Protein Glycosylation Proteins Proteomics Protocols documentation Rate Research Research Personnel Senior Scientist Services Staging Standards of Weights and Measures System Techniques Technology Testing Therapeutic Time Toxin Translational Research Vaccine Antigen Vaccines Vision Work Yeasts base biodefense biological research design desire experience gel electrophoresis gene cloning interest nuclease pre-clinical protein expression protein purification scale up size small molecule vector

项目摘要

The Biological Molecule Production Core Facility (BMPCF) will provide a key infrastructural component (Core D) for New England Regional Center of Excellence in BioDefense (NERCE). The BMPCF will consist of a state-of the-art laboratory whose mission will be the large scale production and purification of molecules of biodefense importance including proteins, toxin subunits, antigenic peptides, carbohydrates and other biologics. The molecules selected for production and purification will be those found to be important to the mission of NERCE and thus will include vaccine components, therapeutics, and antigens for immunoassay and diagnostics. The BMPCF will have the capacity to produce proteins in bacterial, yeast, insect cell, and mammalian cell expression systems. The core will operate under Good Laboratory Practice guidelines, so that the manufacturing protocols for each biological molecule will be appropriate for inclusion into Investigational New Drug applications, as necessary. The BMPCF will be capable of producing biological molecules in sufficient quantity and purity that they could be used for preclinical as well as early Phase I clinical trials. Thus, the BMPCF is intended to provide translational capacity to bridge the gap between the research laboratory and large-scale commercial production. The BMPCF core will be administered by two senior scientists that have 29 years of collective experience in the production of immunogens for Phase I human testing. All NERCE investigators and investigators throughout Region I working on federally supported biodefense projects will have access to the services of the BMPCF. The BMPCF will also work closely with other NERCE cores such as the Proteomics, Small Molecule Testing, and Administration to assure that adequate amounts of the rate-limiting biologics are available to support all relevant NERCE research and developmental projects. The facility will also be planned to allow its rapidly retooling for targeted new efforts in the event of a national biodefense emergency as determined by consultation with NIAID.

生物分子生产核心设施（BMPCF）将提供关键的基础设施组件（核心D）新英格兰地区卓越生物福利卓越中心（Nerce）。 BMPCF会由最先进的实验室组成，其使命将是大规模生产和净化生物浮雕的分子重要性包括蛋白质，毒素亚基，抗原肽，碳水化合物和其他生物制剂。选择用于生产和纯化的分子对 Nerce的使命，因此包括疫苗成分，治疗剂和抗原免疫测定和诊断。 BMPCF将具有在细菌，酵母中产生蛋白质的能力昆虫细胞和哺乳动物细胞表达系统。核心将在良好的实验室实践下运作准则，以便每个生物分子的制造方案都适合纳入必要时进入研究性新药应用。 BMPCF将能够生产足够数量和纯度的生物分子可用于临床前和纯度 I期临床试验。因此，BMPCF旨在提供翻译能力以弥合差距在研究实验室和大规模商业生产之间。 BMPCF核心将是由两位高级科学家管理，在生产中拥有29年的集体经验 I期人类测试的免疫原子。 I地区的所有NERCE调查人员和调查人员从事联邦支持的生物形式项目将可以访问BMPCF的服务。这 BMPCF还将与其他尼尔核心紧密合作，例如蛋白质组学，小分子测试和管理以确保足够数量的限速生物制剂可以支持所有人相关的尼尔研究和发展项目。该设施还计划允许其迅速在发生国家生物陷入紧急事件的情况下，对有针对性的新努力进行重新处理。与Niaid协商。