New Opportunities: Biomolecule Production Laboratory

新机遇：生物分子生产实验室

• 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
• 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

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)将提供一个关键的基础设施组件 (CORE D)新英格兰地区生物防御卓越中心(NERCE)。BMPCF将 由一个最先进的实验室组成，其任务是大规模生产和提纯 具有生物防御作用的分子包括蛋白质、毒素亚单位、抗原肽、碳水化合物和 其他生物制品。选择用于生产和纯化的分子将是那些被发现对 NERCE的使命将包括疫苗成分、疗法和抗原 免疫分析和诊断学。BMPCF将有能力在细菌、酵母、 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操作规范下运行 指南，以便每个生物分子的制造方案将适合纳入 如有必要，调查新药申请。BMPCF将有能力生产 具有足够数量和纯度的生物分子，可用于临床前和早期 I期临床试验。因此，BMPCF旨在提供翻译能力，以弥合差距 介于研究性实验室和大规模商业化生产之间。BMPCF的核心将是 由两位拥有29年生产经验的资深科学家管理 第一阶段人体试验的免疫原。所有NERCE调查人员和整个I区的调查人员 从事联邦支持的生物防御项目将可以获得BMPCF的服务。这个 BMPCF还将与其他NERCE核心密切合作，如蛋白质组学、小分子测试和 管理部门确保有足够数量的限速生物制品可用于支持所有 相关的NERCE研究和开发项目。该设施还将被规划为允许其迅速 重新装备，以便在发生国家生物防御紧急情况时进行有针对性的新努力 与NIAID协商。