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Vector Core

矢量核心

基本信息

批准号：
7450502
负责人：
JULIE JOHNSTON
金额：
$ 12.29万
依托单位：
UNIVERSITY OF PENNSYLVANIA
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：
2008-04-01 至 2012-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7450502
关键词：
Adenovirus Vector Adenoviruses Animals Archives Area Arts Basic Science Biodistribution Biological Assay Clinical Control Groups Databases Dependovirus Development Disease Documentation Equipment Gene Delivery Gene Transfer Generations Genome Guanosine Monophosphate Guidelines Laboratories Lentivirus Vector Link Location Maps Mediating Methodology Methods Molecular Biology Numbers Outcome Pennsylvania Phase I Clinical Trials Polymerase Chain Reaction Procedures Process Production Quality Control Range Reagent Regulation Research Research Personnel Resources Scientist Screening procedure Series Serotyping Services Somatic Gene Therapy Standards of Weights and Measures Subfamily lentivirinae Technology Time Time Study Tissues Training Universities Validation Viral Vector base design experience gene therapy improved in vivo innovation interest novel preclinical study programs quality assurance repository urea cycle vector vector genome

项目摘要

Vector Core The Vector Core at the University of Pennsylvania is an independent and full service laboratory providing reagents and expertise in the area of gene transfer. This facility called "Penn Vector" is directed by Dr. Julie Johnston who manages 7 scientists in the area of AAV, adenovirus and lentiviral production. This program will focus on utilization of Penn vector for the production of AAV vectors that will service Projects I through III An independent Quality Control Program directed by Dr. Martin Lock performs a series of assays necessary for release of the vector for in vivo studies. This core will also analyze tissues for presence of vector genomes using TaqMan and PCR technology. Finally, the Vector Core will adapt existing methods of manufacturing and purification to the clinical candidate for a large scale production efficient enough to support large animals in a Phase 1 study. Assays necessary to support the ultimate clinical production will also be developed. The laboratory operates under the general principles of GLP including, documentation (batch record forms), SOPs, QA/QC, training and equipment validation, although it does not represent itself as being fully GLP or GMP. Lay description. All vectors used in the P01 will be. created and produced by the Vector Core.

Vector Core 宾夕法尼亚大学的Vector Core是一个独立的全方位服务实验室，基因转移领域的试剂和专业知识。这个名为“Penn Vector”的设施由朱莉博士约翰斯顿，他管理着AAV、腺病毒和慢病毒生产领域的7位科学家。这个程序将集中于利用Penn载体生产AAV载体，这些载体将服务于项目I至III 由Martin Lock博士指导的独立质量控制程序执行一系列必要的测定用于释放载体用于体内研究。该核心还将分析组织中是否存在载体利用TaqMan和PCR技术进行基因组测序。最后，Vector Core将采用现有的方法，用于大规模生产的临床候选药物的生产和纯化足够有效，在1期研究中支持大型动物。支持最终临床生产所需的测定将也要发展。实验室在GLP的一般原则下运行，包括文件（批记录表）、SOP、QA/QC、培训和设备验证，但不代表其自身符合GLP或GMP标准。 Lay描述。P01中使用的所有载体均为。由矢量核心创造和生产。