Vector Core

矢量核心

基本信息

批准号：
7802299
负责人：
JULIE JOHNSTON
金额：
$ 14万
依托单位：
UNIVERSITY OF PENNSYLVANIA
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-04-01 至 2012-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7802299
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 Guidelines Laboratories Lentivirus Vector Link Location Maps Mediating Methodology Methods Molecular Biology Outcome Pennsylvania Phase I Clinical Trials Procedures Process Production Quality Control Reagent Regulation Research Research Personnel Resources Scientist Screening procedure Series Serotyping Services Somatic Gene Therapy Subfamily lentivirinae Technology Time Time Study Tissues Training Universities Validation Viral Vector base design experience gene therapy good laboratory practice improved in vivo innovation interest large scale production meetings 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.

向量核心宾夕法尼亚大学的矢量核心是一个独立且全方位的实验室，提供基因转移领域的试剂和专业知识。这个称为“ Penn Vector”的设施由Julie博士执导。约翰斯顿（Johnston）在AAV，腺病毒和慢病毒生产地区管理7位科学家。这个程序将专注于利用Penn Vector来生产AAV向量，该向量将为III的III提供服务。马丁·洛克（Martin Lock）执导的独立质量控制计划执行了一系列必要的测定用于释放体内研究的载体。该核心还将分析组织是否存在使用Taqman和PCR技术的基因组。最后，向量核心将调整现有方法为临床候选者制造和净化，以使大规模生产高效到足以在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可以开发。实验室根据GLP的一般原则进行操作，包括文档（记录表格），SOP，QA/QC，培训和设备验证，尽管它不代表自己为完全GLP或GMP。外行描述。 P01中使用的所有向量将是。由向量核心创建和生产。