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中文摘要
翻译
向量核心 宾夕法尼亚大学的向量核心实验室是一个独立的全方位服务实验室,提供 基因转移领域的试剂和专业知识。这个名为“宾夕法尼亚矢量”的机构是由朱莉博士指导的 约翰斯顿在AAV、腺病毒和慢病毒生产领域管理着7名科学家。本节目 将重点利用宾夕法尼亚病媒生产AAV病媒,为项目I至III提供服务 马丁·洛克博士领导的独立质量控制程序进行了一系列必要的分析 用于释放载体,用于体内研究。这个核心还将分析组织中是否存在载体 利用TaqMan和聚合酶链式反应技术进行基因组分析。最后,向量核心将改编现有的方法 制造和提纯到临床候选的大规模生产的效率足以 在第一阶段研究中支持大型动物。支持最终临床生产所需的分析将 也被开发出来。实验室在GLP的一般原则下运行,包括文件 (批次记录表)、SOP、QA/QC、培训和设备验证,但不代表其本身 作为完全的GLP或GMP。 版面描述。P01中使用的所有向量都将是。由向量核心创建和制作。
英文摘要
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.
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GENE THERAPY RESOURCE PROGRAM (GTRP): TASK AREA B FOR PRECLINICAL VECTOR CORE LABORATORY SCIENTIFIC ACTIVITIES
  • 批准号:
    10725221
  • 项目类别:
  • 资助金额:
    $79.61万
  • 财政年份:
    2022
  • 负责人:
    JULIE JOHNSTON
  • 依托单位:
GENE THERAPY RESOURCE PROGRAM (GTRP): TASK AREA B FOR PRECLINICAL VECTOR CORE LABORATORY SCIENTIFIC ACTIVITIES
  • 批准号:
    10788012
  • 项目类别:
  • 资助金额:
    $62.81万
  • 财政年份:
    2022
  • 负责人:
    JULIE JOHNSTON
  • 依托单位:
Vector Core
  • 批准号:
    7595332
  • 项目类别:
  • 资助金额:
    $20.43万
  • 财政年份:
    2009
  • 负责人:
    JULIE JOHNSTON
  • 依托单位:
Vector Core
  • 批准号:
    7450502
  • 项目类别:
  • 资助金额:
    $12.29万
  • 财政年份:
    2008
  • 负责人:
    JULIE JOHNSTON
  • 依托单位:
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