ESTABLISHMENT OF ADENOVIRAL VECTOR PRODUCTION LAB AT BAYLOR

贝勒建立腺病毒载体生产实验室

• 批准号: 7360455
• 负责人: MALCOLM K. BRENNER
• 金额: $ 51.43万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-01 至 2007-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7360455
• 关键词: ESTABLISHMENT; ADENOVIRAL; VECTOR; PRODUCTION; LAB

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. DESCRIPTION (provided by applicant): The Center for Cell and Gene Therapy (CAGT) at BCM has considerable expertise in all aspects of adenoviral vector technology, from design of vector constructs, through current Good Manufacturing Practices (cGMP), to clinical applications, and associated quality assurance/control and regulatory issues. The Vector Production Laboratory (VPL) has manufactured 91 lots of research grade adenoviral vector and 21 lots of clinical grade vectors encoding seven gene products. It has provided vectors for 19 gene therapy Investigational New Drug (IND) studies at BCM alone, and has recently scaled-up operations to increase production capacity, that would allow it to produce 12-15 lots/year for NGVL investigators.

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。描述（由申请人提供）：美国加州大学伯克利分校的细胞和基因治疗中心（CAGT）在腺病毒载体技术的各个方面都有相当丰富的专业知识，从载体构建体的设计，到目前的良好生产规范（cGMP），再到临床应用，以及相关的质量保证/控制和监管问题。载体生产实验室（VPL）已经生产了91批研究级腺病毒载体和21批临床级载体，编码7种基因产物。该公司已为19项基因治疗新药研究提供载体，最近还扩大了生产规模，以提高生产能力，使其能够为NGVL研究人员生产12-15批/年。