ESTABLISHMENT OF ADENOVIRAL VECTOR PRODUCTION LAB AT BAYLOR

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。描述（由申请人提供）：BCM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多的专业知识，从载体构建的设计，通过现行的良好生产规范（cGMP），到临床应用，以及相关的质量保证/控制和监管问题。载体生产实验室共生产了91批科研级腺病毒载体和21批临床级载体，编码了7种基因产物。该公司仅在BCM就为19项基因治疗研究性新药（IND）研究提供了载体，并在最近扩大了生产规模，以提高生产能力，这将使其能够每年为NGVL研究人员生产12-15批次。

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.