cGMP and cGLP Lentiviral Vetors

慢病毒载体生产的复杂性和专业性为核心A，即 CGMP和GLP慢病毒载体核心。载体核心的任务是提供临床级别的慢病毒 为项目1提供研究等级向量，并为项目2和3提供研究级别向量。具有既定的轨道 记录，该载体核心已作为合作者和临床慢病毒载体核心的大学 自2001年以来一直在宾夕法尼亚州。这种合作导致了慢病毒载体在临床上的第一次应用， 因此，这种合作的继续将确保新的慢病毒载体的快速临床翻译。这个 CORE将成为“基于慢病毒载体的细胞疗法治疗艾滋病毒”的关键组成部分 通过构建和生产所有研究级和临床级载体。目前， VIRxsys公司是唯一一家拥有慢病毒载体纯化工艺的组织 临床应用，FDA允许在人体上进行评估。VIRxsys制作并净化所有 现场矢量，可实现卓越的过程控制和调度自由度。此外，VIRxsys还具有 经验丰富的内部质量控制(QC)和质量保证(QA)部门，用于测试和 发布研究级和临床级材料。VIRxsys的科学家们还拥有广泛的 在转导(将载体运送到靶细胞)和使用其慢病毒转导方面的经验 在大规模细胞处理过程中提供载体，并将在需要时提供技术专业知识。

The complexity and specialization of lentiviral vector production provide a strong rationale for Core A, the cGMP and GLP Lentiviral Vector Core. The mission of the vector core is to provide clinical grade lentiviral vectors for Project 1, and to provide research grade vectors for Projects 2 and 3. With an established track record, this vector core has served as a collaborator and clinical lentiviral vector core for the University of Pennsylvania since 2001. This collaboration led to the first application of lentiviral vectors in the clinic, and therefore, continuation of this collaboration will ensure rapid clinical translation of new lentiviral vectors. The core will serve as a critical component of the "Lentiviral Vector-based cellular therapy for treatment of HIV infection" through construction and production of all research grade and clinical grade vectors. Presently, VIRxSYS Corporation is the only organization that has a process for purification of lentiviral vectors for clinical application, which is allowed by the FDA for evaluation in humans. VIRxSYS makes and purifies all vector on site, which allows for excellent process control and scheduling freedom. In addition, VIRxSYS has well-seasoned Quality Control (QC) and Quality Assurance (QA) departments in house, for testing and release of both research grade and clinical grade materials. The scientists at VIRxSYS also have extensive experience in the area of transduction (delivery of vector to target cells), and transduction using its lentiviral vector during large scale cell processing, and will provide technical expertise whenever requested.