cGMP and cGLP Lentiviral Vetors

慢病毒载体生产的复杂性和专业化为核心A提供了强有力的理论基础， cGMP和GLP慢病毒载体核心。载体核心的使命是提供临床级的慢病毒 为项目1提供研究等级矢量，并为项目2和3提供研究等级矢量。有了既定的轨道 记录，这个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，宾夕法尼亚这项合作导致了慢病毒载体在临床上的首次应用， 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。的 核心将作为“用于治疗HIV的慢病毒载体细胞疗法”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来实现“感染”。目前， VIRxloveCorporation是唯一一家拥有慢病毒载体纯化工艺的公司， 临床应用，FDA允许用于人体评价。VIRxandroid制造并净化了所有 现场矢量，可实现出色的过程控制和调度自由度。此外，VIRxtek还拥有 内部经验丰富的质量控制（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。VIRxtube的科学家们也有广泛的 在转导领域（将载体递送至靶细胞）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，我们将提供技术支持，并将在需要时提供技术专长。

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.