cGMP and cGLP Lentiviral Vetors

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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.