The purpose of this grant application is to allow IU to continue as a NGVL production center. The investigators wish to provide service to the gene therapy community by producing and distributing clinical grade vectors for Phase I/II gene transfer protocols. They also propose to continue as the NGVL Coordinating Center.
The aims of this application include: generate and certify retroviral vectors intended for clinical use; generate and certify lentiviral vectors intended for clinical use; and provide scientific and regulatory support for investigators using vectors generated in the NGVL. They will facilitate clinical investigators in preparing their clinically-based Investigational New Drug Application (IND), allowing cross-reference to the IU Vector Production Drug Master File. They will provide relevant safety tests services to other NGVL centers generating clinical grade material. The IU vector production facility has an extensive experience in the certification of vectors and offers a variety of safety tests performed under Good Laboratory Practice. They will make these assays available to other NGVL centers who might otherwise need to outsource this work. Finally, they will administer the NGVL Coordinating Center. The Coordinating Center will coordinate the meetings of the NGVL Review Committee and Steering Committee, process investigator requests for NGVL services, oversee compliance with investigators responsibilities as described in the NGVL Policy and Procedures Manual, maintain the NGVL Toxicology Master File(s), and collect post-distribution monitoring data from all NGVL-funded investigators.
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