The purpose of this grant application is to allow Indiana University to continue as a National Gene Vector Laboratory (NGVL) Production Center. We wish to provide service to the gene ?'mtherapy*community.jby;?producing and:distributing clinical: grade-vectors;for-Phase I and n gene transfer protocols. We also propose to continue as the NGVL Coordinating Center.
The Aims of this application include: (1) Generate and certify retroviral vectors intended for clinical use. (2) Generate and certify lentiviral vectors intended for clinical use. (3) Provide scientific and regulatory support for investigators using vectors generated in the NGVL. We will facilitate clinical investigators in preparing their clinically-based Investigation^ New Drug Application (IND), allowing cross-reference to the Indiana University Vector Production Drug Master File. (4) Provide relevant safety tests services to other NGVL centers generating clinical grade material. The Indiana University Vector Production Facility has an extensive experience in the certification of vectors and offers a variety of safety tests performed under Good Laboratory Practice. We will make these assays available to other NGVL centers who might otherwise need to outsource this work. (5) To administrate 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-investigatorsresponsibilities 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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