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Introduction: To apply for Clinical Lentivirus Vector Production Services, an investigator must have adequate preclinical data and the requisite regulatory and oversight reviews for the proposed clinical protocol. Additionally, the applicant must demonstrate approved funding for the planned clinical trial in a heart, lung, or blood disease.
FAQs For all types of RSAs
In addition, for Clinical-Grade Lentiviral Vector Production
A Request for Service Application (RSA) is the mechanism for applying for GTRP resources. Investigators must register on-line and be approved by the NHLBI Gene Therapy Group in order to access the Request for Service Application. In order for the laboratory to meet the vector production requirements of the clinical study, the applicant investigator will be asked to provide such information as:
The Indiana University Vector Production Facility (IU VPF) is in the Department of Medical and Molecular Genetics, Indiana University School of Medicine, Indianapolis. The IU VPF has been generating retroviral vectors for over 10 years and has certified over 30 products for clinical use. It has also generated lentiviral vector for clinical use and developed a series of release testing important for certifying vectors. The current facility has two suites dedicated to vector production, with a total of 5 production rooms. Besides an experienced production team, the laboratory has a dedicated certification testing staff that conduct general (ex. sterility, endotoxin, in vitro assay for adventitious agents) and specialized testing (ex. assays for detection of replication-competent lentivirus, and detection of replication-competent retrovirus) focused on assessing the quality of gene therapy products. The IU VPF also has a dedicated molecular diagnostics laboratory performing DNA based assays aimed at assessing the quality and potency of integrating vectors. |
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