A gene therapy core facility is proposed to facilitate clinical trials studies. The facility will perform and oversee FDA and RAC required safety testing for patients participating in gene therapy trials at Indiana University. The core will also contain a shared vector production facility which will supply viral vector for clinical protocols. A facility capable of producing and testing retroviral and adeno-associated viral vectors will be housed in the Cancer Research Building and will occupy 1800 sq. feet of space. The laboratory is specifically designed for the production of clinical grade viral vector under Good Laboratory and Good Manufacturing Practice criteria (GLP and GMP). Clinical grade supernate will be produced by a technician with experience in GMP production and a technician with experience in retroviral vector testing. The facility will be overseen by an investigator who has successfully written Investigational New Drug (IND) applications for retroviral vectors and is currently conducting clinical trials using retroviral vectors. Funding is requested for supplies and technical personnel to perform FDA required safety testing of clinical samples obtained from patients enrolled in gene therapy trials. The laboratory will also provide support for vector production, although investigators will be required to contribute funds to cover the cost of supplies used in vector production and testing. The laboratory will play a critical role in vectors development, allowing the generation of promising vectors in a timely fashion and by providing standardized safety testing for trial participants.
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