CORE--VIRUS

$0P01FY2001HLNIH

Indiana Univ-Purdue Univ At Indianapolis, Indianapolis IN

Investigators

Linked publications & trials

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Abstract

A shared vector production facility is proposed which will supply clinical grade viral vector for the projects participating in this program. The core will also supply FDA and RAC required safety testing for patients participating in clinical gene therapy trials. 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. 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. The laboratory will play a critical role in bringing the viral vectors developed in this project to clinical trial.

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