IGF::OT::IGF - Gene Therapy Resource Program (GTRP) Lentivirus Vector Production

Indiana University Indianapolis, Indianapolis IN

Investigators

Abstract

The Lentiviral vector production core laboratory contract involves production of scalable clinical grade Lentiviral vectors, in accordance with Good Manufacturing Practices (GMP), as defined by the Food and Drug Administration (FDA), and applicable State and Federal regulations, for use by NHBLI funded investigators. It is expected that the contractor will produce an average of Twelve (12) vector batches per year for a minimum of three (3) batches for clinical studies or for safety and efficacy/dose/pharmacology/toxicology testing with large animal models.