Core C: Pharmaceutical Production

Fred Hutchinson Cancer Research Center, Seattle WA

Investigators

Linked publications & trials

Abstract

ABSTRACT ? CORE C Core C is responsible for the production of clinical grade anti-human CD45 BC8 antibody (Project 1) and anti- canine CD45 (CA12.10C12) for pre-clinical use (Projects 2 and 3). Each antibody will be conjugated with a reagent (B10-NCS) for radiolabeling with astatine-211. All antibodies and clinical grade reagents will be produced, purified and vialed in the Biologics Production Facility of the Fred Hutchinson Cancer Research Center. Pre-clinical and clinical radiolabeling reactions will be conducted in appropriate radiochemistry laboratories at the University of Washington. Clinical grade BC8-B10 will be produced under current good manufacturing practice (cGMP) conditions and a Drug Master File will be developed and submitted to the Food and Drug Administration. In addition, Core C will be responsible for the establishment of an IND to support conduct of Phase I human clinical trials.