Core B: Pharmaceutical Production

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PROJECT SUMMARY / ABSTRACT – CORE B Core B, Pharmaceutical Production, is responsible for the production of the monoclonal antibodies (MAbs), the antibody conjugates, the alpha-emitting radionuclide astatine-211 (211At) and the 211At-labeled antibody conjugates. The Core will produce anti-CD45 and anti-CD38 MAbs used in preclinical studies (Projects 1, 2 and 3) and produce clinical grade anti-human CD45 BC8 MAb and anti-human CD38 OKT10 MAb used in clinical trials (Projects 2 and 3). The MAbs will be conjugated with a novel reagent (B10-NCS) to produce MAb-B10 conjugates for radiolabeling with astatine-211 (211At). All MAbs and clinical grade reagents will be produced, purified and vialed in the Biologics Production Facility (BPF) of the Fred Hutch. The B10-NCS reagent and MAb-B10 conjugates used for preclinical studies will be produced in appropriate chemical laboratories at the University of Washington. Clinical grade BC8-B10 conjugate and OKT10-B10 will be produced, purified and vialed under current good manufacturing practice (cGMP) conditions in the Fred Hutch BPF. Production, isolation and purification of the 211At will be done in the UW Medical Cyclotron Facility and UW Radionuclide Production Laboratory. The 211At-MAb-B10 for preclinical studies will be conducted in UW radiochemistry laboratory, and 211At-BC8-B10 and 211At-OKT10-B10 used in the clinical trials will be produced in a cGMP facility at UW. Testing of the materials produced will be conducted at UW or Fred Hutch, depending on the assay. Patient samples obtained from Projects 2 and 3 will be collected, processed and stored at the Fred Hutch for use in Project 1.