- CORE B Core B is responsible for the production of clinical grade anti-human CD45 BC8 antibody (Projects 2 and 3). The 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 B will be responsible for the establishment of an IND to support conduct of Phase I human clinical trials. Core B will also be responsible for radiolabeling anti-canine ICOS with 123I and 211At which are required for biodistribution and therapy studies respectively for Project 1. The anti-ICOS antibody itself will be produced using resources supplied to Project 1.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Program Projects (P01)
Project #
2P01CA078902-16
Application #
8742468
Study Section
Special Emphasis Panel (ZCA1-RPRB-J (M1))
Project Start
2000-03-31
Project End
2019-08-31
Budget Start
2014-09-02
Budget End
2015-08-31
Support Year
16
Fiscal Year
2014
Total Cost
$322,320
Indirect Cost
$80,087
Name
Fred Hutchinson Cancer Research Center
Department
Type
DUNS #
078200995
City
Seattle
State
WA
Country
United States
Zip Code
98109
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