Core C is responsible for the production of clinical grade anfi-CD45 BCS antibody and anti CD20 1F5 antibody and their derivatization with DOTA and conjugation to streptavidin. These reagents will be produced, purified and vialed in the Biologies Production Facility of the Fred Hutchinson Cancer Research Center. In addition. Core C will be responsible for cGMP-compliant vialing of DOTA-biotin supplied in bulk form from a contract manufacturer (Macrocyclics, Inc.) Materials will be produced under current good manufactured practice (cGMP) conditions and Drug Master Files (DMFs) have been filed with the Food and Drug Administration (FDA).

Public Health Relevance

Through the refined development of clinical grade anti-CD45 BCS antibody and anti-CD20 1F5 antibody with streptavidin and DOTA, in our dedicated clinical manufacturing facility, the treatment of leukemia and lymphoma may become more successful and less invasive.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Program Projects (P01)
Project #
5P01CA044991-25
Application #
8546164
Study Section
Special Emphasis Panel (ZCA1-RPRB-J)
Project Start
Project End
Budget Start
2013-08-01
Budget End
2014-07-31
Support Year
25
Fiscal Year
2013
Total Cost
$251,610
Indirect Cost
$117,323
Name
Fred Hutchinson Cancer Research Center
Department
Type
DUNS #
078200995
City
Seattle
State
WA
Country
United States
Zip Code
98109
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