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).
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.
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