Large Scale Manufacturing of B43(Anti-CD19)-Genistein for Clinical Trials in Leukemia and Lymphoma |
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| Authors: | Dorothea E Myers Andrew Sicheneder Dina Clementson Nancy Dvorak Taracad Venkatachalam Alexander Rostov Sev Mridula Chandan-Langlie Fatih M Uckun |
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| Institution: |
a Wayne Hughes Institute, St. Paul, MN and Alexander & Parker Corporation, Glendale, CA, USA |
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| Abstract: | We have conjugated the murine monoclonal anti-CD 19 antibody B43 to the tyrosine kinase inhibitor genistein to construct an effective immunoconjugate against CD 19 antigen positive hematologic malignancies. The scaled-up production and purification of B43 antibody, genistein, and B43-Genistein immunoconjugate permitted the manufacturing of a highly purified clinical-grade B43-Genistein preparation. In clonogenic assays, B43-Genistein elicited selective and potent cytotoxicity against CD 19 antigen positive human leukemia cells. To our knowledge, this work represents the first effort of producing a clinical-grade genistein immunoconjugate for treatment of B-lineage leukemia and lymphoma. |
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| Keywords: | Large scale manufacturing B43 (anti-CD19)-genistein clinical trials leukemia & lymphoma |
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