TAT-10: Quality Assurance and Labeling Chemistry Qualification for cGMP Production of Astatine-211-labeled anti-CD45 Antibodies

Kanazawa, Japan (UroToday.com) For a drug to be used on humans the US Food and Drug Administration requires current Good Manufacturing Practice (cGMP), a set of regulations that assure proper design, monitoring,  and control of manufacturing, process, and facilities. The objective of research reported here is to set up procedures to translate the production of At211-labeled anti-CD45 antibodies from benchtop to cGMP-compliant results. This requires demonstration of purity, safety, and sterility of compound produced under cGMP conditions.

The initial extraction of At211 from a bismuth target was accomplished using wet chemistry in a non-cGMP facility. After certification by analysis, the radioisotope was moved to a cGMP facility for conjugation, three consecutive runs produced 0.67 – 1.19 GBq of At211-BC8-B10 with 45 – 78% isolated radiochemical yield. The At211-labeled antibodies where 98% pure and found to be sterile.

In conclusion, we have demonstrated that the highest level of patient doses can be produced under the cGMP conditions required for eventual FDA approval

Presented By: D. Scott Wilbur from University of Washington and Fred Hutchinson Cancer Research Center, Seattle, Washington

Written By: William Carithers, Lawrence Berkeley National Laboratory

at the 10th International Symposium on Targeted Alpha Therapy (TAT-10)  May 31 - June 1, 2017 - Kanazawa, Japan.
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