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.