Synthesis of USP-Grade 89Zr-Panitumumab for Medical Use
A robust protocol has been developed for producing clinical-grade 89Zr-panitumumab as an immuno-PET probe to evaluate EGFR- targeted therapy. In this protocol, clinical-grade panitumumab is bio-conjugated with desferrioxamine chelate and subsequently radiolabeled with 89Zr resulting in high radiochemical yield (> 70 %, n = 3) and purity (> 98%, n = 3). All quality control (QC) tests were performed according to USP specifications (USP general chapter <823>). QC tests showed that the 89Zr-panitumumab met all specifications for human injection. This protocol describes a step-by-step method for the facile synthesis and quality control tests of 89Zr-panitumumab for medical use. The entire process of bioconjugation, radiolabeling, and all QC tests take about 5 h.
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Posted 26 Sep, 2013
Synthesis of USP-Grade 89Zr-Panitumumab for Medical Use
Posted 26 Sep, 2013
A robust protocol has been developed for producing clinical-grade 89Zr-panitumumab as an immuno-PET probe to evaluate EGFR- targeted therapy. In this protocol, clinical-grade panitumumab is bio-conjugated with desferrioxamine chelate and subsequently radiolabeled with 89Zr resulting in high radiochemical yield (> 70 %, n = 3) and purity (> 98%, n = 3). All quality control (QC) tests were performed according to USP specifications (USP general chapter <823>). QC tests showed that the 89Zr-panitumumab met all specifications for human injection. This protocol describes a step-by-step method for the facile synthesis and quality control tests of 89Zr-panitumumab for medical use. The entire process of bioconjugation, radiolabeling, and all QC tests take about 5 h.
Figure 1
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