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Preparation of clinical‐grade 89 Zr‐panitumumab as a positron emission tomography biomarker for evaluating epidermal growth factor receptor‐targeted therapy
Author(s) -
Wei Ling,
Shi Jianfeng,
Afari George,
Bhattacharyya Sibaprasad
Publication year - 2014
Publication title -
journal of labelled compounds and radiopharmaceuticals
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.432
H-Index - 47
eISSN - 1099-1344
pISSN - 0362-4803
DOI - 10.1002/jlcr.3134
Subject(s) - panitumumab , positron emission tomography , epidermal growth factor receptor , chemistry , monoclonal antibody , colorectal cancer , cancer research , nuclear medicine , cetuximab , cancer , medicine , oncology , receptor , antibody , biochemistry , immunology
Panitumumab is a fully human monoclonal antibody approved for the treatment of epidermal growth factor receptor (EGFR) positive colorectal cancer. Recently, panitumumab has been radiolabeled with 89 Zr and evaluated for its potential to be used as immuno‐positron emission tomography (PET) probe for EGFR positive cancers. Interesting preclinical results published by several groups of researchers have prompted us to develop a robust procedure for producing clinical‐grade 89 Zr‐panitumumab as an immuno‐PET probe to evaluate EGFR‐targeted therapy. In this process, clinical‐grade panitumumab is bio‐conjugated with desferrioxamine chelate and subsequently radiolabeled with 89 Zr resulting in high radiochemical yield (>70%, n = 3) and purity (>98%, n = 3). All quality control (QC) tests were performed according to United States Pharmacopeia specifications. QC tests showed that 89 Zr‐panitumumab met all specifications for human injection. Herein, we describe a step‐by‐step method for the facile synthesis and QC tests of 89 Zr‐panitumumab for medical use. The entire process of bioconjugation, radiolabeling, and all QC tests will take about 5 h. Because the synthesis is fully manual, two rapid, in‐process QC tests have been introduced to make the procedure robust and error free. Copyright © 2013 John Wiley & Sons, Ltd.