TY - JOUR
T1 - An inductively coupled plasma mass spectrometry method for the quantification of yttrium-antibody based drugs using stable isotope tracing
AU - Ciavardelli, Domenico
AU - D'Anniballe, Gaetano
AU - Nano, Giuseppe
AU - Martin, Franck
AU - Federici, Giorgio
AU - Sacchetta, Paolo
AU - Di Ilio, Carmine
AU - Urbani, Andrea
PY - 2007
Y1 - 2007
N2 - Targeted radioimmunotherapy has been recently clinically validated and approved for the treatment of cancer by the US Food and Drug Administration. This therapeutic approach employs monoclonal antibodies directed to cancer-related, cell-surface antigens coupled to β-emitting nuclides. 90Y is one of the most useful radioisotopes in the development of antibody based radioimmunotherapy and evaluation of the pharmacokinetic profile for 90Y-radiopharmaceuticals is usually performed by radiochemical methods. In this work we have developed an alternative radioactive-free approach to evaluate pharmacokinetic profiles based on the inductively coupled plasma mass spectrometric (ICP-MS) quantification of 89Y. A highly sensitive and rapid method for the determination of yttrium in urine is described and applied to evaluate the urinary clearance of antibody-based drugs labeled with the stable isotope of yttrium, 89Y. This approach overcomes some important limitations for pre-clinical radioanalytical methods such as radiation hazards and radioactive waste disposal. Method development was performed by determining detection and quantification limits, and precision as repeatability and trueness. These performance parameters fulfilled the acceptance criteria for bioanalytical methods.
AB - Targeted radioimmunotherapy has been recently clinically validated and approved for the treatment of cancer by the US Food and Drug Administration. This therapeutic approach employs monoclonal antibodies directed to cancer-related, cell-surface antigens coupled to β-emitting nuclides. 90Y is one of the most useful radioisotopes in the development of antibody based radioimmunotherapy and evaluation of the pharmacokinetic profile for 90Y-radiopharmaceuticals is usually performed by radiochemical methods. In this work we have developed an alternative radioactive-free approach to evaluate pharmacokinetic profiles based on the inductively coupled plasma mass spectrometric (ICP-MS) quantification of 89Y. A highly sensitive and rapid method for the determination of yttrium in urine is described and applied to evaluate the urinary clearance of antibody-based drugs labeled with the stable isotope of yttrium, 89Y. This approach overcomes some important limitations for pre-clinical radioanalytical methods such as radiation hazards and radioactive waste disposal. Method development was performed by determining detection and quantification limits, and precision as repeatability and trueness. These performance parameters fulfilled the acceptance criteria for bioanalytical methods.
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U2 - 10.1002/rcm.3094
DO - 10.1002/rcm.3094
M3 - Article
C2 - 17590870
AN - SCOPUS:34547171637
VL - 21
SP - 2343
EP - 2350
JO - Rapid Communications in Mass Spectrometry
JF - Rapid Communications in Mass Spectrometry
SN - 0951-4198
IS - 14
ER -