Development and validation of an enzyme-linked immunosorbent assay for the quantification of trastuzumab in human serum and plasma

Analytical Biochemistry

Volumn 391, Issue 2, 2009, Pages 114-120

  Damen, Carola W N ^a,b,c   de Groot, Els R ^b   Heij, Marianne ^c   Boss, David S ^a   Schellens, Jan H M ^a,d   Rosing, Hilde ^a   Beijnen, Jos H ^a,d   Aarden, Lucien A ^b  

^a NETHERLANDS CANCER INSTITUTE   (Netherlands)

^b SANQUIN RESEARCH   (Netherlands)

^c Sanquin Diagnostiek   (Netherlands)

^d Division of Biomedical Analysis   (Netherlands)

Author keywords

Anti idiotype; ELISA; Herceptin; Trastuzumab

Indexed keywords

ENZYMES; PATIENT TREATMENT; PHARMACOKINETICS;

ELISA; ENZYME LINKED IMMUNOSORBENT ASSAY; HERCEPTIN; HORSE-RADISH PEROXIDASE; HUMANIZED MONOCLONAL ANTIBODY; IDIOTYPE; PHARMACOKINETIC STUDIES; TRASTUZUMAB;

MONOCLONAL ANTIBODIES;

ANTIIDIOTYPIC ANTIBODY; TRASTUZUMAB;

ACCURACY; ANTIBODY PRODUCTION; ARTICLE; BLOOD SAMPLING; CONTROLLED STUDY; DRUG DETERMINATION; ENZYME LINKED IMMUNOSORBENT ASSAY; HUMAN; PRIORITY JOURNAL; REPRODUCIBILITY; SENSITIVITY AND SPECIFICITY; VALIDATION PROCESS;

ARMORACIA RUSTICANA; ORYCTOLAGUS CUNICULUS;

EID: 67449149486     PISSN: 00032697     EISSN: 10960309     Source Type: Journal    
DOI: 10.1016/j.ab.2009.05.030     Document Type: Article

References (16)

1. Carter P., Presta L., Gorman C.M., Ridgway J.B., Henner D., Wong W.L., Rowland A.M., Kotts C., Carver M.E., and Shepard H.M. Humanization of an anti-p185HER2 antibody for human cancer therapy. Proc. Natl. Acad. Sci. USA 89 (1992) 4285-4289
2. Hudis C.A. Trastuzumab: mechanism of action and use in clinical practice. N. Engl. J. Med. 357 (2007) 39-51
3. Jahanzeb M. Adjuvant trastuzumab therapy for HER2-positive breast cancer. Clin. Breast Cancer 8 (2008) 324-333
4. Leveque D., Gigou L., and Bergerat J.P. Clinical pharmacology of trastuzumab. Curr. Clin. Pharmacol. 3 (2008) 51-55
5. Baselga J., Tripathy D., Mendelsohn J., Baughman S., Benz C.C., Dantis L., Sklarin N.T., Seidman A.D., Hudis C.A., Moore J., Rosen P.P., Twaddell T., Henderson I.C., and Norton L. Phase II study of weekly intravenous trastuzumab (Herceptin) in patients with HER2/neu-overexpressing metastatic breast cancer. Semin. Oncol. 26 (1999) 78-83
6. Pegram M.D., Hsu S., Lewis G., Pietras R., Beryt M., Sliwkowski M., Coombs D., Baly D., Kabbinavar F., and Slamon D. Inhibitory effects of combinations of HER-2/neu antibody and chemotherapeutic agents used for treatment of human breast cancers. Oncogene 18 (1999) 2241-2251
7. Leyland-Jones B., Gelmon K., Ayoub J.P., Arnold A., Verma S., Dias R., and Ghahramani P. Pharmacokinetics, safety, and efficacy of trastuzumab administered every three weeks in combination with paclitaxel. J. Clin. Oncol. 21 (2003) 3965-3971
8. Baselga J., Carbonell X., Castaneda-Soto N.J., Clemens M., Green M., Harvey V., Morales S., Barton C., and Ghahramani P. Phase II study of efficacy, safety, and pharmacokinetics of trastuzumab monotherapy administered on a 3-weekly schedule. J. Clin. Oncol. 23 (2005) 2162-2171
9. Bruno R., Washington C.B., Lu J.F., Lieberman G., Banken L., and Klein P. Population pharmacokinetics of trastuzumab in patients with HER2+ metastatic breast cancer. Cancer Chemother. Pharmacol. 56 (2005) 361-369
10. Maple L., Lathrop R., Bozich S., Harman W., Tacey R., Kelley M., and Danilkovitch-Miagkova A. Development and validation of ELISA for Herceptin detection in human serum. J. Immunol. Methods 295 (2004) 169-182
11. U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Guidance for Industry: Bioanalytical Method Validation, 2001. Available from: .
12. Kelley M., and DeSilva B. Key elements of bioanalytical method validation for macromolecules. AAPS J. 9 (2007) E156-E163
13. Viswanathan C.T., Bansal S., Booth B., DeStefano A.J., Rose M.J., Sailstad J., Shah V.P., Skelly J.P., Swann P.G., and Weiner R. Quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays. Pharm. Res. 24 (2007) 1962-1973
14. DeSilva B., Smith W., Weiner R., Kelley M., Smolec J., Lee B., Khan M., Tacey R., Hill H., and Celniker A. Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules. Pharm. Res. 20 (2003) 1885-1900
15. Sasso E.H., Silverman G.J., and Mannik M. Human IgA and IgG F(ab′)2 that bind to staphylococcal protein A belong to the VHIII subgroup. J. Immunol. 147 (1991) 1877-1883
16. Kricka L.J. Human anti-animal antibody interferences in immunological assays. Clin. Chem. 45 (1999) 942-956