Validation of a flow cytometry based binding assay for evaluation of monoclonal antibody recognizing EGF receptor

Scientia Pharmaceutica

Volumn 79, Issue 3, 2011, Pages 569-581

  Cedeño Arias, Mercedes ^a   Sánchez Ramírez, Javier ^a   Blanco Santana, Rancés ^a   Rengifo Calzado, Enrique ^a  

^a CENTER OF MOLECULAR IMMUNOLOGY   (Cuba)

Author keywords

Binding assays; Method validation; Monoclonal antibody; Nimotuzumab

Indexed keywords

EPIDERMAL GROWTH FACTOR RECEPTOR; NIMOTUZUMAB; PARAFORMALDEHYDE;

ACCURACY; ARTICLE; BINDING ASSAY; CELL SURFACE; CONCENTRATION RESPONSE; CONTROLLED STUDY; DEGRADATION KINETICS; DRUG RECEPTOR BINDING; DRUG STABILITY; EVALUATION; FLOW CYTOMETRY; GENE OVEREXPRESSION; HUMAN; HUMAN CELL; MOLECULAR RECOGNITION; REPRODUCIBILITY; VALIDATION PROCESS; VALIDATION STUDY;

EID: 80051732992     PISSN: 00368709     EISSN: 22180532     Source Type: Journal    
DOI: 10.3797/scipharm.1104-18     Document Type: Article

References (17)

1. Mire-Sluis AR. Progress in the use of biological assay during the development of biotechnology products. Pharm Res. 2001; 18: 1239-1246. doi:10.1023/A:1013067424248
2. International conference on the harmonization (ICH). Specifications: test procedures and acceptance criteria for biotechnological/biological products. Q6B 1999.
3. International conference on the harmonization (ICH). Validation of analytical procedures, Q2 (R1): Text and Methodology. Step 4, 2005.
4. Food and Drug Administration (FDA). Guidance for Industry. Bioanalytical Method Validation 2001, pp. 2-4.
5. Mateo C, Moreno E, Amour K, Lombardero J, Harris W, Perez R. Humanization of a mouse monoclonal antibody that blocks the epidermal growth factor receptor: recovery of antagonistic activity. Immunotechnology. 1997; 3: 71-81. doi:10.1016/S1380-2933(97)00065-1
6. Talavera A, Friemann R, Gomez-Puerta S, Martínez-Fleites C, Garrido G, Rabasa A, López-Requena A, Pupo A, Johansen RF, Sanchez O, Krengel U, Moreno E. Nimotuzumab, an antitumor antibody that targets the epidermal growth factor receptor, blocks ligand binding while permitting the active receptor conformation. Cancer Res. 2009; 69: 5851-5859. doi:10.1158/0008-5472.CAN-08-4518
7. Gupta S, Indelicato SR, Jethwa V, Kawabata T, Kelley M, Mire-Sluis AR, Richards SM, Rup B, Shores E, Swanson SJ, Wakshull E. Recommendations for the design optimization, and qualification of cell-based assays used for the detection of neutralizing antibody responses elicited to biological therapeutics. J Immunol Methods. 2007; 321: 1-18. doi:10.1016/j.jim.2006.12.004
8. Findlay JWA, Smith WC, Lee JW, Nordblom GD, Das I, DeSilva BS, Khan MN, Bowsher RR. Validation of immunoassays for bioanalysis: a pharmaceutical industry perspective. J Pharm Biomed Anal. 2000; 21: 1249-1273. doi:10.1016/S0731-7085(99)00244-7
9. Wyant T, Lackey A, Green M. Validation of a flow cytometry based chemokine internalization assay for use in evaluating the pharmacodynamic response to a receptor antagonist. J Transl Med. 2008; 6: 76. doi:10.1186/1479-5876-6-76
10. Ermer J. Validation in pharmaceutical analysis. Part I: An integrated approach. J Pharm Biomed Anal. 2001; 24: 755-767. doi:10.1016/S0731-7085(00)00530-6
11. Chatelier RC, Ashcroft RG, Lloyd CJ, Nice EC, Whitehead RH, Sawyer WH, Burgess AW. Binding of fluoresceinated epidermal growth factor to A431 cell sub-populations studied using a model-independent analysis of flow cytometric fluorescence data. EMBO J. 1986; 5: 1181-1186. PMid:3015587
12. Suarez-Pestana E, Greiser U, Sanchez B, Fernandez LE, Lage A, Perez R, Bohmer F-D. Growth inhibition of human lung adenocarcinoma cells by antibodies against epidermal growth factor receptor and by ganglioside GM3: involvement of receptordirected protein tyrosine phosphatase(s). Br J Cancer. 1997; 75: 213-220. doi:10.1038/bjc.1997.36
13. Vander H, Nijhuis A, Smeyers-Verbeke J, Vandeginste BGM, Massart DL. Guidance for robustness/ruggedness test in methods validation. J Pharm Biomed Anal. 2001; 24: 723-753. doi:10.1016/S0731-7085(00)00529-X
14. Maes ML, Davidson L, McDonagh PF, Ritter LS. Comparison of Sample Fixation and the use of LDS-751 or anti-CD45 for Leukocyte Identification in Mouse Whole Blood for Flow Cytometry. J Immunol Methods. 2007; 319: 79-86. doi:10.1016/j.jim.2006.10.016
15. Kelley M, De Silva B. Key Elements of Bioanalytical Method Validation for Macromolecules. AAPS J. 2007; 9: E156-E163. doi:10.1208/aapsj0902017
16. Chaloner G, Anderson R, Fonseca MA, Gómez JF. A WHO guide to good manufacturing practice (GMP) requirements. World Health Organization. 1997, pp. 65-67.
17. Roederer M. Conjugation of monoclonal antibodies. http://www.drmr.com/abcon/