Qualification and application of a surface plasmon resonance-based assay for monitoring potential HAHA responses induced after passive administration of a humanized anti Lewis-Y antibody

Journal of Pharmaceutical and Biomedical Analysis

Volumn 41, Issue 4, 2006, Pages 1347-1353

  Szolar, O H J ^a   Stranner, S ^b   Zinoecker, I ^b   Mudde, G C ^b   Himmler, G ^b   Waxenecker, G ^b   Nechansky, A ^b  

^a Onepharm   (Austria)

^b Immunotherapy of Cancer ^*  (Austria)

Author keywords

BIACORE; HAHA; Lewis Y; Qualification

Indexed keywords

DEXTRAN; IMMUNOGLOBULIN ANTIBODY; IMMUNOGLOBULIN G; MONOCLONAL ANTIBODY; MONOCLONAL ANTIBODY IGN 311; UNCLASSIFIED DRUG;

ANTIBODY RESPONSE; ANTIBODY SPECIFICITY; ANTIGEN ANTIBODY REACTION; ARTICLE; BLOOD SAMPLING; CONTROLLED STUDY; HUMAN; HUMAN EXPERIMENT; NORMAL HUMAN; PATIENT SAFETY; PRIORITY JOURNAL; PROTEIN BINDING; SURFACE PLASMON RESONANCE;

ANALYSIS OF VARIANCE; ANTIBODIES, ANTI-IDIOTYPIC; ANTIBODIES, MONOCLONAL; ANTIBODY AFFINITY; CALIBRATION; CLINICAL TRIALS, PHASE I; DRUG MONITORING; HUMANS; IMMUNIZATION, PASSIVE; LEWIS BLOOD-GROUP SYSTEM; SENSITIVITY AND SPECIFICITY; SURFACE PLASMON RESONANCE;

EID: 33646910169     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2006.03.026     Document Type: Article

References (19)

1. US Department of Health and Social Services. Food and Drug Administration, 1997, Docket no. 94D-0259.
2. Wieden P.L., Wolf S.B., Breitz H.B., Appelbaum J.W., Seiler C.A., and Mallet R. Cancer 73 (1994) 1093-1097
3. Becker W., Goldenberg D.M., and Wolf F. Semin. Nucl. Med. 24 (1994) 142-153
4. Cobleigh M.A., Vogel C.L., Tripathy D., Robert N.J., Scholl S., Fehrenbacher L., Wolter J.M., Paton V., Shak S., Lieberman G., and Slamon D.J. J. Clin. Oncol. 17 (1999) 2639-2648
5. Gordon M.S., Margolin K., Talpaz M., Sledge Jr. G.W., Holmgren E., Benjamin R., Stalter S., Shak S., and Adelman D. J. Clin. Oncol. 19 (2001) 843-850
6. Hale G., Rebello P., Brettman L.R., Fegan C., Kennedy B., Kimby E., Leach M., Lundin J., Mellstedt H., Moreton P., Rawstron A.C., Waldmann H., Osterborg A., and Hillmen P. Blood 104 (2004) 948-955
7. Welt S., Ritter G., Willimans Jr. C., Cohen S.S., John M., Jungbluth A., Richards E.A., Old L.J., and Kemeny N.E. Clin. Cancer Res. 9 (2003) 1338-1346
8. Gonzales N.R., Schuck P., Schlom J., and Kashmiri S.V.S. J. Immunol. Methods 268 (2002) 197-210
9. McDonnell J.M. Curr. Opin. Chem. Biol. 5 (2001) 572-577
10. Roovers R.C., van der Linden E., Bruine A.P., Arends J.R., and Hoogenboom H.R. Cancer Immunol. Immunother. 50 (2001) 51-59
11. Carnahan J., Wang P., Kendall R., Chen C., Hu S., Boone T., Juan T., Talvenheimo J., Montestruque S., Sun J., Elliott G., Thomas J., Ferbas J., Kern B., Briddell R., Leonhard J.P., and Cesano A. Clin. Cancer Res. 9 (2003) 2982S-3990S
12. Imakiire T., Kuroki M., Shibaguchi H., Abe H., Yamauchi Y., Ueno A., Hirose Y., Yamada H., Yamashita Y., Shirakusa T., and Ishida I. Int. J. Chancer 108 (2004) 564-570
13. Ezekiel R.F., Spencer M.P., Meredith S.A., Bonner R.F., Khazaeli J.A., Saleh M.B., Carey M.N., LoBuglio D., Wheeler A.F., Cooper R.H., and Waksal M.R. J. Clin. Oncol. 19 (2001) 3234-3243
14. Ritter G., Cohen L.S., Williams Jr. C., Richards E.C., Old L.J., and Welt S. Cancer Res. 61 (2001) 6851-6859
15. Mason S., La S., Mytych D., Swanson S.J., and Ferbas J. Curr. Med. Res. Opin. 19 (2003) 651-659
16. Shah V.P., Midha K.K., Dighe S., McGilveray I.J., Skelly J.P., Yacobi A., Layoff T., Viswanathan C.T., Cook C.E., McDowall R.D., Pittman K.A., and Spector S. Pharm. Res. 9 (1992) 588-592
17. Findlay J.W.A., Smith W.C., Lee J.W., Nordblom G.D., Das I., DeSilva B.S., Khan M.N., and Bowsher R.R. J. Pharm. Biomed. Anal. 21 (2000) 1249-1273
18. DeSilva B., Smith W., Weiner R., Kelley M., Smolec J., Lee B., Khan M., Tacey R., Hill H., and Celniker A. Pharm. Res. 20 (2003) 1885-1900
19. Wong R.L., Mytych D., Jacobs S., Bordens R., and Swanson S.J. J. Immunol. Methods 209 (1997) 1-15