Development and optimization of a cell-based neutralizing antibody assay using a sample pre-treatment step to eliminate serum interference

Journal of Immunological Methods

Volumn 358, Issue 1-2, 2010, Pages 35-45

  McCutcheon, Krista M ^a   Quarmby, Valerie ^a   Song, An ^a  

^a GENENTECH INC   (United States)

Author keywords

Autoimmune; NAb assay; Neutralizing antibody; Serum pre treatment

Indexed keywords

IMMUNOGLOBULIN G1; NEUTRALIZING ANTIBODY; RESIN; RHEUMATOID FACTOR;

ANIMAL EXPERIMENT; ANTIBODY DETECTION; ANTIBODY RESPONSE; ARTICLE; AUTOIMMUNITY; BLOOD SAMPLING; COMPLEMENT DEPENDENT CYTOTOXICITY; CONCENTRATION RESPONSE; CONTROLLED STUDY; CROSS REACTION; DAUDI CELL; HUMAN; HUMAN CELL; IMMUNOASSAY; MONKEY; NONHUMAN; PRIORITY JOURNAL; PROCESS OPTIMIZATION; PROTEIN PURIFICATION; RHEUMATOID ARTHRITIS; SENSITIVITY AND SPECIFICITY; VALIDATION PROCESS;

ANIMALS; ANTIBODIES, MONOCLONAL; ANTIBODIES, NEUTRALIZING; ARTHRITIS, RHEUMATOID; ARTIFACTS; AUTOIMMUNE DISEASES; CELL LINE, TUMOR; COMPLEMENT PATHWAY, CLASSICAL; CROSS REACTIONS; CYTOTOXICITY TESTS, IMMUNOLOGIC; GOATS; HUMANS; IMMUNOASSAY; IMMUNOGLOBULIN G; MACACA FASCICULARIS; REPRODUCIBILITY OF RESULTS; SERUM;

EID: 77953292661     PISSN: 00221759     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jim.2010.03.016     Document Type: Article

References (10)

1. Carson D.A., Kaye J., Wasson D.B. Differences in deoxyadenosine metabolism in human and mouse lymphocytes. The Journal of Immunology 1980, 124(1):8.
2. Corper A.L., Sohi M.K., Bonagura V.R., Steinitz M., Jefferis R., Feinstein A., Beale D., Taussig M.J., Sutton B.J. Structure of human IgM rheumatoid factor Fab bound to its autoantigen IgG Fc reveals a novel topology of antibody-antigen interaction. Nature Structural & Molecular Biology 1997, 4(5):374.
3. Gazzano-Santoro H., Ralph P., Ryskamp T.C., Chen A.B., Mukku V.R. A non-radioactive complement-dependent cytotoxicity assay for anti-CD20 monoclonal antibody. JIM 1997, 202:163.
4. Grossberg S.E., Kawade Y., Kohase M., Yokoyama H., Finter N. The neutralization of interferons by antibody. I. Quantitative and theoretical analyses of the neutralization reaction in different bioassay systems. Journal of Interferon & Cytokine Research 2001, 21:729.
5. Gupta S., Idelicato S.R., Jetthwa V., Kawabata T., Kelley M., Mire-Sluis A.R., Richards S.M., Rup B., Shores E., Swanson S.J., Wakshull E. Review. Recommendations for the design, optimization, and qualification of cell-based assays used for the detection of neutralizing antibody resonses elicited to biological therapeutics. Journal of Immunological Methods 2007, 321:1.
6. Hu J., Gupta S., Swanson S.J., Zhuang Y. A bioactive drug quantitation based approach for the detection of anti-drug neutralizing antibodies in human serum. Journal of Immunological Methods 2009, 345:70.
7. Idusogie E.E., et al. Mapping of the C1q binding site on rituxan, a chimeric antibody with a human IgG1 Fc. Journal of Immunology 2000, 164(8):4178-4187.
8. McCutcheon K.M., O'Hara E., Fei D. Multiplexed serum measurement of IgG, IgA, IgM and IgE antibody responses to therapeutic biologicals. Immunological Investigations 2005, 34(2):199.
9. Mire-Sluis A.R., Barrett Y.C., Devanarayan V., Koren E., Liu H., Maia M., Parish T., Scott G., Shankar G., Shores E., Swanson S.J., Taniguchi G., Wierda D., Zuckerman L.A. Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products. Journal of Immunological Methods 2004, 289(1-2):1.
10. Shankar G., Devanarayan V., Amaravadi L., Barrett Y.C., Bowsher R., Finco-Kent D., Fiscella M., Gorovits B., Kirschner S., Moxness M., Parish T., Quarmby V., Smith H., Smith W., Zuckerman L.A., Koren E. Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products. Journal of Pharmaceutical and Biomedical Analysis 2008, 48(5):1267.