Cut Points and Performance Characteristics for Anti-Drug Antibody Assays

Detection and Quantification of Antibodies to Biopharmaceuticals: Practical and Applied Considerations

Volumn , Issue , 2011, Pages 287-308

  Devanarayan, Viswanath ^a   Tovey, Michael G ^b  

^a Abbott Laboratories Inc   (United States)

^b Ecole Normale Superieure de Cachan   (France)

Author keywords

Confirmatory cut point, positive samples screening assay, ADA levels specific to study drug; Minimum required dilution (MRD) determined, prior to validation experiments; Statistical, cut points and performance characteristics for anti drug antibody assays

Indexed keywords

EID: 84871769050     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9781118075685.ch16     Document Type: Chapter

References (8)

1. Casadevall, N., Nataf, J., Viron, B., Kolta, A., Kiladjian, J.J., Martin-Dupont, P., Michaud, P., Papo, T., Ugo, V., Teyssandier, I., Varet, B., Mayeux, P. ( 2002 ). Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin . N Engl J Med, 346, 469-475 .
2. Li, J., Yang, C., Xia, Y., Bertino, A., Glaspy, J., Roberts, M., Kuter, D.J. ( 2001 ). Thrombocytopenia caused by the development of antibodies to thrombopoietin . Blood, 98, 3241-3248 .
3. 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. ( 2004 ). Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products . J Immunol Methods, 289, 1-16 .
4. Koren, E., Smith, H.W., Shores, E., Shankar, G., Finco-Kent, D., Rup, B., Barett, Y.C., Devanarayan, V., Gorovits, B., Gupta, S., Parish, T., Quarmby, V., Moxness, M., Swanson, S.J., Taniguchi, G., Zuckerman, L.S., Stebbins, C.C., and Mire-Sluis, A. ( 2008 ). Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products . J Immunol Methods, 333, 1-9 .
5. Shankar, G., Devanarayan, V., Barrett, Y.C., Bowsher, R., Finco-Kent, D., Fiscella, M., Gorovits, B., Kirschner, S., Moxness, M., Parish, T., Quarmby, V., Shores, E., Smith, H., Smith, W., Zhong, J., Zuckerman, L., Koren, E. ( 2008 ). Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products . J Pharm Biomed Anal, 48, 1267-1281 .
6. Gupta, S., Indelicato, S.R., Jethwa, V., Kawabata, T., Kelley, M., Mire-Sluis, A.R., Richards, S.M., Rup, B., Shores, E., Swanson, S.J., Wakshull, E. ( 2007 ). 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, 321, 1-18 .
7. Gupta, S., Devanarayan, V., Finco, D., Gunn, G., Kirshner, S., Richards, S., Rup, B., Song, A., Subramanyam, M. ( 2011 ). Recommendations for the validation of cell-based assays used for the detection of neutralizing antibody immune responses elicited against biological therapeutics, to appear in J Pharm Biomed Anal .
8. Parish, T., Finco, D., Devanarayan, V. ( 2010 ). Development and validation of immunogenicity assays for preclinical and clinical studies . In Ligand-Binding Assays . Findlay J, Khan M, eds. Wiley, Hoboken, NJ, chap. 8 .