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Volumn 11, Issue 1, 2009, Pages 133-138

Antidrug antibody assay validation: Industry survey results

Author keywords

Antidrug antibody; Antiproduct antibody; Biopharmaceutics; Immunogenicity

Indexed keywords

DRUG; DRUG ANTIBODY;

EID: 65549156596     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/s12248-009-9091-6     Document Type: Conference Paper
Times cited : (27)

References (18)
  • 3
    • 33645540499 scopus 로고    scopus 로고
    • Understanding and applying regulatory guidance on the nonclinical development of biotechnology-derived pharmaceuticals
    • D. J. Snodin, and P. R. Ryle. Understanding and applying regulatory guidance on the nonclinical development of biotechnology-derived pharmaceuticals. Biodrugs. 20(1):25-52 (2006).
    • (2006) Biodrugs , vol.20 , Issue.1 , pp. 25-52
    • Snodin, D.J.1    Ryle, P.R.2
  • 4
    • 0036890997 scopus 로고    scopus 로고
    • Immune responses to therapeutic proteins in humans-clinical significance, assessment and prediction
    • E. Koren, L. A. Zuckerman, and A. R. Mire-Sluis. Immune responses to therapeutic proteins in humans-clinical significance, assessment and prediction. Curr. Pharm. Biotechnol. 3:349-360 (2002).
    • (2002) Curr. Pharm. Biotechnol. , vol.3 , pp. 349-360
    • Koren, E.1    Zuckerman, L.A.2    Mire-Sluis, A.R.3
  • 5
    • 9644287732 scopus 로고    scopus 로고
    • A risk-based approach to immunogenicity concerns of therapeutic protein products, part 1: Considering consequences of the immune response to a protein
    • A. S. Rosenberg, and A. Worobec. A risk-based approach to immunogenicity concerns of therapeutic protein products, part 1: Considering consequences of the immune response to a protein. BioPharm. Int. 17:22-26 (2004).
    • (2004) BioPharm. Int. , vol.17 , pp. 22-26
    • Rosenberg, A.S.1    Worobec, A.2
  • 6
    • 10944231251 scopus 로고    scopus 로고
    • A risk-based approach to immunogenicity concerns of therapeutic protein products, part 2: Considering host-specific and product-specific factors impacting immunogenicity
    • A. S. Rosenberg, and A. Worobec. A risk-based approach to immunogenicity concerns of therapeutic protein products, part 2: Considering host-specific and product-specific factors impacting immunogenicity. BioPharm. Int. 17:34-42 (2004).
    • (2004) BioPharm. Int. , vol.17 , pp. 34-42
    • Rosenberg, A.S.1    Worobec, A.2
  • 8
    • 33644618536 scopus 로고    scopus 로고
    • Characterization of an immune response
    • S. J. Swanson. Characterization of an immune response. Dev. Biol (Basel). 122:95-101 (2005).
    • (2005) Dev. Biol (Basel) , vol.122 , pp. 95-101
    • Swanson, S.J.1
  • 9
    • 33747584697 scopus 로고    scopus 로고
    • Strategies and assays for the assessment of unwanted immunogenicity
    • M. Wadhwa, and R. Thorpe. Strategies and assays for the assessment of unwanted immunogenicity. J. Immunotoxicol. 3(3):115-121 (2006).
    • (2006) J. Immunotoxicol. , vol.3 , Issue.3 , pp. 115-121
    • Wadhwa, M.1    Thorpe, R.2
  • 12
    • 34249684926 scopus 로고    scopus 로고
    • A risk-based bioanalytical for the assessment of antibody immune responses against biological drugs
    • G. Shankar, C. Pendley, and K. E. Stein. A risk-based bioanalytical for the assessment of antibody immune responses against biological drugs. Nat. Biotechnol. 25:555-561 (2007).
    • (2007) Nat. Biotechnol. , vol.25 , pp. 555-561
    • Shankar, G.1    Pendley, C.2    Stein, K.E.3
  • 13
    • 33744950980 scopus 로고    scopus 로고
    • Scientific and regulatory considerations on the immunogenicity of biologics
    • G. Shankar, E. Shores, C. Wagner, and A. R. Mire-Sluis. Scientific and regulatory considerations on the immunogenicity of biologics. Trends Biotechnol. 24(6):274-280 (2006).
    • (2006) Trends Biotechnol. , vol.24 , Issue.6 , pp. 274-280
    • Shankar, G.1    Shores, E.2    Wagner, C.3    Mire-Sluis, A.R.4
  • 17
    • 24344448252 scopus 로고    scopus 로고
    • An acid dissociation bridging ELISA for detection of antibodies directed against therapeutic proteins in the presence of antigen
    • A. Patton, M. C. Mullenix, S. J. Swanson, and E. Koren. An acid dissociation bridging ELISA for detection of antibodies directed against therapeutic proteins in the presence of antigen. J. Immunol. Methods. 304:189-195 (2005).
    • (2005) J. Immunol. Methods. , vol.304 , pp. 189-195
    • Patton, A.1    Mullenix, M.C.2    Swanson, S.J.3    Koren, E.4
  • 18
    • 30844473493 scopus 로고    scopus 로고
    • Detection of neutralizing anti-therapeutic protein antibodies in serum or plasma samples containing high levels of the therapeutic protein
    • J. A. Lofgren, I. Wala, E. Koren, S. J. Swanson, and S. Jing. Detection of neutralizing anti-therapeutic protein antibodies in serum or plasma samples containing high levels of the therapeutic protein. J. Immunol. Methods. 308:101-108 (2006).
    • (2006) J. Immunol. Methods. , vol.308 , pp. 101-108
    • Lofgren, J.A.1    Wala, I.2    Koren, E.3    Swanson, S.J.4    Jing, S.5


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.