-
2
-
-
84886025335
-
-
European Medicines Agency, Guideline on similar biological medicinal products
-
European Medicines Agency . ( 2005 ). Guideline on similar biological medicinal products . Available at http://www.EMEA.europa.eu/pdfs/human/biosimilar/043704en.pdf.
-
(2005)
-
-
-
3
-
-
84886004122
-
-
European Medicines Agency, Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues
-
European Medicines Agency . ( 2006 ). Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues . Available at http://www.EMEA.europa.eu/pdfs/human/biosimilar/4934805en.pdf.
-
(2006)
-
-
-
4
-
-
84886019747
-
-
European Medicines Agency, Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues
-
European Medicines Agency . ( 2006 ). Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues . Available at http://www.EMEA.europa.eu/pdfs/human/biosimilar/4283205en.pdf.
-
(2006)
-
-
-
5
-
-
2642526933
-
Neutralizing antibodies to interferon beta: implications for the management of multiple sclerosis
-
Bertolotto, A. ( 2004 ). Neutralizing antibodies to interferon beta: implications for the management of multiple sclerosis . Curr Opin Neurol, 17, 241-246 .
-
(2004)
Curr Opin Neurol
, vol.17
, pp. 241-246
-
-
Bertolotto, A.1
-
6
-
-
69249206732
-
The molecular mechanisms of immunomodulation and tolerance induction to factor VIII
-
Waters, B., Lillicrap, D. ( 2009 ). The molecular mechanisms of immunomodulation and tolerance induction to factor VIII . J Thromb Haemost, 7 ( 9 ), 1446-1456 .
-
(2009)
J Thromb Haemost
, vol.7
, Issue.9
, pp. 1446-1456
-
-
Waters, B.1
Lillicrap, D.2
-
7
-
-
49449090469
-
Neutralizing antibodies to therapeutic enzymes: considerations for testing, prevention and treatment
-
Wang, J., Lozier, J., Johnson, G., Kirshner, S., Verthelyi, D., Pariser, A., Shores, E., Rosenberg, A. ( 2008 ). Neutralizing antibodies to therapeutic enzymes: considerations for testing, prevention and treatment . Nature Biotechnol, 26 ( 8 ), 901-908 .
-
(2008)
Nature Biotechnol
, vol.26
, Issue.8
, pp. 901-908
-
-
Wang, J.1
Lozier, J.2
Johnson, G.3
Kirshner, S.4
Verthelyi, D.5
Pariser, A.6
Shores, E.7
Rosenberg, A.8
-
8
-
-
0037434552
-
Influence of immunogenicity on the long-term efficacy of infliximab in Crohn ' s disease
-
Baert, F., Noman, M., Vermiere, S., Van Assche, G., D'Haens, G., Carbonez, A., Rutgeerts, P. ( 2003 ). Influence of immunogenicity on the long-term efficacy of infliximab in Crohn ' s disease . N Engl J Med, 348, 601-608 .
-
(2003)
N Engl J Med
, vol.348
, pp. 601-608
-
-
Baert, F.1
Noman, M.2
Vermiere, S.3
Van Assche, G.4
D'Haens, G.5
Carbonez, A.6
Rutgeerts, P.7
-
9
-
-
0035760892
-
Thrombocytopenia caused by the development of antibodies to thrombopoietin
-
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 .
-
(2001)
Blood
, vol.98
, pp. 3241-3248
-
-
Li, J.1
Yang, C.2
Xia, Y.3
Bertino, A.4
Glaspy, J.5
Roberts, M.6
Kuter, D.J.7
-
10
-
-
0037075272
-
Pure red cell aplasia and anti-erythropoietin antibodies against human erythropoietin in patients treated with recombinant erythropoietin
-
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 anti-erythropoietin antibodies against human erythropoietin in patients treated with recombinant erythropoietin . N Engl J Med, 346, 469-475 .
-
(2002)
N Engl J Med
, vol.346
, pp. 469-475
-
-
Casadevall, N.1
Nataf, J.2
Viron, B.3
Kolta, A.4
Kiladjian, J.J.5
Martin-Dupont, P.6
Michaud, P.7
Papo, T.8
Ugo, V.9
Teyssandier, I.10
Varet, B.11
Mayeux, P.12
-
11
-
-
84886071027
-
-
European Medicines Agency, Guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins
-
European Medicines Agency . ( 2007 ). Guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins . Available at http://www.EMEA.europa.eu/pdfs/human/biosimilar/1432706en.pdf.
-
(2007)
-
-
-
12
-
-
84886022817
-
-
European Medicines Agency, Concept paper on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use has been released for consultation
-
European Medicines Agency . ( 2009 ). Concept paper on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use has been released for consultation . Available at http://www.EMEA.europa.eu/pdfs/human/biosimilar/11472009en.pdf.
-
(2009)
-
-
-
13
-
-
0345424863
-
-
Food and Drug Administration (FDA), Assay development for immunogenicity testing of therapeutic proteins
-
Food and Drug Administration (FDA) . ( 2009 ). Guidance for industry. Assay development for immunogenicity testing of therapeutic proteins . Available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM192750.pdf.
-
(2009)
Guidance for industry
-
-
-
14
-
-
3142534409
-
Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products
-
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 .
-
(2004)
J Immunol Methods
, vol.289
, pp. 1-16
-
-
Mire-Sluis, A.R.1
Barrett, Y.C.2
Devanarayan, V.3
Koren, E.4
Liu, H.5
Maia, M.6
Parish, T.7
Scott, G.8
Shankar, G.9
Shores, E.10
Swanson, S.J.11
Taniguchi, G.12
Wierda, D.13
Zuckerman, L.A.14
-
15
-
-
33947397632
-
Recommendations for the design, optimization, and qualification of cell-based assays used for the detection of neutralizing antibody responses elicited to biological therapeutics
-
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 .
-
(2007)
J Immunol Methods
, vol.321
, pp. 1-18
-
-
Gupta, S.1
Indelicato, S.R.2
Jethwa, V.3
Kawabata, T.4
Kelley, M.5
Mire-Sluis, A.R.6
Richards, S.M.7
Rup, B.8
Shores, E.9
Swanson, S.J.10
Wakshull, E.11
-
16
-
-
58249116651
-
Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products
-
Shankar, G., Devanarayan, V., Amaravadi, L., et al. ( 2008 ). Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products . J Pharm Biomed Anal, 48 ( 5 ), 1267-1281 .
-
(2008)
J Pharm Biomed Anal
, vol.48
, Issue.5
, pp. 1267-1281
-
-
Shankar, G.1
Devanarayan, V.2
Amaravadi, L.3
-
17
-
-
41349116947
-
Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products
-
Koren, E., Smith, H.W., Shores, E., Shankar, G., Finco-Kent, D., Rup, B., Barrett, Y.C., Devanarayan, V., Gorovits, B., Gupta, S., Parish, T., Quarmby, V., Moxness, M., Swanson, S.J., Taniguchi, G., Zuckerman, L.A., Stebbins, C.C., Mire-Sluis, A. ( 2008 ). Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products . J Immunol Methods, 333 ( 1-2 ), 1-9 .
-
(2008)
J Immunol Methods
, vol.333
, Issue.1-2
, pp. 1-9
-
-
Koren, E.1
Smith, H.W.2
Shores, E.3
Shankar, G.4
Finco-Kent, D.5
Rup, B.6
Barrett, Y.C.7
Devanarayan, V.8
Gorovits, B.9
Gupta, S.10
Parish, T.11
Quarmby, V.12
Moxness, M.13
Swanson, S.J.14
Taniguchi, G.15
Zuckerman, L.A.16
Stebbins, C.C.17
Mire-Sluis, A.18
-
18
-
-
34447515607
-
Maintenance therapy with certolizumab pegol for Crohn ' s disease
-
Schreiber, S., Khaliq-Kareemi, M., Lawrance, I.C., Thomsen, O.ø., Hanauer, S.B., McColm, J., Bloomfield, R., Sandborn, W.J. ( 2007 ). Maintenance therapy with certolizumab pegol for Crohn ' s disease . N Engl J Med, 357, 239-250 .
-
(2007)
N Engl J Med
, vol.357
, pp. 239-250
-
-
Schreiber, S.1
Khaliq-Kareemi, M.2
Lawrance, I.C.3
Thomsen, O.ø.4
Hanauer, S.B.5
McColm, J.6
Bloomfield, R.7
Sandborn, W.J.8
-
19
-
-
33847732132
-
Immunogenicity screening in protein drug development
-
Van Walle, I., Gansemans, Y., Parren, P.W., Stas, P., Lasters, I. ( 2007 ). Immunogenicity screening in protein drug development . Expert Opin Biol Ther, 7, 405-418 .
-
(2007)
Expert Opin Biol Ther
, vol.7
, pp. 405-418
-
-
Van Walle, I.1
Gansemans, Y.2
Parren, P.W.3
Stas, P.4
Lasters, I.5
-
20
-
-
84886078847
-
-
European Medicines Agency, European public assessment report (EPAR) for Remicade ®
-
European Medicines Agency . ( 2008 ). European public assessment report (EPAR) for Remicade ® . Available at http://www.EMEA.europa.eu/humandocs/Humans/EPAR/remicade/remicade.htm.
-
(2008)
-
-
-
21
-
-
29244462955
-
Structural characterization and immunogenicity in wild-type and immune tolerant mice of degraded recombinant human interferon alpha2b
-
Hermeling, S., Aranha, L., Damen, J., Slijper, M., Schellekens, H., Crommelin, D., Jiskoot, W. ( 2005 ). Structural characterization and immunogenicity in wild-type and immune tolerant mice of degraded recombinant human interferon alpha2b . Pharm Res, 22, 1997-2006 .
-
(2005)
Pharm Res
, vol.22
, pp. 1997-2006
-
-
Hermeling, S.1
Aranha, L.2
Damen, J.3
Slijper, M.4
Schellekens, H.5
Crommelin, D.6
Jiskoot, W.7
-
22
-
-
71749100389
-
Hybrid transgenic immune tolerant mouse model for assessing the breaking of B cell tolerance by human interferon beta
-
van Beers, M.M., Sauerborn, M., Gilli, F., Hermeling, S., Brinks, V., Schellekens, H., Jiskoot, W. ( 2010 ). Hybrid transgenic immune tolerant mouse model for assessing the breaking of B cell tolerance by human interferon beta . J Immunol Methods, 352 ( 1-2 ), 32-37 .
-
(2010)
J Immunol Methods
, vol.352
, Issue.1-2
, pp. 32-37
-
-
van Beers, M.M.1
Sauerborn, M.2
Gilli, F.3
Hermeling, S.4
Brinks, V.5
Schellekens, H.6
Jiskoot, W.7
-
23
-
-
54049088585
-
Activation of natural regulatory T cells by IgG Fc-derived peptide " Tregitopes "
-
De Groot, A.S., Moise, L., McMurry, J.A., Wambre, E., Van Overtvelt, L., Moingeon, P., Scott, D.W., Martin, W. ( 2008 ). Activation of natural regulatory T cells by IgG Fc-derived peptide " Tregitopes . " Blood, 112 ( 8 ), 3303-3311 .
-
(2008)
Blood
, vol.112
, Issue.8
, pp. 3303-3311
-
-
De Groot, A.S.1
Moise, L.2
McMurry, J.A.3
Wambre, E.4
Van Overtvelt, L.5
Moingeon, P.6
Scott, D.W.7
Martin, W.8
-
24
-
-
34249684926
-
A risk-based bioanalytical strategy for the assessment of antibody immune responses against biological drugs
-
Shankar, G., Pendley, C., Stein, K.E. ( 2007 ). A risk-based bioanalytical strategy for the assessment of antibody immune responses against biological drugs . Nature Biotechnol, 25, 555-561 .
-
(2007)
Nature Biotechnol
, vol.25
, pp. 555-561
-
-
Shankar, G.1
Pendley, C.2
Stein, K.E.3
-
25
-
-
33745685141
-
Detection of anti-EPO antibodies in human sera by a bridging ELISA is much more sensitive when coating biotinylated rhEPO to streptavidin rather than using direct coating of rhEPO
-
Gross, J., Moller, R., Henke, W., Hoesel, W. ( 2006 ). Detection of anti-EPO antibodies in human sera by a bridging ELISA is much more sensitive when coating biotinylated rhEPO to streptavidin rather than using direct coating of rhEPO . J Immunol Methods, 313, 176-182 .
-
(2006)
J Immunol Methods
, vol.313
, pp. 176-182
-
-
Gross, J.1
Moller, R.2
Henke, W.3
Hoesel, W.4
-
26
-
-
0345059073
-
The detection of anti-erythropoietin antibodies in human serum and plasma. Part I. Validation of the protocol for a radioimmunoprecipitation assay
-
Tacey, R., Greway, A., Smiell, J., Power, D., Kromminga, A., Daha, M., Casadevall, N., Kelley, M. ( 2003 ). The detection of anti-erythropoietin antibodies in human serum and plasma. Part I. Validation of the protocol for a radioimmunoprecipitation assay . J Immunol Methods, 283, 317-329 .
-
(2003)
J Immunol Methods
, vol.283
, pp. 317-329
-
-
Tacey, R.1
Greway, A.2
Smiell, J.3
Power, D.4
Kromminga, A.5
Daha, M.6
Casadevall, N.7
Kelley, M.8
-
27
-
-
12744273875
-
Current methods for detecting antibodies against erythropoietin and other recombinant proteins
-
Thorpe, R., Swanson, S.J. ( 2005 ). Current methods for detecting antibodies against erythropoietin and other recombinant proteins . Clin Diagn Lab Immunol, 12, 28-39 .
-
(2005)
Clin Diagn Lab Immunol
, vol.12
, pp. 28-39
-
-
Thorpe, R.1
Swanson, S.J.2
-
28
-
-
25444453709
-
Immunogenicity testing by electrochemiluminescent detection for antibodies directed against therapeutic human monoclonal antibodies
-
Moxness, M., Tatarewicz, S., Weeraratne, D., Murakami, N., Wullner, D., Mytych, D., Jawa, V., Koren, E., Swanson, S.J. ( 2005 ). Immunogenicity testing by electrochemiluminescent detection for antibodies directed against therapeutic human monoclonal antibodies . Clin Chem, 51, 1983-1985 .
-
(2005)
Clin Chem
, vol.51
, pp. 1983-1985
-
-
Moxness, M.1
Tatarewicz, S.2
Weeraratne, D.3
Murakami, N.4
Wullner, D.5
Mytych, D.6
Jawa, V.7
Koren, E.8
Swanson, S.J.9
-
29
-
-
33747584697
-
Strategies and assays for the assessment of unwanted immunogenicity
-
Wadhwa, M., Thorpe, R. ( 2006 ). Strategies and assays for the assessment of unwanted immunogenicity . J Immunotoxicol, 3, 115-121 .
-
(2006)
J Immunotoxicol
, vol.3
, pp. 115-121
-
-
Wadhwa, M.1
Thorpe, R.2
-
30
-
-
48549102501
-
Immunogenicity of anti-tumor necrosis factor antibodies - toward improved methods of anti-antibody measurement
-
Aarden, L., Ruuls, S.R., Wolbink, G. ( 2008 ). Immunogenicity of anti-tumor necrosis factor antibodies - toward improved methods of anti-antibody measurement . Curr Opin Immunol, 20 ( 4 ), 431-435 .
-
(2008)
Curr Opin Immunol
, vol.20
, Issue.4
, pp. 431-435
-
-
Aarden, L.1
Ruuls, S.R.2
Wolbink, G.3
-
31
-
-
34347267600
-
Clinical response to adalimumab: relationship to anti-adalimumab antibodies and serum adalimumab concentrations in rheumatoid arthritis
-
Bartelds, G.M., Wijbrandts, C.A., Nurmohamed, M.T., Stapel, S., Lems, W.F., Aarden, L., Dijkmans, B.A.C., Tak, P.P., Wolbink, G.J. ( 2007 ). Clinical response to adalimumab: relationship to anti-adalimumab antibodies and serum adalimumab concentrations in rheumatoid arthritis . Ann Rheum Dis, 66, 921-926 .
-
(2007)
Ann Rheum Dis
, vol.66
, pp. 921-926
-
-
Bartelds, G.M.1
Wijbrandts, C.A.2
Nurmohamed, M.T.3
Stapel, S.4
Lems, W.F.5
Aarden, L.6
Dijkmans, B.A.C.7
Tak, P.P.8
Wolbink, G.J.9
-
32
-
-
34249814900
-
Comparing ELISA and surface plasmon resonance for assessing clinical immunogenicity of panitumumab
-
Lofgren, J.A., Dhandapani, S., Pennucci, J.J., Abbott . C.M., Mytych, D.T., Kaliyaperumal, A., Swanson, S.J., Mullenix, M.C. ( 2007 ). Comparing ELISA and surface plasmon resonance for assessing clinical immunogenicity of panitumumab . J Immunol, 178, 7467-7772 .
-
(2007)
J Immunol
, vol.178
, pp. 7467-7772
-
-
Lofgren, J.A.1
Dhandapani, S.2
Pennucci, J.J.3
Abbott, C.M.4
Mytych, D.T.5
Kaliyaperumal, A.6
Swanson, S.J.7
Mullenix, M.C.8
-
33
-
-
0033052121
-
Immunogenicity of granulocyte-macrophage colony stimulating factor (GM-CSF) products in patients undergoing combination therapy with GM-CSF
-
Wadhwa, M., Skog, A.-L.H., Bird, C., Ragnhammar, P., Lilljefors, M., Gaines-Das, R., Mellstedt, H., Thorpe, R. ( 1999 ). Immunogenicity of granulocyte-macrophage colony stimulating factor (GM-CSF) products in patients undergoing combination therapy with GM-CSF . Clin Can Res, 5, 1353-1361 .
-
(1999)
Clin Can Res
, vol.5
, pp. 1353-1361
-
-
Wadhwa, M.1
Skog, A.-L.H.2
Bird, C.3
Ragnhammar, P.4
Lilljefors, M.5
Gaines-Das, R.6
Mellstedt, H.7
Thorpe, R.8
-
34
-
-
0029920487
-
Production of neutralizing GM-CSF antibodies in carcinoma patients following GM-CSF combination therapy
-
Wadhwa, M., Bird, C., Fagerberg, J., Gaines-Das, R., Ragnhammar, P., Mellstedt, H., Thorpe, R. ( 1996 ). Production of neutralizing GM-CSF antibodies in carcinoma patients following GM-CSF combination therapy . Clin Exp Immunol, 104, 351-358 .
-
(1996)
Clin Exp Immunol
, vol.104
, pp. 351-358
-
-
Wadhwa, M.1
Bird, C.2
Fagerberg, J.3
Gaines-Das, R.4
Ragnhammar, P.5
Mellstedt, H.6
Thorpe, R.7
-
35
-
-
79551583401
-
Case study: immunogenicity of natalizumab
-
van der Weert M, Moller EH, eds. Springer, New York ; AAPS Press
-
Subramanyam, M. ( 2008 ). Case study: immunogenicity of natalizumab . In Biotechnology: Pharmaceutical Aspects, Vol VIII . Immunogenicity of Biopharmaceuticals . van der Weert M, Moller EH, eds. Springer, New York ; AAPS Press .
-
(2008)
Biotechnology: Pharmaceutical Aspects, Immunogenicity of Biopharmaceuticals
, vol.8
-
-
Subramanyam, M.1
-
36
-
-
7944234691
-
Development and validation of a cell-based bioassay for the detection of neutralizing antibodies against recombinant human erythropoietin in clinical studies
-
Wei, X., Swanson, S.J., Gupta, S. ( 2004 ). Development and validation of a cell-based bioassay for the detection of neutralizing antibodies against recombinant human erythropoietin in clinical studies . J Immunol Methods, 293, 115-126 .
-
(2004)
J Immunol Methods
, vol.293
, pp. 115-126
-
-
Wei, X.1
Swanson, S.J.2
Gupta, S.3
-
37
-
-
33947322141
-
Development and validation of a real time PCR-based bioassay for quantification of neutralizing antibodies against human interferon-beta
-
Bertolotto, A., Sala, A., Caldano, M., Capobianco, M., Malucchi, S., Marnetto, F., Gilli, D. ( 2007 ). Development and validation of a real time PCR-based bioassay for quantification of neutralizing antibodies against human interferon-beta . J Immunol Methods, 321 ( 1-2 ), 19-31 .
-
(2007)
J Immunol Methods
, vol.321
, Issue.1-2
, pp. 19-31
-
-
Bertolotto, A.1
Sala, A.2
Caldano, M.3
Capobianco, M.4
Malucchi, S.5
Marnetto, F.6
Gilli, D.7
-
38
-
-
65649116948
-
A bioactive drug quantitation based approach for the detection of anti-drug neutralizing antibodies in human serum
-
Hu, J., Gupta, S., Swanson, S.J., Zhuang, Y. ( 2009 ). A bioactive drug quantitation based approach for the detection of anti-drug neutralizing antibodies in human serum . J Immunol Methods, 345 ( 1-2 ), 70-79 .
-
(2009)
J Immunol Methods
, vol.345
, Issue.1-2
, pp. 70-79
-
-
Hu, J.1
Gupta, S.2
Swanson, S.J.3
Zhuang, Y.4
-
39
-
-
20444424922
-
The detection of anti-erythropoietin antibodies in human serum and plasma. Part II. Validation of a semi-quantitative 3H-thymidine uptake assay for neutralizing antibodies
-
Kelley, M., Cooper, C., Matticoli, A., Greway, A. ( 2005 ). The detection of anti-erythropoietin antibodies in human serum and plasma. Part II. Validation of a semi-quantitative 3H-thymidine uptake assay for neutralizing antibodies . J Immunol Methods, 300, 179-191 .
-
(2005)
J Immunol Methods
, vol.300
, pp. 179-191
-
-
Kelley, M.1
Cooper, C.2
Matticoli, A.3
Greway, A.4
-
40
-
-
59049104823
-
Measurement of neutralising antibodies to type I interferons by gene expression assays specific for type I interferon-inducible 6-16 mRNA
-
Moore, M., Meager, A., Wadhwa, M., Burns, C. ( 2009 ). Measurement of neutralising antibodies to type I interferons by gene expression assays specific for type I interferon-inducible 6-16 mRNA . J Pharm Biomed Anal, 49, 534-539 .
-
(2009)
J Pharm Biomed Anal
, vol.49
, pp. 534-539
-
-
Moore, M.1
Meager, A.2
Wadhwa, M.3
Burns, C.4
-
41
-
-
46449100977
-
Quantification of neutralizing antibodies to human type I interferons using division-arrested frozen cells carrying an interferon-regulated reporter-gene
-
Lallemand, C.J., Meritet, F., Erickson, R., Grossberg, S.E., Roullet, E., Lyon-Caen, O., et al. ( 2008 ). Quantification of neutralizing antibodies to human type I interferons using division-arrested frozen cells carrying an interferon-regulated reporter-gene . J Interferon Cytokine Res, 28, 393-404 .
-
(2008)
J Interferon Cytokine Res
, vol.28
, pp. 393-404
-
-
Lallemand, C.J.1
Meritet, F.2
Erickson, R.3
Grossberg, S.E.4
Roullet, E.5
Lyon-Caen, O.6
-
42
-
-
33747619436
-
Development and validation of a quasi-quantitative bioassay for neutralizing antibodies against CP-870893
-
Baltrukonis, D., Finco-Kent, D., Poirier, M., LeSauteur, L., Kawabata, K. ( 2006 ). Development and validation of a quasi-quantitative bioassay for neutralizing antibodies against CP-870893 . J Immunotoxicol, 3, 157-164 .
-
(2006)
J Immunotoxicol
, vol.3
, pp. 157-164
-
-
Baltrukonis, D.1
Finco-Kent, D.2
Poirier, M.3
LeSauteur, L.4
Kawabata, K.5
-
43
-
-
35848955440
-
Application of analytical detection concepts to immunogenicity testing
-
Klakamp, S.L., Lu, H., Tabrizi, M., Funelas, C., Roskos, L.K., Coleman, D. ( 2007 ). Application of analytical detection concepts to immunogenicity testing . Anal Chem, 79, 8176-8184 .
-
(2007)
Anal Chem
, vol.79
, pp. 8176-8184
-
-
Klakamp, S.L.1
Lu, H.2
Tabrizi, M.3
Funelas, C.4
Roskos, L.K.5
Coleman, D.6
-
44
-
-
0027457620
-
Receiver-operating characteristic (ROC) plots: a fundamental evaluation tool in clinical medicine
-
Zwieg, M.H., Campbell, G. ( 1993 ). Receiver-operating characteristic (ROC) plots: a fundamental evaluation tool in clinical medicine . Clin Chem, 39, 561-577 .
-
(1993)
Clin Chem
, vol.39
, pp. 561-577
-
-
Zwieg, M.H.1
Campbell, G.2
-
45
-
-
24344448252
-
An acid dissociation bridging ELISA for detection of antibodies directed against therapeutic proteins in the presence of antigen
-
Patton, A., Mullenix, M.C., Swanson, S.J., Koren, E. ( 2005 ). 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)
J Immunol Methods
, vol.304
, pp. 189-195
-
-
Patton, A.1
Mullenix, M.C.2
Swanson, S.J.3
Koren, E.4
-
46
-
-
34548861488
-
An affinity capture elution (ACE) assay for detection of anti-drug antibody to monoclonal antibody therapeutics in the presence of high levels of drug
-
Bourdage, J.S., Cook, C.A., Farrington, D.L., Chain, J.S., Konrad, R.J. ( 2007 ). An affinity capture elution (ACE) assay for detection of anti-drug antibody to monoclonal antibody therapeutics in the presence of high levels of drug . J Immunol Methods, 327, 10-17 .
-
(2007)
J Immunol Methods
, vol.327
, pp. 10-17
-
-
Bourdage, J.S.1
Cook, C.A.2
Farrington, D.L.3
Chain, J.S.4
Konrad, R.J.5
-
47
-
-
41949096282
-
Improvement of drug tolerance in immunogenicity testing by acid treatment on Biacore
-
Sickert, D., Kroeger, K., Zickler, C., Chokote, E., Winkler, B., Grenet, J.M., Legay, F., Zaar, A. ( 2008 ). Improvement of drug tolerance in immunogenicity testing by acid treatment on Biacore . J Immunol Methods, 334 ( 1-2 ), 29-36 .
-
(2008)
J Immunol Methods
, vol.334
, Issue.1-2
, pp. 29-36
-
-
Sickert, D.1
Kroeger, K.2
Zickler, C.3
Chokote, E.4
Winkler, B.5
Grenet, J.M.6
Legay, F.7
Zaar, A.8
-
48
-
-
40849142102
-
Cetuximab-induced anaphylaxis and IgE specific for galactose-alpha-1,3-galactose
-
Chung, C.H., Mirakhur, B., Chan, E., Le, Q.T., Berlin, J., Morse, M., Murphy, B.A., Satinover, S.M., Hosen, J., Mauro, D., Slebos, R.J., Zhou, Q., Gold, D., Hatley, T., Hicklin, D.J., Platts-Mills, T.A. ( 2008 ). Cetuximab-induced anaphylaxis and IgE specific for galactose-alpha-1,3-galactose . N Engl J Med, 358 ( 11 ), 1109-1117 .
-
(2008)
N Engl J Med
, vol.358
, Issue.11
, pp. 1109-1117
-
-
Chung, C.H.1
Mirakhur, B.2
Chan, E.3
Le, Q.T.4
Berlin, J.5
Morse, M.6
Murphy, B.A.7
Satinover, S.M.8
Hosen, J.9
Mauro, D.10
Slebos, R.J.11
Zhou, Q.12
Gold, D.13
Hatley, T.14
Hicklin, D.J.15
Platts-Mills, T.A.16
|