-
1
-
-
0036861899
-
Immunogenicity of therapeutic proteins: clinical implications and future prospects
-
Schellekens, H. ( 2002 ). Immunogenicity of therapeutic proteins: clinical implications and future prospects . Clin Ther, 24, 1720-1740 .
-
(2002)
Clin Ther
, vol.24
, pp. 1720-1740
-
-
Schellekens, H.1
-
2
-
-
9644287732
-
A risk-based approach to immunogenicity concerns of therapeutic protein products. Part 1. Considering consequences of the immune response to a protein
-
Rosenberg, A.S., Worobec, A. ( 2004 ). 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)
Biopharm Int
, vol.17
, pp. 22-26
-
-
Rosenberg, A.S.1
Worobec, A.2
-
3
-
-
0038476357
-
Immunogenicity of therapeutic monoclonal antibodies
-
Pendley, C., Schantz, A., Wagner, C. ( 2003 ). Immunogenicity of therapeutic monoclonal antibodies . Curr Opin Mol Ther, 5, 172-179 .
-
(2003)
Curr Opin Mol Ther
, vol.5
, pp. 172-179
-
-
Pendley, C.1
Schantz, A.2
Wagner, C.3
-
4
-
-
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., Kelly, M., Anthony R., 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
Kelly, M.5
Anthony, R.6
Mire-Sluis, A.R.7
Richards, S.M.8
Rup, B.9
Shores, E.10
Swanson, S.J.11
Wakshull, E.12
-
5
-
-
0027238097
-
A monoclonal antibody to recombinant human IFN-cx receptor inhibits biologic activity of several species of human IFN-a, IFN-β, and IFN-?
-
Benoit, P., Maguire, D., Plavec, I., Kocher, H., Tovey, M., Meyer, F. ( 1993 ). A monoclonal antibody to recombinant human IFN-cx receptor inhibits biologic activity of several species of human IFN-a, IFN-β, and IFN-? . J Immunol, 150 ( 3 ), 707-716 .
-
(1993)
J Immunol
, vol.150
, Issue.3
, pp. 707-716
-
-
Benoit, P.1
Maguire, D.2
Plavec, I.3
Kocher, H.4
Tovey, M.5
Meyer, F.6
-
6
-
-
3242892400
-
Immunogenicity of recombinant human proteins: causes and consequences
-
Schellekens, H., Casadevall, N. ( 2004 ). Immunogenicity of recombinant human proteins: causes and consequences . J Neurol, 251 ( Suppl. 2 ), II/4-II/9 .
-
(2004)
J Neurol
, vol.251
, Issue.SUPPL. 2
-
-
Schellekens, H.1
Casadevall, N.2
-
7
-
-
0034518492
-
Spontaneous inhibitors to coagulation factors
-
Green, D. ( 2000 ). Spontaneous inhibitors to coagulation factors . Clin Lab Haematol, 22 ( Suppl. 1 ), 21-25 .
-
(2000)
Clin Lab Haematol
, vol.22
, Issue.SUPPL. 1
, pp. 21-25
-
-
Green, D.1
-
8
-
-
0037075272
-
Pure red-cell aplasia and antierythropoietin antibodies 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 antierythropoietin antibodies 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
-
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
-
-
0142039654
-
Strategies for detection, measurement and characterization of unwanted antibodies induced by therapeutic biologicals
-
Wadhwa, M., Bird, C., Dilger, P., Gaines-Das, R., Thorpe, R. ( 2003 ). Strategies for detection, measurement and characterization of unwanted antibodies induced by therapeutic biologicals . J Immunol Methods, 278, 1-17 .
-
(2003)
J Immunol Methods
, vol.278
, pp. 1-17
-
-
Wadhwa, M.1
Bird, C.2
Dilger, P.3
Gaines-Das, R.4
Thorpe, R.5
-
11
-
-
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., Barret, Y.C., Devanarayan, V., Gorovits, B., Gupta, S., Parish, T., Quanmby, 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, 1-9 .
-
(2008)
J Immunol Methods
, vol.333
, pp. 1-9
-
-
Koren, E.1
Smith, H.W.2
Shores, E.3
Shankar, G.4
Finco-Kent, D.5
Rup, B.6
Barret, Y.C.7
Devanarayan, V.8
Gorovits, B.9
Gupta, S.10
Parish, T.11
Quanmby, V.12
Moxness, M.13
Swanson, S.J.14
Taniguchi, G.15
Zuckerman, L.A.16
Stebbins, C.C.17
Mire-Sluis, A.18
-
12
-
-
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
-
13
-
-
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
-
14
-
-
84881558678
-
Assessment of unwanted immunogenicity
-
van de Weert M, Moller EH, eds, Springer, New York
-
Wadhwa, M., Thorpe, R. ( 2008 ). Assessment of unwanted immunogenicity . In Immunogenicity of Biopharmaceuticals . van de Weert M, Moller EH, eds. Springer, New York, pp. 57-73 .
-
(2008)
Immunogenicity of Biopharmaceuticals
, pp. 57-73
-
-
Wadhwa, M.1
Thorpe, R.2
-
15
-
-
33746889823
-
A high throughput electrochemiluminescent cell-binding assay for therapeutic anti-CD20 antibody selection
-
Lu, Y., Wong, W.L., Meng, Y.G. ( 2006 ). A high throughput electrochemiluminescent cell-binding assay for therapeutic anti-CD20 antibody selection . J Immunol Methods, 314, 74-79 .
-
(2006)
J Immunol Methods
, vol.314
, pp. 74-79
-
-
Lu, Y.1
Wong, W.L.2
Meng, Y.G.3
-
16
-
-
0347849050
-
Electrochemiluminescence-based detection of beta-lactam antibiotics and beta-lactamases
-
Liang, P., Sanchez, R.I., Martin, M.T. ( 1996 ). Electrochemiluminescence-based detection of beta-lactam antibiotics and beta-lactamases . Anal Chem, 68, 2426-2431 .
-
(1996)
Anal Chem
, vol.68
, pp. 2426-2431
-
-
Liang, P.1
Sanchez, R.I.2
Martin, M.T.3
-
17
-
-
14744295939
-
Electrochemiluminescence: a new diagnostic and research tool. ECL detection technology promises scientists new " yardsticks " for quantification
-
Yang, H., Leland, J.K., Yost, D., Massey, R.J. ( 1994 ). Electrochemiluminescence: a new diagnostic and research tool. ECL detection technology promises scientists new " yardsticks " for quantification . Biotechnology (NY), 12, 193-194 .
-
(1994)
Biotechnology (NY)
, vol.12
, pp. 193-194
-
-
Yang, H.1
Leland, J.K.2
Yost, D.3
Massey, R.J.4
-
18
-
-
35348995026
-
Detection of high-and low-affinity antibodies against a human monoclonal antibody using various technology platforms
-
Liang, M., Klakamp, S.L., Funelas, C., Lu, H., Lam, B., Herl, C., Umble, A., Drake, A.W., Pak, M., Ageyeva, N., Pasumarthi, R., Roskos, L.K. ( 2007 ). Detection of high-and low-affinity antibodies against a human monoclonal antibody using various technology platforms . Assay Drug Dev Technol, 5, 655-662 .
-
(2007)
Assay Drug Dev Technol
, vol.5
, pp. 655-662
-
-
Liang, M.1
Klakamp, S.L.2
Funelas, C.3
Lu, H.4
Lam, B.5
Herl, C.6
Umble, A.7
Drake, A.W.8
Pak, M.9
Ageyeva, N.10
Pasumarthi, R.11
Roskos, L.K.12
-
19
-
-
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 . Nat Biotechnol, 25, 555-561 .
-
(2007)
Nat Biotechnol
, vol.25
, pp. 555-561
-
-
Shankar, G.1
Pendley, C.2
Stein, K.E.3
-
21
-
-
0033855618
-
Monoclonal antibodies and the FACS: complementary tools for immunobiology and medicine
-
Herzenberg, L.A., De Rosa, S.C. ( 2000 ). Monoclonal antibodies and the FACS: complementary tools for immunobiology and medicine . Immunol Today, 21, 383-390 .
-
(2000)
Immunol Today
, vol.21
, pp. 383-390
-
-
Herzenberg, L.A.1
De Rosa, S.C.2
-
22
-
-
0026636315
-
Detection of cell-surface molecules, secreted products of single cells and cellular proliferation by enzyme immunoassay
-
Sedgwick, J.D., Czerkinsky, C. ( 1992 ). Detection of cell-surface molecules, secreted products of single cells and cellular proliferation by enzyme immunoassay . J Immunol Methods 150, 159-175 .
-
(1992)
J Immunol Methods
, vol.150
, pp. 159-175
-
-
Sedgwick, J.D.1
Czerkinsky, C.2
-
23
-
-
65649090964
-
Technology comparisons for anti-therapeutic antibody and neutralizing antibody assays in the context of an anti-TNF pharmacokinetic study
-
Loyet, K.M., Deng, R., Laing, W.C., Wu, Y., Lowman, H.B., DeForge, L.E. ( 2009 ). Technology comparisons for anti-therapeutic antibody and neutralizing antibody assays in the context of an anti-TNF pharmacokinetic study . J Immunol Methods, 345, 17-28 .
-
(2009)
J Immunol Methods
, vol.345
, pp. 17-28
-
-
Loyet, K.M.1
Deng, R.2
Laing, W.C.3
Wu, Y.4
Lowman, H.B.5
DeForge, L.E.6
-
24
-
-
58249116651
-
Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products
-
Shankar, G., Devanaryan, V., Amaravadi, L., Barret, Y.C., Bowsher, R., Finco-Kent, D., Fischella, M., Gorovits, B., Kirschner, S., Moxness, M., Parish, T., Quarmby, V., Smith, H., Smith, W., Zuckerman, L.A., 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 .
-
(2008)
J Pharm Biomed Anal
, vol.48
, pp. 1267-1281
-
-
Shankar, G.1
Devanaryan, V.2
Amaravadi, L.3
Barret, Y.C.4
Bowsher, R.5
Finco-Kent, D.6
Fischella, M.7
Gorovits, B.8
Kirschner, S.9
Moxness, M.10
Parish, T.11
Quarmby, V.12
Smith, H.13
Smith, W.14
Zuckerman, L.A.15
Koren, E.16
-
25
-
-
23944447879
-
Validation of immunoassays used to assess immunogenicity to therapeutic monoclonal antibodies
-
Geng, D., Shankar, G., Schantz, A., Rajadhyaksha, M., Davis, H., Wagner, C. ( 2005 ). Validation of immunoassays used to assess immunogenicity to therapeutic monoclonal antibodies . J Pharm Biomed Anal, 39, 364-375 .
-
(2005)
J Pharm Biomed Anal
, vol.39
, pp. 364-375
-
-
Geng, D.1
Shankar, G.2
Schantz, A.3
Rajadhyaksha, M.4
Davis, H.5
Wagner, C.6
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