-
1
-
-
9644287732
-
A risk-based approach to immunogenicity concerns of therapeutic protein products, part I: Considering consequences of the immune response to a protein
-
Rosenberg AS, Worobec A. A risk-based approach to immunogenicity concerns of therapeutic protein products, part I: considering consequences of the immune response to a protein. Biopharm. Intl 17(11), 22-26 (2004).
-
(2004)
Biopharm. Intl
, vol.17
, Issue.11
, pp. 22-26
-
-
Rosenberg, A.S.1
Worobec, A.2
-
2
-
-
34249684926
-
A risk-based bioanalytical strategy for the assessment of antibody immune responses against biological drugs
-
Shankar G, Pendley C, Stein KE. A risk-based bioanalytical strategy 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
-
4
-
-
3142534409
-
Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products
-
Mire-Sluis AR, Barrett C, Devanarayan V et al. Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products. J. Immunol. Methods 289(1-2), 1-16 (2004)
-
(2004)
J. Immunol. Methods
, vol.289
, Issue.1-2
, pp. 1-16
-
-
Mire-Sluis, A.R.1
Barrett, C.2
Devanarayan, V.3
-
6
-
-
23944447879
-
Validation of immunoassays used to assess immunogenicity to therapeutic monoclonal antibodies
-
Geng D, Shankar G, Schantz A et al. Validation of immunoassays used to assess immunogenicity to therapeutic monoclonal antibodies. J. Pharm. Biomed. Anal. 39, 364-375 (2005).
-
(2005)
J. Pharm. Biomed. Anal.
, vol.39
, pp. 364-375
-
-
Geng, D.1
Shankar, G.2
Schantz, A.3
-
7
-
-
33947397632
-
Recommendations for the design, optimization, and qualifcation of cell-based assays used for the detection of neutralizing antibody responses elicited to biological therapeutics
-
Gupta S, Indelicato SR, Jethwa V et al. Recommendations for the design, optimization, and qualifcation of cell-based assays used for the detection of neutralizing antibody responses elicited to biological therapeutics. J. Immunol. Methods 321, 1-18 (2007).
-
(2007)
J. Immunol. Methods
, vol.321
, pp. 1-18
-
-
Gupta, S.1
Indelicato, S.R.2
Jethwa, V.3
-
8
-
-
58249116651
-
Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products
-
Shankar G, Devanarayan V, Amaravadi L et al. Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products J. Pharm. Biomed. Anal. 48(5), 1267-1281 (2008).
-
(2008)
J. Pharm. Biomed. Anal.
, vol.48
, Issue.5
, pp. 1267-1281
-
-
Shankar, G.1
Devanarayan, V.2
Amaravadi, L.3
-
9
-
-
0142122415
-
Validation of the BIACORE 3000 platform for detection of antibodies against erythropoietic agents in human serum samples
-
Mason S, La S, Mytych D et al. Validation of the BIACORE 3000 platform for detection of antibodies against erythropoietic agents in human serum samples. Curr. Med. Res. Opin. 19, 651-659 (2003).
-
(2003)
Curr. Med. Res. Opin.
, vol.19
, pp. 651-659
-
-
Mason, S.1
La Mytych, S.D.2
-
10
-
-
34249307306
-
Critical ligand binding reagent preparation/selection: When specifcity depends on reagents
-
Rup B, O'Hara D. Critical ligand binding reagent preparation/selection: when specifcity depends on reagents. AAPS J. 9(2), 16 E148 (2007).
-
(2007)
AAPS J.
, vol.9
, Issue.2
-
-
Rup, B.1
O'Hara, D.2
-
11
-
-
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. 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).
-
(2006)
J. Immunol. Methods
, vol.313
, pp. 176-182
-
-
Gross, J.1
Moller, R.2
Henke, W.3
Hoesel, W.4
-
13
-
-
36848999429
-
Evaluation of immunogenicity of the t cell costimulation modulator abatacept in patients treated for rheumatoid arthritis
-
Haggerty HG, Abbott MA, Reilly TP et al. Evaluation of immunogenicity of the t cell costimulation modulator abatacept in patients treated for rheumatoid arthritis. J. Rheumatol. 34, 2365-2373 (2007).
-
(2007)
J. Rheumatol.
, vol.34
, pp. 2365-2373
-
-
Haggerty, H.G.1
Abbott, M.A.2
Reilly, T.P.3
-
15
-
-
77958463367
-
Elimination of rheumatoid factor interference in immunoassays using the electrochemical (ECL) based Meso Scale Discovery (MSD) platform
-
Bautista AC, Yue E, Chirmule N, Swanson S, Jawa V. Elimination of rheumatoid factor interference in immunoassays using the electrochemical (ECL) based Meso Scale Discovery (MSD) platform. FASEB J. 22, lb566 (2008).
-
(2008)
FASEB J.
, vol.22
-
-
Bautista, A.C.1
Yue, E.2
Chirmule, N.3
Swanson, S.4
Jawa, V.5
-
16
-
-
84906676403
-
Validation of a cell based assay to detect antidrug neutralizing antibodies in cynomolgus monkey serum pretreated with Pierce Melon Gel™
-
San Francisco, CA, USA, 5-8 June
-
Nadar A, Gupta S, Kaliyaperumal A et al. Validation of a cell based assay to detect antidrug neutralizing antibodies in cynomolgus monkey serum pretreated with Pierce Melon Gel™. Presented at: National Biotechnology Conference. San Francisco, CA, USA 5-8 June 2005.
-
(2005)
Presented At: National Biotechnology Conference
-
-
Nadar, A.1
Gupta, S.2
Kaliyaperumal, A.3
-
17
-
-
79551583401
-
Case study: Immunogenicity of natalizumab
-
Van de Weert M, Moller EH (Eds). Springer AAPS Press, The Netherlands
-
Subramanyam M. Case study: immunogenicity of natalizumab. In: Immunogenicity of Biopharmaceuticals. Van de Weert M, Moller EH (Eds). Springer AAPS Press, The Netherlands (2008).
-
(2008)
Immunogenicity of Biopharmaceuticals
-
-
Subramanyam, M.1
-
18
-
-
84906676401
-
Comparison of assay technologies for immunogenicity measurement
-
Toronto, ON, Canada, June 23-24
-
Peng K, Siradze K, Araujo J et al. Comparison of assay technologies for immunogenicity measurement. Presented at: National Biotechnology Conference. Toronto, ON, Canada June 23-24, 2008.
-
(2008)
Presented At: National Biotechnology Conference
-
-
Peng, K.1
Siradze, K.2
Araujo, J.3
-
20
-
-
84906659958
-
Evaluation of assays for the detection of primary anti-human antibodies: ECL vs. ELISA
-
Boston, MA, USA, 18-21 June
-
Guo X, Fasulo LM, Finco-Kent D et al. Evaluation of assays for the detection of primary anti-human antibodies: ECL vs. ELISA. Presented at: National Biotechnology Conference. Boston, MA, USA 18-21 June 2006.
-
(2006)
Presented At: National Biotechnology Conference
-
-
Guo, X.1
Fasulo, L.M.2
Finco-Kent, D.3
-
21
-
-
41949096282
-
Improvement of drug tolerance in immunogenicity testing by acid treatment on Biacore
-
Sickert D, Kroeger K, Zickler C et al. Improvement of drug tolerance in immunogenicity testing by acid treatment on Biacore. J. Immunol. Methods 334(1-2), 29-36 (2008).
-
(2008)
J. Immunol. Methods
, vol.334
, Issue.1-2
, pp. 29-36
-
-
Sickert, D.1
Kroeger, K.2
Zickler, C.3
-
22
-
-
36048943918
-
Detection of antibodies against therapeutic proteins in the presence of residual therapeutic protein using a solid-phase extraction with acid dissociation (SPEAD) sample treatment prior to ELISA
-
Smith H W, Butterfeld A, Sun D et al. Detection of antibodies against therapeutic proteins in the presence of residual therapeutic protein using a solid-phase extraction with acid dissociation (SPEAD) sample treatment prior to ELISA. Regul. Toxicol. Pharmacol. 49, 230-237 (2007).
-
(2007)
Regul. Toxicol. Pharmacol.
, vol.49
, pp. 230-237
-
-
Smith, H.W.1
Butterfeld, A.2
Sun, D.3
-
23
-
-
51949091614
-
Assessing immunogenicity in the presence of excess protein therapeutic using immunoprecipitation and quantitative mass spectrometry
-
Neubert H, Grace C, Rumpel K et al. Assessing immunogenicity in the presence of excess protein therapeutic using immunoprecipitation and quantitative mass spectrometry. Anal. Chem. 80(18), 907-6914 (2008).
-
(2008)
Anal. Chem.
, vol.80
, Issue.18
, pp. 907-6914
-
-
Neubert, H.1
Grace, C.2
Rumpel, K.3
-
24
-
-
40849142102
-
Cetuximab-induced anaphylaxis and IgE specifc for galactose-a-1, 3-galactose
-
Chung CH, Mirakhur B, Chan E et al. Cetuximab-induced anaphylaxis and IgE specifc for galactose-a-1, 3-galactose. N. Engl. J. Med. 358, 1109-1117 (2008).
-
(2008)
N. Engl. J. Med.
, vol.358
, pp. 1109-1117
-
-
Chung, C.H.1
Mirakhur, B.2
Chan, E.3
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