-
1
-
-
0043095428
-
A real-Time immune-PCR assay for routine ultrasensitive quantification of proteins
-
Adler M, Wacker R, Niemeyer CM. A real-Time immune-PCR assay for routine ultrasensitive quantification of proteins. Biochem. Biophys. Res. Commun. 308(2), 240-250 (2003).
-
(2003)
Biochem. Biophys. Res. Commun.
, vol.308
, Issue.2
, pp. 240-250
-
-
Adler, M.1
Wacker, R.2
Niemeyer, C.M.3
-
2
-
-
44049102386
-
Sensitivity by combination: Immuno-PCR and related technologies
-
Adler M, Wacker R, Niemeyer CM. Sensitivity by combination: immuno-PCR and related technologies. Analyst 133(6), 702-718 (2008).
-
(2008)
Analyst
, vol.133
, Issue.6
, pp. 702-718
-
-
Adler, M.1
Wacker, R.2
Niemeyer, C.M.3
-
3
-
-
36049006592
-
Immunogenicity of protein therapeutics
-
De Groot AS, Scott DW. Immunogenicity of protein therapeutics. Trends Immunol. 28(11), 482-490 (2007).
-
(2007)
Trends Immunol.
, vol.28
, Issue.11
, pp. 482-490
-
-
De Groot, A.S.1
Scott, D.W.2
-
4
-
-
78651255385
-
-
European Agency for the Evaluation of Medicinal Products (EMEA), Committee for Medicinal Products for Human Use (CHMP), Biosimilar Medicinal Products Working Party (BMWP EMEA/CHMP/BMWP/114720/2009.
-
European Agency for the Evaluation of Medicinal Products (EMEA), Committee for Medicinal Products for Human Use (CHMP), Biosimilar Medicinal Products Working Party (BMWP), 2009. Concept paper on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use. EMEA/CHMP/BMWP/114720/2009. www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2009/09/WC500003910.pdf
-
(2009)
Concept Paper on Immunogenicity Assessment of Monoclonal Antibodies Intended for in Vivo Clinical Use.
-
-
-
5
-
-
41349116947
-
Risk based strategies for detection and characterization of antibodies against biotechnology products
-
Koren E. Risk based strategies for detection and characterization of antibodies against biotechnology products. J. Immunol. Methods 333, 1-9 (2008).
-
(2008)
J. Immunol. Methods
, vol.333
, pp. 1-9
-
-
Koren, E.1
-
6
-
-
58249116651
-
Recommendations for the validation of immunoassays used for the detection of host antibodies against biotechnology products
-
Shankar G, Devanarayan V, Amaravadi L et al. Recommendations for the validation of immunoassays used for the 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
-
7
-
-
78149354304
-
-
US Department of Health and Human Services/Food and Drug Administration/Center for Drug Evaluation and Research/Center for Biologics Evaluation and Research
-
US Department of Health and Human Services/Food and Drug Administration/Center for Drug Evaluation and Research/Center for Biologics Evaluation and Research, 2009. Guidance for industry: assay development for immunogenicity testing of therapeutic proteins. www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatory Information/Guidances/ UCM192750.pdf
-
(2009)
Guidance for Industry: Assay Development for Immunogenicity Testing of Therapeutic Proteins
-
-
-
8
-
-
33748770097
-
Confirming human antibody responses to a therapeutic monoclonal antibody using statistical approach
-
Neyer L, Hiller J, Gish K, Keller S, Caras I. Confirming human antibody responses to a therapeutic monoclonal antibody using statistical approach. J. Immunol. Methods 315, 80-87 (2006).
-
(2006)
J. Immunol. Methods
, vol.315
, pp. 80-87
-
-
Neyer, L.1
Hiller, J.2
Gish, K.3
Keller, S.4
Caras, I.5
-
9
-
-
3142534409
-
Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products
-
Mire-Sluis AR, Barrett YC, 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, Y.C.2
Devanarayan, V.3
-
10
-
-
15044351755
-
Immuno-PCR: High sensitivity detection of proteins by nucleic acid amplification
-
Niemeyer CM, Adler M, Wacker R. Immuno-PCR: high sensitivity detection of proteins by nucleic acid amplification. Trends Biotechnol. 23(4), 208-216 (2005).
-
(2005)
Trends Biotechnol.
, vol.23
, Issue.4
, pp. 208-216
-
-
Niemeyer, C.M.1
Adler, M.2
Wacker, R.3
-
11
-
-
34548154323
-
Detecting antigens by quantitative immuno-PCR
-
Niemeyer CM, Adler M, Wacker R. Detecting antigens by quantitative immuno-PCR. Nat. Protoc. 2(8), 1918-1930 (2007).
-
(2007)
Nat. Protoc.
, vol.2
, Issue.8
, pp. 1918-1930
-
-
Niemeyer, C.M.1
Adler, M.2
Wacker, R.3
-
12
-
-
0026644604
-
Immuno-PCR: Very sensitive antigen detection by means of specific antibody-DNA conjugates
-
Sano T, Smith CL, Cantor CR. Immuno-PCR: very sensitive antigen detection by means of specific antibody-DNA conjugates. Science 258(5079), 120-122 (1992).
-
(1992)
Science
, vol.258
, Issue.5079
, pp. 120-122
-
-
Sano, T.1
Smith, C.L.2
Cantor, C.R.3
-
13
-
-
68049120174
-
Immuno-PCR assays for immunogenicity testing
-
Spengler M, Adler M, Jonas A, Niemeyer CM. Immuno-PCR assays for immunogenicity testing. Biochem. Biophys. Res. Commun. 387(2), 278-282 (2009).
-
(2009)
Biochem. Biophys. Res. Commun.
, vol.387
, Issue.2
, pp. 278-282
-
-
Spengler, M.1
Adler, M.2
Jonas, A.3
Niemeyer, C.M.4
-
14
-
-
0142066078
-
Immunogenicity: Concepts/issues/concerns
-
Stein KE. Immunogenicity: concepts/issues/concerns. Dev. Biol. (Basel) 109, 15-23 (2002).
-
(2002)
Dev. Biol. (Basel)
, vol.109
, pp. 15-23
-
-
Stein, K.E.1
-
15
-
-
33744950980
-
Scientific and regulatory considerations on the immunogenicity of biologics
-
Shankar G, Shores E, Wagner C et al. 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
|