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Enter author, analyte, or keyword to search publications.
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| Cludts, I., Meager, A., Thorpe, R., Wadhwa, M. (2010) Detection of neutralizing interleukin-17 antibodies in autoimmune polyendocrinopathy syndrome-1 (APS-1) patients using a novel non-cell based electrochemiluminescence assay. Cytokine. Vol. 50(2):129-37.
IL17, Interleukin, Neutralizing antibodies, Cell based assay, Competitive ligand binding assay
Summary: This study was based on the development of a non-cell based ELISA assay on the MSD® platform for the detection of neutralizing antibodies to IL-17A in patients with APS-1. The MSD bridging immunogenicity assay correlated very well with the traditional cell-based ELISA and was determined to be simple to perform, reliable, and more accessible to clinical laboratories than cell-based assays.
Matrix tested: Human serum
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| Myler, H.A., McVay, S., Kratzsch, J. (2010) Troubleshooting PEG-hGH detection supporting pharmacokinetic evaluation in growth hormone deficient patients. J Pharmacol Toxicol Methods. Vol. 61(2):92-7.
Acid dissociation, Drug detection methods, Growth hormone, Human serum, Pharmacokinetics, Total versus free ligand binding assays
Summary: Pharmacokinetic evaluation of clinical samples containing pegylated human growth hormone was done on the MSD platform by using an anti-PEG IgM monoclonal antibody as the capture reagent and a neutralizing anti-hGH IgG polyclonal antibody as the detection reagent.
Special Techniques: Acid dissociation of samples was done to enable the detection of epitopes masked by pegylation of the drug
Matrix tested: Human serum
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| Oh, C.K., Faggioni, R., Jin, F., Roskos, L.K., Wang, B., Birrell, C., Wilson, R., Molfino, N. (2010) An open-label, single-dose bioavailability study of the pharmacokinetics of CAT-354 after subcutaneous and intravenous administration in healthy males. British Journal of Clinical Pharmacology. 24 Feb 2010.
Acid dissociation, anti drug antibody, asthma, phase I
Summary: This study was based on the characterization of the pharmacokinetics of CAT-354 (anti-IL-13 human monoclonal antibody) following subcutaneous and intravenous administrations of 150 mg and 300 mg doses.
Special Techniques: Acid dissociation of samples was done to enable the detection of masked epitopes
Matrix tested: Human serum
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| Schlain, B., Amaravadi, L., Donley, J., Wickramasekera, A., Bennett, D., Subramanyam, M. (2010) A novel gamma-fitting statistical method for anti-drug antibody assays to establish assay cut points for data with non-normal distribution. J Immunol Methods. Vol. 352(1-2):161-8.
Immunogenicity, anti drug antibody, Cut point, Nonparametric, Gamma distribution, Screening assay
Summary: This paper describes a new 3-parameter gamma fit for non-normal immunogenicity data distributions, which tend to be unimodal and positively skewed. Gamma based cut points were found to be more accurate compared to normal or log-normal methods and more precise compared with the nonparametric percentile method.
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| Tatarewicz, S., Miller, J.M., Swanson, S.J., Moxness, M.S. (2010) Rheumatoid factor interference in immunogenicity assays for human monoclonal antibody therapeutics. J Immunol Methods. Vol. 357(1-2):10-6.
Rheumatoid Factor, Rheumatoid Arthritis, Therapeutic monoclonal antibody, Immunogenicity, HAHA, Aggregation, Interference
Summary: The role of interference by rheumatoid factors in HAHA (human anti-human antibody) immunoassays has been investigated in this paper using a highly sensitive bridging assay on MSD platform. Stability studies of the ruthenium and biotin conjugated therapeutic antibody and the integrity of the reagents were tested using SE-HPLC (Size exclusion high performance liquid chromatography).
Special Techniques: Size exclusion high performance liquid chromatography was done to test integrity of the reagents
Matrix tested: Human serum
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| Zhong, Z.D., Dinnogen, S., Hokom, M., Ray, C., Weinreich, D., Swanson, S.J., Chirmule, N. (2010) Identification and inhibition of drug target interference in immunogenicity assays. J Immunol Methods. Vol. 355(1-2):21-8.
Angiopoietin, Anti-drug antibody, Drug target interference, Immunoassay, Immunogenicity, acid dissociation
Summary: This paper reports the development and validation of a sensitive bridging ECL immunoassay to detect anti drug antibodies (ADA) against AMG 386, which is a peptide-Fc fusion protein that inhibits angiogenesis.
Special Techniques: Acid dissociation of samples was done to enable antibody–drug complex dissociation before analysis
Matrix tested: Human serum
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| 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. Vol. 345(1-2):70-9.
Immunogenicity, Neutralizing antibodies
Summary: The development of an immunoassay on MSD plates for the detection of effective neutralizing antibodies (Nabs) to Hepatocyte Growth Factor (HGF) antibody has been described here. The assay measured the level of biologically active drug concentration rather than detecting the mere presence of Nabs.
Matrix tested: Human serum
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| Loizos, N., Lariccia, L., Weiner, J., Griffith, H., Boin, F., Hummers, L., Wigley, F., Kussie, P. (2009) Lack of detection of agonist activity by antibodies to platelet-derived growth factor receptor alpha in a subset of normal and systemic sclerosis patient sera. Arthritis Rheum. Vol. 60(4):1145-51.
sclerosis, auto-antibodies
Summary: The presence of anti–platelet-derived growth factor receptor alpha (anti-PDGFRa) antibodies in the serum of patients with systemic sclerosis (SSc; scleroderma) was investigated to test whether auto-antibodies to PDGFRa are pathologically important in scleroderma. Bridging assays were developed on MSD plates to detect auto-antibodies specific for human PDGFRa, PDGFRß, colony-stimulating factor receptor 1 (CSFR1), epidermal growth factor receptor (EGFR), and a PDGFRa nonglycosylated form.
Matrix tested: Human serum
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| Loyet, K.M., Deng, R., Liang, 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. Vol. 345(1-2):17-28.
Anti-therapeutic antibody, Neutralizing antibody, Anti-TNF, Flow cytometry, Cynomolgus monkey
Summary: BioVeris and MSD platforms were compared in this paper for the development of immunoassay to detect anti-therapeutic antibody (ATA) against anti-TNF monoclonal antibody. To determine whether ATAs blocked binding of the anti-TNF mAbs, neutralizing antibody assays were done using MSD and flow cytometry.
Special Techniques: Bioveris, Flow cytometry, MSD
Matrix tested: Cynomolgus serum
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| Marchese, R.D., Puchalski, D., Miller, P., Antonello, J., Hammond, O., Green, T., Rubinstein, L.J., Caulfield, M.J., Sikkema, D. (2009) Optimization and validation of a multiplex, electrochemiluminescence-based detection assay for the quantitation of immunoglobulin g serotype-specific antipneumococcal antibodies in human serum. Clin Vaccine Immunol. Vol. 16 (3):387-96.
polysaccharide, Streptococcus pneumoniae, ELISA, Luminex
Summary: Immunogenicity of Pneumovax 23 vaccine was tested in this paper by developing and validating an MSD assay to measure the antibody response in human serum to eight serotypes within the vaccine in a single microtiter well. MSD was compared to ELISA and Luminex for assay development.
Special Techniques: Polysaccharides were directly immobilized to MSD plates without chemical conjugations for this assay
Matrix tested: Human serum
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| Ray, C.A., Patel, V., Shih, J., Macaraeg, C., Wu, Y., Thway, T., Ma, M., Lee, J.W., Desilva, B. (2009) Application of multi-factorial design of experiments to successfully optimize immunoassays for robust measurements of therapeutic proteins. J Pharm Biomed Anal. Vol. 49(2):311-8.
Tecan Evo pipettor, ELISA
Summary: In this paper, the authors describe a multi-factorial design of experiments (DOE) method as a tool for optimizing bridging immunoassays in therapeutic drug measurement and in immunogenicity assessment.
Matrix tested: Cynomolgus monkey serum, human serum
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| Thompson, I., McGiven, J., Sawyer, J., Thirlwall, R., Commander, N., Stack, J. (2009) Competitive electrochemiluminescence (ECL) wash and no-wash immunoassays for the detection of serum antibodies to smooth Brucella strains. Clin Vaccine Immunol. Vol. 16(5):765-71.
Veterinary Laboratories Agency, Brucella, bovine
Summary: In this study, the customer successfully converted existing competitive ELISA to MSD ECL assays for veterinary serodiagnosis of brucellosis. The potential of wash and no-wash MSD assays was assessed.
Matrix tested: Bovine serum
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Yao, K., Honarmand, S., Espinosa, A., Akhyani, N., Glaser, C., Jacobson, S. (2009) Detection of human herpesvirus-6 in cerebrospinal fluid of patients with encephalitis. Ann Neurol. Vol. 65(3):257-67.
Summary: This study investigated whether Human Herpesvirus-6 is a causative agent of encephalitis by determining the presence of viral sequence using Polymerase Chain Reaction (PCR) and assessing HHV-6 antibody reactivity in the cerebrospinal fluid of encephalitis patients.
Special Techniques: PCR, DNA sequencing
Matrix tested: Human cerebrospinal fluid (CSF)
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| Zalevsky, J., Leung, I.W., Karki, S., Chu, S.Y., Zhukovsky, E.A., Desjarlais, J.R., Carmichael, D.F., Lawrence, C.E. (2009) The impact of Fc engineering on an anti-CD19 antibody: increased Fcgamma receptor affinity enhances B-cell clearing in nonhuman primates. Blood. Vol. 113(16):3735-43.
Pharmacokinetics, non-human primate
Summary: This study determined the effectiveness of an Fc engineered anti-CD19 antibody in the treatment of B-cell malignancies in Cynomolgus monkeys. Immunogenicity of the parent-drug as well as Fc engineered version was tested by measurement of anti-drug antibodies with MSD assays.
Matrix tested: Cynomolgus monkey serum
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| Swanson, S. Evaluation of Antibodies in Clinical Trials of Cytokines in Cytokines in Human Health: Methods in Pharmacology and Toxicology. ed. House, R.V.and Descotes, J. (2008) Humana Press. Pages 259-274.
RIP, bioassay, surface plasmon resonance, Biacore, ELISA, ECL, electrochemiluminescence, radioimmunoprecipitation assay
Summary: This article reviews the immunogenicity of different cytokine drugs in terms of the factors causing it, the different methods for measurement and provides examples of immunogenicity issues of therapeutic cytokines.
Matrix tested: Cynomolgus monkey serum
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| Wadhwa, M., Thorpe, R. (2008) Assessment of Unwanted Immunogenicity in Immunogenicity of Biopharmaceuticals. Springer, New York. Pages 57-73.
RIP, bioassay, surface plasmon resonance, Biacore
Summary: This is a review article that describes the different methods and strategies to measure immunogenicity of therapeutic agents, and offers guidance on data interpretation. ELISA, electrochemiluminescent (ECL) assays, radioimmunoprecipitation (RIPA) assays, biosensor-based assays (such as Biacore) and cell-based neutralization assays have been described here to assess immunogenicity.
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| White, J.T., Martell, L.A., Van Tuyl, A., Boyer, R., Warness, L., Taniguchi, G.T., Foehr, E. (2008) Development, Validation, and Clinical Implementation of an Assay to Measure Total Antibody Response to Naglazyme(R) (Galsulfase). AAPS Journal. Vol. 10(2):363-72.
bridging immunoassay, enzyme replacement therapy, immunogenicity
Summary: Immunogenicity of the therapeutic agent, Naglazyme, was assessed in this study using a solution phase bridged immunoassay on the MSD platform.
Matrix tested: Human serum
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Yao, K., Gagnon, S., Akhyani, N., Williams, E., Fotheringham, J., Frohman, E., Stuve, O., Monson, N., Racke, M.K., Jacobson, S. (2008) Reactivation of human herpesvirus-6 in natalizumab treated multiple sclerosis patients. PLoS ONE. Vol. 3(4):e2028.
Summary: This study tested whether Human Herpesvirus-6 (HHV-6) is reactivated in multiple sclerosis (MS) patients treated with Natalizumab by examining sera and matched cerebrospinal fluid (CSF) from MS patients who were treated with natalizumab and comparing to MS patients not treated with the drug.
Matrix tested: Human serum and cerebrospinal fluid (CSF)
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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. (2007) Detection of High- and Low-Affinity Antibodies Against a Human Monoclonal Antibody Using Various Technology Platforms. Assay and Drug Dev Technol. Vol. 5(5): 1-8.
Summary: ELISA, MSD and Bioveris technologies were compared to determine the limit of detection of several anti-drug antibodies (ADAs) with a broad range of affinities to a human monoclonal antibody, ABX10.
Matrix tested: Human serum
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Liu, P.M, Handl, H., Zou, L, Kim, B. (2007) Immunobiological aspects of therapeutic antibodies and related characterization approaches. Curr Opin Drug Discov Devel. Vol. 10(5):515-22.
Summary: This review discusses the immunological and biological characteristics of therapeutic antibodies and the recent technologies that have been developed to help attain a better understanding of their mechanism of action.
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| 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(11):7467-72.
Acid dissociation, anti-epidermal growth factor receptor, biacore
Summary: In this paper, the immunogenicity of panitumumab was determined using two methods, ELISA and Biacore. Neutralizing antibodies against panitumumab were detected using MSD platform.
Special Techniques: Acid dissociation of samples was done to reduce drug interference
Matrix tested: Human serum
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Lu, Y., Young, J., Meng, Y.G. (2007) Electrochemiluminescence to detect surface proteins on live cells. Current Op Pharmacology. Vol. 7:541-546.
Summary: This paper discusses the development of an electrochemiluminescence assay method to be used as a tool to detect surface proteins on cells and compares it to traditional flow cytometry and cell based ELISA methods.
Special Techniques: Flow cytometry, cell based ELISA
Matrix tested: Human umbilical vein endothelial cells (HUVEC)
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| Swanson, S. J. (2007) Immunogenicity Issues in the Development of Therapeutic Proteins. Intl J Pharm Med. Vol. 21(3):207-216.
RIP, bioassay, surface plasmon resonance, Biacore
Summary: This is a review article that describes the different factors that result in immunogenicity of therapeutic agents and the various platforms as well as strategies that are available for measuring immunogenicity. The different methods listed here include ELISA, electrochemiluminescent (ECL) assays, radioimmunoprecipitation (RIPA) assays, biosensor-based assays (such as Biacore) and bioassays such as cell-based assays.
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Gillespie, B., Zia-Amirhosseini, P., Salfi, M., Kakkar, T., Wang, J., Gupta, S., Smith, B., Robson, R., Sullivan J.T. (2006) Effect of renal function on the pharmacokinetics of palifermin. J Clin Pharmacol. Vol. 46(12):1460-8.
Summary: Pharmacokinetic evaluation of palifermin drug was conducted in this study using MSD platform to assess the safety and tolerability of a single palifermin dose in subjects with varying degrees of renal function.
Matrix tested: Human serum
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| Lu, Y., Wong, W.L., Meng, Y.G. (2006) A high throughput electrochemiluminescent cell-binding assay for therapeutic anti-CD20 antibody selection. J Immunological Methods. Vol. 314(1-2):74-9.
Anti-CD20, Humanization, humanized, Cell binding assay, CHO, Chinese Hamster Ovary
Summary: A high-throughput ECL based cell-binding assay was developed in this study for measuring relative binding affinities of anti-CD20 antibody drug candidates to efficiently support humanization process.
Special Techniques: Cell binding assay was developed on MSD platform and compared to a pre-existing cell based ELISA
Matrix tested: Human serum
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| Zia-Amirhosseini, P., Salfi, M., Leese, P., Yates, W., Danilenko, D.M., Ring, B., Cesano, A., Sullivan, J.T. (2006) Pharmacokinetics, pharmacodynamics, and safety assessment of palifermin (rHuKGF) in healthy volunteers. Clinical Pharmacology & Therapeutics. Vol. 79: 558–569.
anti drug antibody, cancer therapy/p>
Summary: This paper is based on a randomized, double-blind, placebo-controlled study investigating the pharmacokinetics, pharmacodynamics, and safety of palifermin in healthy volunteers after single, escalating doses.
Special Techniques: Human sera were screened for anti-palifermin antibodies using MSD and the reactive samples were then tested in a cell-based ELISA to test for neutralizing antibodies to palifermin
Matrix tested: Human serum
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