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| NEW! Valentin, M.A., Ma, S., Zhao, A., Legay, F., Avrameas, A. (2011) Validation of immunoassay for protein biomarkers: bioanalytical study plan implementation to support pre-clinical and clinical studies. J Pharm Biomed Anal. Vol. 55(5):869-77.
Novartis
Summary: The aim of this paper is to establish the procedures, parameters, and the acceptance criteria for the validation of immunoassays to support biomarker selection in preclinical and clinical studies.
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| Ren, D., Darlucio, M.R., Chou, J.H. (2011) Development of a multi-product leached protein A assay for bioprocess samples containing recombinant human monoclonal antibodies. J Immunol Methods. Vol. 366(1-2):20-7.
bioprocess
Analytes tested using MSD® assays: Protein A
Matrix tested: Assay diluent
Summary: In this study, a novel assay was developed on the MSD platform to determine the levels of protein A contamination during monoclonal antibody purification process. Acid dissociation was used to dissociate the IgG-protein A complex, followed by neutralization step. The authors noted the robustness, high sensitivity and efficiency of this assay for protein A determination. |
| Xie, R., Chung, J.Y., Ylaya, K., Williams, R.L., Guerrero, N., Nakatsuka, N., Badie, C., Hewitt, S.M. (2011) Factors influencing the degradation of archival formalin-fixed paraffin-embedded tissue sections. J Histochem Cytochem. Vol. 59(4):356-65.
Antigenicity, immunohistochemistry, protein array, tissue processing, FFPE
Analytes tested using MSD assays: GAPDH
Matrix tested: Protein extracted from formalin-fixed paraffin-embedded (FFPE) tissue
Summary: The aim of this study was to analyze the effect of residual water in FFPE tissues, either due to inadequate tissue processing or the presence of humidity during storage, on protein integrity and antigenicity. |
Miao, W., Ge, C. "Electrogenerated Chemiluminescence (ECL)". Encyclopedia of Supramolecular Chemistry (2010).
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| Bautista, A.C., Wullner, D., Moxness, M., Swanson, S.J., Chirmule, N., Jawa, V. (2010) Impact of matrix-associated soluble factors on the specificity of the immunogenicity assessment. Bioanalysis. Vol. 2(4): 721-731.
protein microarray, ELISA, MESO SCALE DISCOVERY, xMAP technology, Luminex, reverse phase assay, In-cell Western, LICOR, Flow cytometry, genomics, transcriptomics, metabolomics, proteomics
Summary: In this study, three different immunogenicity assay platforms were compared, including ELISA, MESO SCALE DISCOVERY platform and a real-time surface Plasmon resonance based platform (Biacore 3000). The results showed the effectiveness of Melon Gel pretreatment in combination with avidin high-bind plates from MSD in eliminating the interference due to rheumatoid factor. Recommendations have been provided on the choice of assay designs and platforms that can help eliminate interfering factors that impact the performance of immunogenicity assays.
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| Liang, S., Connell, G.J. (2010) Identification of specific inhibitors for a trypanosomatid RNA editing reaction. RNA. 2010 Oct 12. [Epub ahead of print].
trypanosomatid, Trypanosoma, Lieshmania, protoporphyrin, D-sphingosine, suramin
Analytes tested using MSD assays: Screen for inhibitors of RNA-editing reaction on MSD streptavidin coated plates
Matrix tested: Assay buffer
Summary: In this study, MSD platform was used to develop an ECL based aptamer switch assay to conduct a high throughput screen for inhibitors of a trypanosomatid RNA editing reaction. The assay is based on the use of a streptavidin-binding aptamer that gets activated by a conformational change due to editing.
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| Mao, H., Graziano, J.J., Chase, T.M., Bentley, C.A., Bazirgan, O.A., Reddy, N.P., Song, B.D., Smider, V.V. (2010) Spatially addressed combinatorial protein libraries for recombinant antibody discovery and optimization. Nat Biotechnol. Vol. 28(11):1195-202.
Fabrus, DLL4, alanine scanning mutagenesis
Analytes tested using MSD® assays: User built assay for screening of Fabs
Matrix tested: Assay buffer
Summary: In this study, MSD platform was utilized for high throughput screening of 10,000 purified Fabs against 9 multiplexed targets. The screening assay was run as a homogeneous no wash assay to detect low affinity interactions and hits were defined based on 4-fold higher signal than the negative control signal.
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| Newhall, K.J., Diemer, G.S., Leshinsky, N., Kerkof, K., Chute, H.T., Russell, C.B., Rees, W., Welcher, A.A., Patterson, S.D., Means, G.D. (2010) Evidence for endotoxin contamination in plastic Na+-heparin blood collection tube lots. Clin Chem. Vol. 56(9):1483-91. Epub 2010 Jul 27.
Interleukin, IL1b, IL-1b, IL1beta, IL-1ß, IL1ß, tumor necrosis factor, TNFa, TNF-a, TNF-a, TNFa, TNFalpha, Vacutainer, LPS, lipopolysaccharide
Analytes tested using MSD® assays: IL-1beta, TNF-alpha (MSD custom-coated plate)
Matrix tested: Human whole blood
Summary: The aim of this study was to investigate the effects on biomarker measurement due to endotoxin-like contamination associated with specific lots of blood collection tubes. Endotoxin exposure alters the inflammatory response in the cells, thereby masking patient response in clinical trials.
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| Tian-Yu, J., Licht, S., Pardee, G., Bhat, A., Cao, Y., Gao, W., Sangalang, E., Zaror, I. (2010) Binding Rate Screen - A high-throughput assay in soluble lysate for prioritizing protein expression constructs. Anal Biochem. Vol. 399(2):276-283.
High throughput, biosensor, ForteBio, Octet
Analytes tested using MSD assays: Expressed monomeric recombinant protein in cell lysate
Matrix tested: Cell lysate
Summary: In this paper, the authors developed a Binding Rate Screen (BRS) to select and prioritize recombinant tagged protein constructs as expressed in crude soluble lysate (CSL) by measuring the rates at which they bind to a tag-specific antibody and use this as a metric to reflect aggregation, concentration and purifiability.
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Williams, R., Chung, J.Y., Ylaya, K., Whiteley, G., Hewitt, S.M. (2010) Characterizations and validations of novel antibodies toward translational research. Proteomics. Vol. 4(6-7): 618–625.
Analytes tested using MSD assays:MSD platform was used for screening aviditiy of monoclonal antibodies
Matrix tested: NCI60 cell lysates
Summary: This paper describes a high-throughput screening assay using a reverse-phase protein array method and immunohistochemistry for the characterization and validation of monoclonal antibodies. The antibodies were screened on MSD plates coated with lysates that were prepared from NCI60 cell lines expressing the target antigen.
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| Alexopoulos, L.G., Saez-Rodriguez, J., Espelin, C.W. (2009) High-Throughput Protein-Based Technologies and Computational Models for Drug Development, Efficacy, and Toxicity in Drug Efficacy, Safety, and Biologics Discovery: Emerging Technologies and Tools. Ed. Ekins, S. Wiley InterScience.
protein microarray, ELISA, MESO SCALE DISCOVERY, xMAP technology, Luminex, reverse phase assay, In-cell Western, LICOR, Flow cytometry, genomics, transcriptomics, metabolomics, proteomics
Summary: This book chapter reviews the different high throughput technologies and their roles in the area of drug development, efficacy, and toxicity. Experimental platforms for protein measurements, multiplex technologies, data analysis, modeling and computation have been discussed in detail.
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| Rhyne, P.W., Wong, O.T., Zhang, Y.J., Weiner, R.S. (2009) Electrochemiluminescence in Bioanalysis. Bioanalysis Vol. 1(5):919-935.
ORIGEN Analyzer, BioVeris Analyzer, MESO SCALE DISCOVERY, multiplexing, capillary electrophoresis, hook effect
Summary: This is a review article that discusses the electrochemiluminescence technology and its principles in detail, as well as the applications of ECL-based assays in different fields including microbiology, immunology, neurodegenerative diseases, autoimmunity, cancer, infectious diseases, biowarfare and drug development. The advantages of ECL assays have been mentioned and examples have been provided.
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| Christensen, E., Evans, K.R., Menard, C., Pintilie, M., Bristow, R.G. (2008) Practical approaches to proteomic biomarkers within prostate cancer radiotherapy trials. Cancer Metastasis Rev. Vol. 27(3):375-85.
Radiotherapy, clinical trial, mass spectrometry, Luminex, XMAP, MESO SCALE DISCOVERY, ELISA, array
Summary: In this study, the authors investigated the proteomic signatures in immediate risk prostrate cancer patients receiving radiation therapy using multiplexed immunoassays. The importance of specimen acquisition, preparation and analysis, as well as the practical approaches to longitudinal biomarker studies has been discussed.
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| Chung, J., Lee, S., Kris, Y., Braunschweig, T., Traicoff, J., Hewitt, S. (2008) A well-based reverse-phase protein array applicable to extracts from formalin-fixed paraffin-embedded tissue. Proteomics Clin Appl. Vol. 2 (10-11):1539-1547.
Western blot, formalin fixed paraffin embedded tissue, Laser capture microdissection, Protein extraction, reverse phase protein array
Analytes tested using MSD assays: Prostrate specific antigen (PSA), GAPDH, smooth muscle actin
Matrix tested: Protein extracted from FFPE tissue
Summary: This paper discusses a new method for the optimization of protein extraction from formalin-fixed, paraffin embedded tissues to gain high quality intact protein for further analysis of biomarkers.
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| Daniels, D. Applicability of Biomarkers Is Far-Reaching. (2008) Gen Eng Biotech News. Vol. 28(14).
Pronota, NextGen Sciences
Summary: In this news article, the latest techniques used to advance biomarker research have been discussed. miRNA technique from Luminex, Ziplex Microarray Workstation from Xceed Molecular, UNIarray program from Protagen, biomarker development by Biotrin International, use of MESO SCALE DISCOVERY assays by Merck, reverse-phase protein microarray method from Theranostics Health, and several contract research organizations have been highlighted.
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| Dieterle, F., Marrer, E. (2008) New technologies around biomarkers and their interplay with drug development. Anal Bioanal Chem. Vol. 390(1):141-54.
MESO SCALE DISCOVERY, Luminex, VeraCode
Summary: This is a review paper that provides a critical examination of recently established platforms and technologies for biomarker development, and their applications from discovery to validation in genetics, genomics, proteomics, metabonomics and assay development.
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| Gerszten, R.E., Accurso, F., Bernard, G.R., Caprioli, R.M., Klee, E.W., Klee, G.G., Kullo, I., Laguna, T.A., Roth, F.P., Sabatine, M., Srinivas, P., Wang, T.J., Ware, L.B. (2008) Challenges in translating plasma proteomics from bench to bedside: update from the NHLBI Clinical Proteomics Programs. Am J Physiol Lung Cell Mol Physiol. Vol. 295(1):L16-22.
proteome
Summary: This paper discusses the highlights of a meeting held by the National Heart, Lung, and Blood Institute's (NHLBI) Clinical Proteomics Program committee which focused on the barriers to achieving effective translation of plasma protein biomarkers from discovery to clinical use, and the strategies for overcoming these challenges. The strengths and limitations of multiplexing platforms, including planar assays, bead-based assays and mass spectrometry, have been reviewed.
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| Jia, Y., Gu, X., Brinker, A., Warmuth, M. (2008) Measuring the tyrosine kinase activity: a review of biochemical and cellular assay technologies. Expert Opinion on Drug Discovery. Vol. 3(8) 959-978.
SPA, FlashPlate, ELISA, DELFIA, homogeneous time resolved fluorescence (HTRF), lanthanide chelate excitation, LANCE, Fluorescence polarization, AlphaScreen, Immobilized metal ion affinity partitioning, IMAP, Caliper technology, Z'-Lyte, Easylite, Kinase-Glo, PKLight, ADP Quest, MSD, SureFire, fluorescence quenching assay, IQ, Lightspeed, TruLight
Summary: This review provides a discussion on the different biochemical and cellular kinase assay technologies that are available, their principles, and their application in tyrosine kinase drug discovery. Radiometric assays, Scintillation proximity assays, fluorescence based assays, cell-based kinase assays, translocation assays, kinase sensor assays, and distal assays have been described here.
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Miao, W. (2008) Electrogenerated Chemiluminescence and Its Biorelated Applications. Chem Rev. Vol. 108(7):2506-2553.
Summary: This review paper discusses the fundamentals of electrochemiluminescence (ECL) technology, its principles and unique features with respect to other luminescence, mechanisms of different ECL systems, new developments, instrumentation, luminophores, and the various applications of ECL, especially in biological field.
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Russell, C.B., Suggs, S., Robson, K.M., Kerkof, K., Kivman, L.D., Notari, K.H., Rees, W.A., Leshinsky, N., Patterson, S.D. (2008) Biomarker Sample Collection and Handling in the Clinical Setting to Support Early-Phase Drug in Biomarker Methods in Drug Discovery and Development; Humana Press: 1-26.
Summary: This review provides an insight into the various aspects of biomarker analysis that need to be considered for generating robust data for pharmacodynamic studies. The issues discussed include sample selection, sample collection, and fit-for-purpose assay qualification.
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| van Oostrum J, Voshol. H. (2008) Antibody based Proteomics to Study Cellular Signaling Networks. Europ Pharma Review. Vol. 13(2):31-35.
LICOR, MESO SCALE DISCOVERY, Luminex, BioPlex, ZeptoChips, BD Phosflow
Summary: In this review, the authors discussed the different tools that are available for the analysis of phosphoproteins, including Western blotting, in-cell Western, solid phase immunoassays, bead based immunoassays, reverse phase assays, and flow cytometry.
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| Wei, J.S., Badgett, T.C., Khan, J. (2008) New technologies for diagnosing pediatric tumors. Expert Opin Med Diagn. Vol. 2(11):1205-1219.
bead based detection, genomic hybridization, isotope coded affinity tags, label free detection, DNA sequencing, MESO SCALE DISCOVERY, microarray, microRNA, polymerase chain reaction, reverse phase protein array, RT-PCR
Summary: This is a review paper that provides a discussion of new technologies including DNA microarray, multiplexed PCR, bead based assays, and protein detection methods that can be applied to the discovery of biomarkers related to the diagnosis of pediatric cancers.
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| Wingren, C., Borrebaeck, C.A.K. Protein Microarray Technologies for Detection and Identification of Bacterial and Protein Analytes In Principles of Bacterial Detection: Biosensors, Recognition Receptors and Microsystems. ed. Zourob, M. et al. p715-729. Springer, New York. 2008.
proteomics, antibody microarray, reverse phase protein array
Summary: This paper discusses the potential and specific use of functional protein microarrays and affinity protein microarrays for the detection and serotyping of bacteria, detection of bacterial proteins and toxins, and the identification of diagnostic biomarkers.
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| Blatny, J.M.. (2007) Detecting and Responding to Bioterrorism (Chapter) in Risk Assessment and Risk Communication Strategies in Bioterrorism Preparedness. ed. Green, M.S. et al. Springer Netherlands.
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Kadkhodayan, S., Elliott, L.O., Mausisa, G., Wallweber, H.A., Deshayes, K., Feng, B., Fairbrother, W.J. (2007) Evaluation of assay technologies for the identification of protein-Peptide interaction antagonists. Assay Drug Dev Technol. Vol. 5(4):501-13.
Summary: In this study, the authors compared several assay detection technologies that are routinely used in drug discovery. Multiple peptides were evaluated to develop a small molecule antagonist to the melanoma inhibitor of apoptosis protein using different assays, including ELISA, dissociation-enhanced lanthanide fluorescent immunoassay (DELFIA), electrochemiluminescence assay (BioVeris), amplified luminescent proximity homogeneous assay (AlphaScreen), time-resolved fluorescence resonance energy transfer (TR-FRET), and fluorescence polarization (FP).
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| Pyati, R., Richter, M.M. (2007) ECL-Electrochemical luminescence. Annu. Rep. Prog. Chem., Sect. C: Phys. Chem., Vol. 103:12-78.
DPA, tris-2,2'-bipyridylruthenium, High performance liquid chromatography (HPLC), capillary electrophoresis, BioVeris ORIGEN and M-SERIES, Roche Elecsys and MODULAR, NucliSens, Eisai PicoLumi, MESO SCALE DISCOVERY SECTOR
Summary: This paper provides a detailed review on the principles, luminophores (diphenylanthracene or Ru(bpy)32+)and applications of electrochemiluminescence technology.
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| Sarker, D., Pacey, S., Workman, P. (2007) Use of pharmacokinetic/ pharmacodynamic biomarkers to support rational cancer drug development. Biomarkers in Medicine. Vol. 1(3): 399-417.
cancer, antineoplastic agents, neoplasm
Summary: This is a review paper that discusses the importance and the use of pharmacokinetic and pharmacodynamic biomarkers in pre-clinical studies and the application of this information in clinical trials. Examples in the form of case studies have been provided that highlight the development, validation and use of these biomarkers in drug development. The challenges regarding the implementation of these biomarkers have also been discussed.
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Xu, X.H.N, Zu, Y. Electrochemiluminescence Detection in Bioanalysis in New Frontiers in Ultrasensitive Bioanalysis. ed. Zun X.H.N. (2007) John Wiley & Sons, Inc. 235-267.
Summary: The focus of this review paper is to discuss the fundamentals of electrochemiluminescence, the development of different ECL technologies, instrumentation, applications and the unique features of ECL method. Representative ECL assays and their applications in bioanalysis, and the current research in ECL mechanisms, new ECL emitters and coreactors have been presented.
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Simpson, P.B. (2006) A Model for Efficient Assay Development and Screening at a Small Research Site. J. Assoc. Lab Automation. Vol. 11(2):100-109.
Summary: This is a tutorial that describes a model in which a centralized assay team is developed which is highly skilled, has appropriate automation resources, is modest in expense and recruitment levels and has high productivity and efficiency. Such a group is capable of supporting all automated assay development and multiple types of screening.
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| Ramm, P. (2005) Image-based screening: a technology in transition. Curr Opin Biotechnol. Vol. 16(1):41-8.
fluorescence polarization (FP), fluorescence resonance energy transfer (FRET), SIBS, scintillation, ViewLux, LEADseeker
Summary: This review article describes the applications of image-based screening technology, including whole well biochemical screening, whole well cell screening, array screening, point target screening and subcellular screening. IBS, which is the analysis of data from digital images, is applied in screening for leads in drug discovery.
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Debad, J.D., Glezer, E.N., Wohlstadter, J.N., Sigal, G.B. (2004) Clinical and Biological Applications of ECL. in Electrogenerated Chemiluminescence, ed. A.J. Bard. Marcel Dekker, New York. 43-78.
Summary: This book chapter is a detailed review on the principle, instrumentation and assay formats of electrochemiluminescence technology, and the applications of these assays in the fields of life science research, clinical testing, food and water testing, and the detection of biowarfare agents.
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Pluskal, M.G., Bachmann, J. (2004) Advancing applications of microarrays. Drug Discov Today. Vol. 9(2):61-3.
Summary: This article lists the proceedings of Chips to Hits Conference, in which the developments in microarray technology, new surface chemistry and engineering methods as well as emerging technologies for target identification were discussed. Additionally, an overview of intellectual property and FDA regulation in product development was also provided.
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| Elands, J., Botwood, M.P. (2002) Meeting the challenges in screening. Drug Discov Today. Vol. 7(23):1162-4.
MESO SCALE DISCOVERY, Virtual Arrays, CellCards, zinc finger, Sangamo Biosciences, High Throughput Genomics
Summary: This review lists the proceedings of Society for Biomolecular Screening Eighth Annual Conference, held in Netherlands, in which novel screening methods, image based high content screening, different multiplexed immunoassay systems, use of computation for biological data analysis and structure function relationships of biological molecules were discussed.
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Bard, A.J., Debad, J.D., Leland, J.K., Sigal, G.B., Wilbur, J.L., Wohlstadter, J.N. (2000) Chemiluminescence, Electrogenerated. in Encyclopedia of Analytical Chemistry, ed. Meyers, R.A. John Wiley & Sons, Chichester. 9842-9849.
Summary: This is a review paper on the theory, principles, analytical applications and instrumentation of electrochemiluminescent assays.
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