1. Pharmacokinetics of daclizumab high-yield process with repeated administration of the clinical subcutaneous regimen in patients with relapsing-remitting multiple sclerosis.

    Clinical Pharmacology Advances and Applications 8:9 (2016) PMID 26929672 PMCID PMC4755689

    Daclizumab high-yield process (DAC HYP), a humanized immunoglobulin G1 monoclonal antibody specific for the α subunit (CD25) of the high-affinity interleukin-2 receptor, has demonstrated efficacy for treatment of relapsing forms of multiple sclerosis in Phase II and III clinical trials. To chara...
  2. Emerging technologies to increase ligand binding assay sensitivity.

    AAPS Journal 17(1):93 (2015) PMID 25331105 PMCID PMC4287293

    Ligand binding assays (LBAs) have been the method of choice for protein analyte measurements for more than four decades. Over the years, LBA methods have improved in sensitivity and achieved larger dynamic ranges by using alternative detection systems and new technologies. As a consequence, the ...
  3. Recommendations for the development and validation of confirmatory anti-drug antibody assays.

    Bioanalysis 7(13):1619 (2015) PMID 26226311

    Identification and characterization of anti-drug antibodies is a critical component of biopharmaceutical drug development. The tiered approach for immunogenicity testing consists of screening, confirmatory, and characterization assays. Herein, we provide recommendations for confirmatory assays b...
  4. 2013 White Paper on recent issues in bioanalysis: 'hybrid'--the best of LBA and LCMS.

    Bioanalysis 5(23):2903 (2013) PMID 24107004

    The 2013 7th Workshop on Recent Issues in Bioanalysis was held in Long Beach, California, USA, where close to 500 professionals from pharmaceutical and biopharmaceutical companies, CROs and regulatory agencies convened to discuss current topics of interest in bioanalysis. These 'hot' topics, whi...
  5. A single ascending-dose study of BIIB037 in people with mild-to-moderate Alzheimer's disease

    Alzheimer's & Dementia 9(4):P290 (2013)

  6. Novel data analysis methods to overcome cut point challenges and enable comprehensive assessment of antidrug binding activity in confirmatory assays

    Journal of Immunological Methods 392(1-2):38 (2013)

    Immunogenicity assessments in response to drug treatment are commonly performed using a tiered approach strategy. All samples are initially tested in a screening assay followed by the evaluation of the screened positive samples in a confirmatory assay. Percent inhibition of signal inte...
  7. Solution ELISA as a platform of choice for development of robust, drug tolerant immunogenicity assays in support of drug development.

    Journal of Immunological Methods 365(1-2):38 (2011) PMID 21130095

    Humanized monoclonal antibody therapeutics are in many ways indistinguishable from the anti-therapeutic/anti-drug antibodies generated in humans. Therefore, immunogenicity assessments to such therapeutics pose unique challenges in clinical trials especially when significant drug interference is ...
  8. Proteomic patterns for classification of ovarian cancer and CTCL serum samples utilizing peak pairs indicative of post-translational modifications.

    Proteomics 7(22):4045 (2007) PMID 17952875

    Proteomic patterns as a potential diagnostic technology has been well established for several cancer conditions and other diseases. The use of machine learning techniques such as decision trees, neural networks, genetic algorithms, and other methods has been the basis for pattern determination. ...
  9. A robust biomarker discovery pipeline for high-performance mass spectrometry data.

    Journal of Bioinformatics and Computational Bio... 5(5):1023 (2007) PMID 17933009

    A high-throughput software pipeline for analyzing high-performance mass spectral data sets has been developed to facilitate rapid and accurate biomarker determination. The software exploits the mass precision and resolution of high-performance instrumentation, bypasses peak-finding steps, and in...
  10. Phosphopeptide analysis by directly coupling two-dimensional planar electrochromatography/thin-layer chromatography with matrix-assisted laser desorption/ionization time-of-flight mass spectrometry.

    Journal of Chromatography A 1155(1):112 (2007) PMID 17481645

    A novel strategy is presented for the fractionation of complex peptide mixtures using two-dimensional planar electrochromatography/thin-layer chromatography (2D PEC/TLC). Phosphopeptides migrate more slowly in the first dimension, based upon their anionic phosphate residues, and certain predomin...
  11. A novel, high-throughput workflow for discovery and identification of serum carrier protein-bound peptide biomarker candidates in ovarian cancer samples.

    Clinical Chemistry 53(6):1067 (2007) PMID 17463175

    Most cases of ovarian cancer are detected at later stages when the 5-year survival is approximately 15%, but 5-year survival approaches 90% when the cancer is detected early (stage I). To use mass spectrometry (MS) of serum proteins for early detection, a seamless workflow is needed that provide...
  12. Phosphopeptide analysis by directly coupling two-dimensional planar electrochromatography/thin-layer chromatography with matrix-assisted laser desorption/ionization time-of-flight mass spectrometry

    Journal of Chromatography A 1155(1):112 (2007)

    A novel strategy is presented for the fractionation of complex peptide mixtures using two-dimensional planar electrochromatography/thin-layer chromatography (2D PEC/TLC). Phosphopeptides migrate more slowly in the first dimension, based upon their anionic phosphate residues, and certain pre...
  13. Performance validation of an improved Xenon-arc lamp-based CCD camera system for multispectral imaging in proteomics.

    Proteomics 5(17):4354 (2005) PMID 16206330

    Advances in gel-based nonradioactive protein expression and PTM detection using fluorophores has served as the impetus for developing analytical instrumentation with improved imaging capabilities. We describe a CCD camera-based imaging instrument, equipped with both a high-pressure Xenon arc lam...
  14. Biomarker discovery and analysis platform: application to Alzheimer's disease.

    BioTechniques 39(4):606 (2005) PMID 16235574

  15. High-resolution serum proteomic profiling of Alzheimer disease samples reveals disease-specific, carrier-protein-bound mass signatures.

    Clinical Chemistry 51(10):1946 (2005) PMID 16081505

    Researchers typically search for disease markers using a "targeted" approach in which a hypothesis about the disease mechanism is tested and experimental results either confirm or disprove the involvement of a particular gene or protein in the disease. Recently, there has been interest in develo...
  16. Housekeeping genes in cancer: normalization of array data.

    BioTechniques 38(5):739 (2005) PMID 15948292

    Biological maintenance of cells under variable conditions should affect gene expression of only certain genes while leaving the rest unchanged. The latter, termed "housekeeping genes," by definition must reflect no change in their expression levels during cell development, treatment, or disease ...
  17. Microscale fractionation facilitates detection of differentially expressed proteins in Alzheimer's disease brain samples.

    Electrophoresis 25(15):2557 (2004) PMID 15300776

    Fractionation enhances the resolution of proteins with similar characteristics by reducing the number of proteins that comigrate in gels, thus facilitating the detection of lower-abundance proteins and the accurate determination of quantitative and qualitative differences in disease and normal s...
  18. Proteomic Analysis of Mitochondrial Proteins

    International Review of Neurobiology 61:31 (2004)

    The chapter discusses the proteomic analysis of mitochondrial proteins. Mitochondria play a central role in multiple cellular processes. In addition, mitochondrial dysfunction has been implicated in the cause of numerous diseases and disorders, including defects in energy metabolism, a...
  19. Proteomic analysis of mitochondrial proteins.

    International Review of Neurobiology 61:31 (2004) PMID 15482810

  20. High-content proteomics: fluorescence multiplexing using an integrated, high-sensitivity, multiwavelength charge-coupled device imaging system.

    Proteomics 3(7):1109 (2003) PMID 12872212

    The detection of proteins in 2-D gels and their subsequent identification by MS is still the "gold standard" in proteomics. Fluorescent detection has increasingly replaced colorimetric and radiometric detection on gels and blots. The reasons for this are multiple and varied and include higher se...