Search Results - "McGivney, James B"

Capillary zone electrophoresis tandem mass spectrometry detects low concentration host cell impurities in monoclonal antibodies by Zhu, Guijie, Sun, Liangliang, Heidbrink‐Thompson, Jennifer, Kuntumalla, Srilatha, Lin, Hung‐yu, Larkin, Christopher J, McGivney, James B., IV, Dovichi, Norman J

“…We have evaluated CZE‐ESI‐MS/MS for detection of trace amounts of host cell protein impurities in recombinant therapeutics. Compared to previously published…”
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Analytical characterization of full, intermediate, and empty AAV capsids by McColl-Carboni, Aisleen, Dollive, Serena, Laughlin, Sarah, Lushi, Rudenc, MacArthur, Michael, Zhou, Shanshan, Gagnon, Jeffrey, Smith, Christopher A., Burnham, Brenda, Horton, Robert, Lata, Dimpal, Uga, Brianna, Natu, Kalyani, Michel, Emmanuela, Slater, Celia, DaSilva, Evan, Bruccoleri, Robert, Kelly, Tim, McGivney, James B.

“…Manufacturing of recombinant adeno-associated virus (AAV) vectors produces three types of capsids: full, intermediate, and empty. While there are different…”
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A rapid cIEF–ESI–MS/MS method for host cell protein analysis of a recombinant human monoclonal antibody by Zhu, Guijie, Sun, Liangliang, Wojcik, Roza, Kernaghan, Dawn, McGivney, James B., Dovichi, Norman J.

“…A rapid and reproducible system that couples capillary isoelectric focusing to a high-resolution mass spectrometer was developed for on-line analysis and…”
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Absolute quantitation of host cell proteins in recombinant human monoclonal antibodies with an automated CZE-ESI-MS/MS system by Zhu, Guijie, Sun, Liangliang, Linkous, Travis, Kernaghan, Dawn, McGivney IV, James B., Dovichi, Norman J.

“…We report the first use of CZE for absolute characterization of host cell proteins (HCPs) in recombinant human monoclonal antibodies. An electrokinetically…”
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Quantitative analysis of the supernatant from host and transfected CHO cells using iTRAQ 8-plex technique by Zhu, Guijie, Sun, Liangliang, Albanetti, Thomas, Linkous, Travis, Larkin, Christopher, Schoner, Ronald, McGivney IV, James B., Dovichi, Norman J.

“…ABSTRACT We employed UPLC‐MS/MS with iTRAQ 8‐plex labeling to quantitatively analyze the supernatant produced by two Chinese hamster ovary (CHO) cell lines…”
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Comprehensive analysis of host cell impurities in monoclonal antibodies with improved sensitivity by capillary zone electrophoresis mass spectrometry by Zhang, Zhenbin, Albanetti, Thomas, Linkous, Travis, Larkin, Christopher J., Schoner, Ronald, McGivney, James B., Dovichi, Norman J

“…Four methods were compared for analysis of host‐cell protein (HCP) impurities in a recombinant mAb. First, CZE‐MS/MS was used to analyze the digest of an HCP…”
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Strategy for Generating Sequence-Defined Aptamer Reagent Sets for Detecting Protein Contaminants in Biotherapeutics by McGivney, James B, Csordas, Andrew T, Walker, Faye M, Bagley, Elizabeth R, Gruber, Emily M, Mage, Peter L, Casas-Finet, Jose, Nakamoto, Margaret A, Eisenstein, Michael, Larkin, Christopher J, Strouse, Robert J, Soh, H. Tom

“…Biologic drugs are typically manufactured in mammalian host cells, and it is critical from a drug safety and efficacy perspective to detect and remove host…”
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Rapid Identification of Biotherapeutics with Label-Free Raman Spectroscopy by Paidi, Santosh Kumar, Siddhanta, Soumik, Strouse, Robert, McGivney, James B, Larkin, Christopher, Barman, Ishan

“…Product identification is a critical and required analysis for biotheraputics. In addition to regulatory requirements for identity testing on final drug…”
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Evaluation of a synthetic peptide as a replacement for the recombinant fusion protein of respiratory syncytial virus in a potency ELISA by McGivney, James B., Bishop, Eric, Miller, Kenneth, Casas-Finet, Jose, Yang, Harry, Wei, Ziping, Strouse, Robert, Schenerman, Mark

“…This report describes the development of a potency ELISA using a peptide derived from the motavizumab binding epitope of respiratory syncytial virus (RSV)…”
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