Hongping Ye

Summary

Affiliation: Food and Drug Administration
Country: USA

Publications

  1. doi request reprint Direct approach for qualitative and quantitative characterization of glycoproteins using tandem mass tags and an LTQ Orbitrap XL electron transfer dissociation hybrid mass spectrometer
    Hongping Ye
    U S Food and Drug Administration, CDER, DPA, St Louis, Missouri 63101, United States
    Anal Chem 85:1531-9. 2013
  2. pmc Detection of protein modifications and counterfeit protein pharmaceuticals using isotope tags for relative and absolute quantification and matrix-assisted laser desorption/ionization tandem time-of-flight mass spectrometry: studies of insulins
    Hongping Ye
    US Food and Drug Administration, Center for Drug Evaluation and Research, Division of Pharmaceutical Analysis, St Louis, MO 63101, USA
    Anal Biochem 379:182-91. 2008
  3. doi request reprint Qualitative and quantitative comparison of brand name and generic protein pharmaceuticals using isotope tags for relative and absolute quantification and matrix-assisted laser desorption/ionization tandem time-of-flight mass spectrometry
    Hongping Ye
    U S Food and Drug Administration, Center for Drug Evaluation and Research, Division of Pharmaceutical Analysis DPA, St Louis, MO 63101, USA
    Anal Biochem 400:46-55. 2010
  4. ncbi request reprint Characterization of currently marketed heparin products: key tests for LMWH quality assurance
    Hongping Ye
    Food and Drug Administration, CDER, Division of Pharmaceutical Analysis, St Louis, MO 63101, USA
    J Pharm Biomed Anal 85:99-107. 2013
  5. doi request reprint Characterization of currently marketed heparin products: analysis of molecular weight and heparinase-I digest patterns
    Cynthia D Sommers
    Division of Pharmaceutical Analysis, CDER, Food and Drug Administration, 1114 Market St Rm 1002, St Louis, MO 63101, USA
    Anal Bioanal Chem 401:2445-54. 2011
  6. doi request reprint Characterization of currently marketed heparin products: key tests for quality assurance
    David A Keire
    Division of Pharmaceutical Analysis, Food and Drug Administration, CDER, 1114 Market St, St Louis, MO 63101, USA
    Anal Bioanal Chem 399:581-91. 2011
  7. doi request reprint Assay of possible economically motivated additives or native impurities levels in heparin by 1H NMR, SAX-HPLC, and anticoagulation time approaches
    David A Keire
    Food and Drug Administration, Division of Pharmaceutical Analysis, 1114 Market St, St Louis, MO 63101, USA
    J Pharm Biomed Anal 52:656-64. 2010
  8. ncbi request reprint Simultaneous determination of protein aggregation, degradation, and absolute molecular weight by size exclusion chromatography-multiangle laser light scattering
    Hongping Ye
    Division of Pharmaceutical Analysis, Food and Drug Administration, 1114 Market Street, Room 1002, St Louis, MO 63101, USA
    Anal Biochem 356:76-85. 2006

Collaborators

Detail Information

Publications8

  1. doi request reprint Direct approach for qualitative and quantitative characterization of glycoproteins using tandem mass tags and an LTQ Orbitrap XL electron transfer dissociation hybrid mass spectrometer
    Hongping Ye
    U S Food and Drug Administration, CDER, DPA, St Louis, Missouri 63101, United States
    Anal Chem 85:1531-9. 2013
    ..This method can be used as a qualitative and quantitative technique for direct characterization of glycoproteins and has applicability for detection of counterfeit glycoprotein drug products...
  2. pmc Detection of protein modifications and counterfeit protein pharmaceuticals using isotope tags for relative and absolute quantification and matrix-assisted laser desorption/ionization tandem time-of-flight mass spectrometry: studies of insulins
    Hongping Ye
    US Food and Drug Administration, Center for Drug Evaluation and Research, Division of Pharmaceutical Analysis, St Louis, MO 63101, USA
    Anal Biochem 379:182-91. 2008
    ..Collectively, the iTRAQ method can be used as a qualitative and quantitative technique for the detection of protein modification and counterfeiting...
  3. doi request reprint Qualitative and quantitative comparison of brand name and generic protein pharmaceuticals using isotope tags for relative and absolute quantification and matrix-assisted laser desorption/ionization tandem time-of-flight mass spectrometry
    Hongping Ye
    U S Food and Drug Administration, Center for Drug Evaluation and Research, Division of Pharmaceutical Analysis DPA, St Louis, MO 63101, USA
    Anal Biochem 400:46-55. 2010
    ..The iTRAQ and global internal standard technology (GIST) methods were compared, and the iTRAQ method provided both higher sequence coverage and enhanced signal intensity...
  4. ncbi request reprint Characterization of currently marketed heparin products: key tests for LMWH quality assurance
    Hongping Ye
    Food and Drug Administration, CDER, Division of Pharmaceutical Analysis, St Louis, MO 63101, USA
    J Pharm Biomed Anal 85:99-107. 2013
    ..In addition, innovator and generic versions of formulated enoxaparin products purchased in 2011 are compared using these tests and found to be highly similar within the discriminating power of the assays applied...
  5. doi request reprint Characterization of currently marketed heparin products: analysis of molecular weight and heparinase-I digest patterns
    Cynthia D Sommers
    Division of Pharmaceutical Analysis, CDER, Food and Drug Administration, 1114 Market St Rm 1002, St Louis, MO 63101, USA
    Anal Bioanal Chem 401:2445-54. 2011
    ..In addition, we found that the PAGE analysis of heparinase digested UFH and neat LMWH samples yield characteristic patterns that provide a facile approach for identification and assessment of drug quality and uniformity...
  6. doi request reprint Characterization of currently marketed heparin products: key tests for quality assurance
    David A Keire
    Division of Pharmaceutical Analysis, Food and Drug Administration, CDER, 1114 Market St, St Louis, MO 63101, USA
    Anal Bioanal Chem 399:581-91. 2011
    ....
  7. doi request reprint Assay of possible economically motivated additives or native impurities levels in heparin by 1H NMR, SAX-HPLC, and anticoagulation time approaches
    David A Keire
    Food and Drug Administration, Division of Pharmaceutical Analysis, 1114 Market St, St Louis, MO 63101, USA
    J Pharm Biomed Anal 52:656-64. 2010
    ..9 specification value in samples spiked at ca. weight percent of 15% or greater of OSCS. We conclude that the SAX-HPLC assay is the most sensitive and robust assay to identify and quantitate possible GAG-based EMAs in heparin...
  8. ncbi request reprint Simultaneous determination of protein aggregation, degradation, and absolute molecular weight by size exclusion chromatography-multiangle laser light scattering
    Hongping Ye
    Division of Pharmaceutical Analysis, Food and Drug Administration, 1114 Market Street, Room 1002, St Louis, MO 63101, USA
    Anal Biochem 356:76-85. 2006
    ..This technique is valuable not only for assessing the extent of aggregation but also for effectively monitoring molecule degradation as evidenced by molecular weight reduction and change in monomer amount...