Resources
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Analytical Tools for Higher Order Structure Assessment in Comparability and Biosimilarity
Speaker Presentation Jordan Brad Amgen 2018
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Immunogenicity of Protein Aggregates
Speaker Presentation Jiskoot Wim University of Utrecht 2018
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Determination of Interaction Parameters for Reversibly Self-Associating Antibodies: A Comparative Analysis
Speaker Presentation Hopkins Mandi University of Colorado 2018
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Native Peptide Mapping - New Method to Monitor Higher Order Structure Changes in a QC Laboratory
Speaker Presentation Degueldre Michel UCB 2018
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Electron Microscopy Imaging Reveals Unique
Higher Order Structures of Adalimumab-TNFα and Infliximab-TNFα Complexes
Speaker Presentation Chan Siew Leong AbbVie 2018
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Using Automation and Statistical Analysis to Enhance Sensitivity and Reduce Subjectivity of Biological Therapeutic Comparability Using Circular Dichroism
Speaker Presentation Bowsher Leo UCB 2018
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Structural Characterization and Comparability Between a Therapeutic Protein and its Novel Fc Fusion
Counterpart
Speaker Presentation Bou-Assaf George Biogen 2018
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Time‐Resolved Fluorescence Spectroscopy: An Old Technique to Monitor Protein Higher Order Structure Changes
Speaker Presentation Arzhantsev Sergey FDA 2018
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Microfluidic Modulation Spectroscopy of a Biotherapeutic at Low to High Concentrations Without Interference from Formulation Excipients
Speaker Presentation Zonderman Joshua RedShiftBio 2019
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The Use of Small Angle X-ray Scattering for Studying Excipient-Modulated Physical Stability and Viscosity of Monoclonal Antibody Formulations
Speaker Presentation Xu Amy NIST 2019
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The Form and Substance of HOS Studies Used to Support Comparability and Biosimilarity in Biological Drug Submission; A Regulator′s Perspective
Speaker Presentation Tounekti Omar Health Canada 2019
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Compensated Hydroxyl Radical Protein Footprinting: A Flexible, Quantitative Probe of Protein Topography
Speaker Presentation Sharp Joshua University of Mississippi 2019
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Characterization and Biological Relevance of Protein Aggregates and Other Particles 100-20000nm in Size (Submicron and Subvisible)
Speaker Presentation Narhi Linda Amgen 2019
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Beyond Aggregates: Light Scattering Tools for Biophysical Characterization and Quantitation
Speaker Presentation Kenrick Sophia Wyatt 2019
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HOS: The Journey from Characterisation to QC
Speaker Presentation Jone Carl Narwhal Sciences 2019
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Computational Methods for Comparison of NMR Spectra
Speaker Presentation Japelj Bostjan Novartis 2019
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Physicochemical and Immunological Comparison of CRM197 from Different Manufacturers and Expression Systems
Speaker Presentation Hickey John University of Kansas 2019
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Complex Polypeptides: Are Scientific Regulatory Considerations More Aligned to Generics or Biosimilars?
Speaker Presentation Hauda Karen Novo Nordisk 2019
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Structure and Dynamics of a Site-Specific Labeled Human Fc Fragment with Tuned Effector Functions
Speaker Presentation Gallagher Travis NIST 2019
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Kinetic Analysis of the Conformational Stability and Aggregation of mAbs Using Calorimetry
Speaker Presentation Freire Ernesto Johns Hopkins University 2019