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Well Characterized Biologics & Biological Assays
September 2023
Boston, MA
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Key Sessions
Darryl Davis, Ph.D.
KEYNOTE ADDRESS: Structural Mass Spectroscopy: Where, When and Why?
Astrazeneca
Stephen Krause, PhD
KEYNOTE ADDRESS: Commercial Analytical Method Lifecycle Management and the Concept of a Reference Laboratory for Autologous Cell Therapies
Bristol Myers Squibb
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Day One - EST/EDT (Eastern Daylight, GMT-4)

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Day One - EST/EDT (Eastern Daylight, GMT-4)

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7:00am - 8:00am60 mins
General Session
Registration, Coffee and Breakfast Bakeries
    8:00am - 8:10am10 mins
    General Session
    Chairperson's Welcome and Opening Remarks
    • Elisabeth Krug - Executive Director, Eli Lilly & Company
    8:10am - 8:45am35 mins
    General Session
    KEYNOTE ADDRESS: Structural Mass Spectroscopy: Where, When and Why?
    • Darryl Davis, Ph.D. - Senior Director, Astrazeneca
    8:45am - 9:15am30 mins
    General Session
    CE-MS Method Development for mAb Charge Heterogeneity Characterization
    • Kristin Schultz Kuszak - Associate Director, Astrazeneca
    9:15am - 9:45am30 mins
    General Session
    Identification and Functional Characterization of Novel Charge Variant in a Monoclonal Antibody
    • Yi Yang, Ph.D. - Senior Scientist, Protein Chemistry Group, Genentech Inc
    9:45am - 10:15am30 mins
    General Session
    Networking Refreshment Break in the Poster & Exhibit Hall
      10:15am - 10:45am30 mins
      General Session
      ADCC Enhancement of Rituximab Through a Non-Invasive Approach: Anti-Oxidant Treatment
      • Aditya Narvekar - PhD, Department of Pharmaceutical Sciences and Technology, Institute of Chemical Technology
      10:45am - 11:15am30 mins
      General Session
      C-Terminal Lysine Processing of IgG in Human Subcutaneous Space
      • Michael Kim, PhD - Technical Development Scientist, Protein Analytical Chemistry, Genentech
      11:15am - 11:45am30 mins
      General Session
      Physicochemical Characterization of Antibodies in Undiluted High-Concentrated Drug Product Solutions and in Concentrations Used in the Clinic – Comparison of the Originator Bevacizumab with a Biosimilar Candidate
      • Tudor Arvinte, Ph.D. - Professor / CEO, University of Geneva Switzerland / Therapeomic Inc.
      11:45am - 12:15pm30 mins
      General Session
      Accelerating Potency Bioassays Implementation from Development to QC Lot-Release & Ensuring Long-Term Assay Reproducibility
      • Alpana Prasad, PhD - Director of Innovations and Strategic Partnerships, Eurofins DiscoverX
      12:15pm - 12:30pm15 mins
      General Session
      Luncheon in the Poster & Exhibit Hall
        12:30pm - 1:00pm30 mins
        General Session
        LUNCHEON PRESENTATION: Characterisation of Disulphide Bond Status for Biotherapeutic Proteins
        • Michael Walker, PhD - Technical Expert, LC-MS Protein Analysis, Intertek Pharmaceutical Services
        1:00pm - 1:25pm25 mins
        General Session
        Luncheon in the Poster & Exhibit Hall
          1:25pm - 1:30pm5 mins
          General Session
          Chairperson's Remarks
          • Nadine Ritter, Ph.D. - President and Analytical Advisor, Global Biotech Experts, LLC
          1:30pm - 2:00pm30 mins
          General Session
          Target, Accelerated, Stress Stability and Forced Degradation Studies: A CMC Gift that Keeps on Giving
          • Nadine Ritter, Ph.D. - President and Analytical Advisor, Global Biotech Experts, LLC
          2:00pm - 2:30pm30 mins
          General Session
          Piloting a Flight for the Long Haul – Method Validation Across a Biopharmaceutical's Lifecycle
          • Greg Adams, Ph.D. - Senior Director, Global Analytical Strategy & Development, FUJIFILM Diosynth Biotechnologies
          2:30pm - 3:00pm30 mins
          General Session
          Regulatory Approaches to Accelerated Development of SARS-CoV Neutralizing Antibodies
          • Maria-Teresa Gutierrez - CDER, US FDA
          3:00pm - 3:30pm30 mins
          General Session
          Networking Refreshment Break in the Poster & Exhibit Hall
            3:30pm - 4:00pm30 mins
            General Session
            Development of Modern Vaccines
            • Pepijn Burgers - Associate Scientific Director, The Janssen Pharmaceutical Companies of Johnson & Johnson
            4:00pm - 4:30pm30 mins
            General Session
            Analytical Characterization and Method Validation for a Novel Format PEGylated Antibody
            • Holly Yip - Senior Research Associate, Protein Analytical Chemistry, Process Development, Genentech
            4:30pm - 5:00pm30 mins
            General Session
            Comprehensive Characterization of a Bispecific T-cell Redirector with Multiple Technologies, CE, iCIEF-MS and Novel Alternative Fragmentation
            • Kristen Nields - Senior Scientist, The Janssen Pharmaceutical Companies of Johnson & Johnson
            5:00pm - 5:30pm30 mins
            General Session
            KEYNOTE ADDRESS: Commercial Analytical Method Lifecycle Management and the Concept of a Reference Laboratory for Autologous Cell Therapies
            • Stephen Krause, PhD - Executive Director, Analytical Science and Technology, Cell Therapy Quality, Bristol Myers Squibb
            5:30pm - 6:00pm30 mins
            General Session
            Reimaging Biologics Sample Analysis
            • Peter Johnson, Ph.D. - Manager, Field Applications Science, Bio-Techne
            6:00pm - 7:30pm90 mins
            General Session
            Cocktail Reception in the Poster & Exhibit Hall
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