The Waterside Conference


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Speakers

  • John M. Baust, PhD

    President, Founder, and Lead Scientist

    CPSI Biotech

    Next-Generation Strategies for Enhanced Cryopreservation Outcome

  • Serge Monpoeho, PhD

    Sr. Director QC & Chief Virologist

    Regeneron Pharmaceuticals, Inc.

    Atypical False Positive Observed During In Vitro Virus Assay for MAb Adventitious Virus Screening

  • Simon Joubert, PhD

    Team Leader, Cell Line Development, Life Sciences - Human Health Therapeutics Research Center

    National Research Council Canada (NRC)

    High-Throughput Screening of High-Producing CHO Cell Lines for Biomanufacturing of Biologics

  • Janike Ehret

    Scientist – Advanced Cell Culture Technologies, Life Science, Upstream R&D

    Merck KGaA

    Innovative Molecules to Simplify Fed-Batch Processes and Ensure Batch-to-Batch Consistency

  • Xiaolin Zhang, PhD

    Senior Scientist

    Merck & Co., Inc.

    Feeding TCA Cycle Intermediates Improves Lactate Consumption and Antibody Production in CHO Cell Cultures

  • Glenn A. Harris, PhD

    Director - Integrated Life Sciences Platforms

    908 Devices Inc.

    Analysis of Cell Media Degradation and Variations With a New At-Line Analyzer

  • Susan Burke, PhD

    Director Process Development, Materials Science

    Amgen Inc.

    Application of Data Analytics to Better Understand and Control Raw Material Variation

  • Harika Vemula, PhD

    Senior Scientist, Upstream R&D

    Merck KGaA

    Cell Culture Media Characterization as a Quality by Design (QbD) Tool to Assess Critical Raw Materials

  • Elizabeth C. Dodson

    Senior Manager, R&D

    Thermo Fisher Scientific

    Analytical Insights from Raw Material Testing of Cell Culture Media Components

  • Christopher Korch, PhD

    Assistant Clinical Professor, Medicine-Medical Oncology

    University of Colorado School of Medicine

    Imposter Cell Lines – A Continuing Threat to the Validity of Biomedical Research

  • Jeffrey Ly

    Associate Principal Scientist

    Merck & Co., Inc.

    Investigating Atypical Cell Culture Performance and Charge Variant Profile of a Monoclonal Antibody from a Large-Scale Mammalian Cell Culture Process

  • Charles E. Ducker, PhD

    Principal Chemist/Group Leader, Extractables and Leachables

    Eurofins Lancaster Laboratories, Inc.

    Best Practices for Planning and Conducting Extractable and Leachable Studies

  • Jamie Almeida

    Research Biologist, Biochemical Science Division, Bioassay Methods Group

    National Institute of Standards & Technology (NIST)

    Development of an Allelic Ladder for Mouse Cell Line Authentication

  • Li Zhang

    Process Development Senior Scientist

    Amgen Inc.

    Use of Stable Pools for Drug Substance Production to Support Non-Clinical Studies to Accelerate the Timeline – A Case Study

  • Balasubramanian Ramanathan, PhD

    Senior Scientist, Material Sciences, Large Molecule Value Stream, Biotherapeutics Discovery, Product Development & Supply

    Janssen Pharmaceuticals, Inc.

    Industry-Wide Benchmarking on Standardization of Trace Elements in Cell Culture Media

  • Fang Tian, PhD

    Lead Scientist, Cell Biology Group Leader, ATCC Cell Systems

    American Type Culture Collection (ATCC)

    Precision Genome Engineering of Mammalian Host Cell Lines for Enhanced Viral Production

  • Frederic Girard, PhD

    Managing Director

    Eurofins Spinnovation Analytical

    Complex Raw Material and Spent Cell Media Analyses to Support Bioprocess Development and Troubleshooting Activities

  • Chris Grinnell

    Associate Scientist III, Materials Science

    Biogen

    Elemental Metal Variance in Cell Culture Raw Materials: Analytical Method Design and Application

  • Sheldon Mink, PhD

    Associate Director QC Virology

    Regeneron Pharmaceuticals, Inc.

    Background NGS Data for Sample Matrix and Reference Control Standards Using Nanopore Sequencing

  • Kathryn Aron, PhD

    Group Leader, Upstream Process Development

    Bristol-Myers Squibb Company

    Implementation of an Integrated Approach for Fingerprinting Cell Culture Media

  • Matthias Brunner, PhD

    Senior Scientist

    Boehringer Ingelheim GmbH

    From Chemically to Functionally Defined: A Development Strategy to Reduce Raw Material Introduced Process Variability in Cell Culture Media

  • Sally Kline, PhD

    Head of Materials Science

    Genentech, a Member of the Roche Group

    New Approaches to Advancing a Raw Material Variability Strategy

  • Xiaoxi Wei, PhD

    Founder & CEO

    X-Therma Inc.

    A Nature Inspired DMSO-, Protein-, and Serum-Free Chemically-Defined Biopreservation Solution, the New Horizon of Precision in Cell Manufacturing and Processing

  • S. Steve Zhou, PhD

    Director, Virology and Toxicology

    MicroBioTest, div. of Microbac Laboratories, Inc.

    Surface Decontamination: Removal or Inactivation? Spray, Wipe, or Vapor?

  • Aaron C. Mack

    Senior Engineer, Materials Science

    Biogen

    Impact of Raw Material Variability on Cell and Gene Therapy Modalities

  • Pauline Smidt

    Principal Scientist

    Just Biotherapeutics, Inc.

    Utilizing High-Throughput Stable Transfections to Eliminate Transient Transfections for Sequence Variant Analysis

  • Allen L. Burgenson

    Global Subject Matter Expert – Testing Solutions

    Lonza Walkersville, Inc.

    Beyond LAL: rFC and MAT

  • Keith Peden, PhD

    Supervisory Research Microbiologist

    FDA CBER

    Facilitating the Introduction of New Vaccines: Addressing DNA Oncogenicity Concerns with Novel Cell Substrates

  • CHO Cell Culture Process Optimization at Low Glucose Concentrations for mAB Production

  • Phillip W. Berman, PhD

    Distinguished Research Professor, Department of Biomolecular Engineering

    University of California, Santa Cruz

    Gene Editing to Improve Upstream and Downstream Production of HIV Vaccines

  • Michael Brewer

    Director, Pharmaceutical Analytics, Life Technologies Brand; Applied Biosystems Products

    Thermo Fisher Scientific

    Update on Validation Considerations for Rapid Mycoplasma Detection Using qPCR: Regulatory Queries and Responses

  • Kelvin G.M. Brockbank, PhD

    CEO

    Tissue Testing Technologies LLC

    Ice-Free Cryopreservation of Tissues and Nanowarming Employing Fe Nanoparticles and Inductive Heating

  • Jessica Maier

    Senior Scientist

    Boehringer Ingelheim Corporation

    Seed Train Intensification Using Perfusion Waves

  • Haruhiko Murata, MD, PhD

    Research Biologist (PI), Division of Viral Products, Office of Vaccines Research and Review

    FDA CBER

    Tumorigenicity Characterization of Cells

  • James Lambropoulos

    Sr. Engineer I, Proteins/Cell Culture Development

    Biogen

    Get Off the Critical Path: Long-Term Cell Banking Strategies and Working with Fast Timelines

  • Linda Roth, PhD

    Team Leader, Cell Bank SE, R&D, Innovative Medicines, Discovery Sciences

    AstraZeneca R&D

    Industry Cell Banking Management

  • Michael Burdick, PhD

    Associate Director, Global Pathogen Safety Support

    CSL Behring

    Facility Segregation for Downstream Processing of Plasma-Derived and Recombinant Products

  • Jyoti Velayudhan, PhD

    Associate Director

    Seattle Genetics, Inc.

  • Marc G. Aucoin, PhD

    Associate Professor, Center for Bioengineering and Biotechnology, Waterloo Institute for Nanotechnology, Department of Chemical Engineering

    University of Waterloo

  • Bud Bartlett

    Director, Procurement and Sourcing

    Alkermes plc

  • Jean Qiu, PhD

    Chief Technology Officer, Founder

    Nexcelom Bioscience LLC

  • Donna M. Altamuro

    Associate Director, Biobanking Logistics & Customer Support

    Coriell Institute for Medical Research

  • John Smith, PhD

    Principal Scientist

    Eurofins Lancaster Laboratories, Inc.

  • John Bushey

    Research Associate III

    Seattle Genetics, Inc.

  • Anissa Cheung

    Regulatory Coordinator. Division of Viral Products, OVRR

    FDA CBER

    Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications

  • Miguel Sena Esteves, PhD

    Associate Professor, Department of Neurology, Horae Gene Therapy Center

    University of Massachusetts Medical School