The Waterside Conference

Speakers

  • 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

  • Pauline Smidt

    Principal Scientist

    Just Biotherapeutics, Inc.

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

  • 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

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

  • 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

    A Quality by Design Approach 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)

    Best Practices and International Standards for Cell Banking

  • Frederic Girard, PhD

    Managing Director

    Eurofins Spinnovation Analytical

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

  • Jean Qiu, PhD

    Chief Technology Officer, Founder

    Nexcelom Bioscience LLC

    High-Speed and High-Throughput Image Cytometry Assays to Investigate CRISPR/Cas9-Mediated Site-Specific Gene Expression, Cell Cycle, Apoptosis, and Reactive Oxygen Species in CHO Cells

  • Chris Grinnell

    Associate Scientist III, Materials Science

    Biogen

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

  • Kathryn Aron, PhD

    Group Leader, Upstream Process Development

    Bristol-Myers Squibb Company

    Implementation of an Integrated Approach for Fingerprinting Cell Culture Media

  • Donna M. Altamuro

    Associate Director, Biobanking Logistics & Customer Support

    Coriell Institute for Medical Research

    Legacy Challenges of the Modern Biobank

  • Michael Brewer

    Director, Global Principal Consultant, Regulatory, BioProduction

    Thermo Fisher Scientific

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

  • S. Steve Zhou, PhD

    Director, Virology and Toxicology, Life Sciences

    Microbac Laboratories, Inc.

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

  • 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

  • Kelvin G.M. Brockbank, PhD

    CEO

    Tissue Testing Technologies LLC

    Nanowarming of Thin and Thick Walled Arteries in 30–50 mL Volumes — The First Step Towards Organ Cryopreservation

  • Rohan Patel

    Scientist, Biopharmaceutical Development, Cell Culture & Fermentation Sciences

    MedImmune, A member of the AstraZeneca Group

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

  • Anissa Cheung

    Regulatory Coordinator. Division of Viral Products, OVRR

    FDA CBER

    Regulatory Considerations for Characterizing Cell Substrates

  • Miguel Sena Esteves, PhD

    Associate Professor, Department of Neurology, Horae Gene Therapy Center

    University of Massachusetts Medical School

    AAV Gene Therapy for Tay-Sachs Disease: Lessons Learned from Preclinical to Clinical Vector Production for an Expanded Access Clinical Trial

  • Jessica Maier

    Scientist I – Process Science

    Boehringer Ingelheim Corporation

    Seed Train Intensification with High Density Cell Banks and N-1 Perfusion

  • Xiaoming "Shawn" He, PhD

    Professor, Fischell Department of Bioengineering

    University of Maryland

    Multiscale Technologies for Enhancing Cryopreservation

  • Michael Burdick, PhD

    Associate Director, Global Pathogen Safety Support

    CSL Behring

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

  • Keith Peden, PhD

    Chief, Laboratory of DNA Viruses

    FDA CBER

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

  • Sonia Houghton

    Chief Executive Officer & Founder

    Cryosphere Services

    The Zeitgeist of Our Time: Reagent Quality is the Cornerstone of Research Excellence

  • 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

  • Linda Fröderberg Roth, PhD

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

    AstraZeneca R&D

    Cell Banking — A Requirement in Pharmaceutical Research

  • Haruhiko Murata, MD, PhD

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

    FDA CBER

    Utility of Basement Membrane Extract in the Evaluation of Tumorigenicity Associated with Vaccine Cell Substrates

  • Elena Bolchakova

    Sr. Staff Scientist

    Thermo Fisher Scientific

    Detection of Viral Contamination in Cell Culture by Targeted Amplicon Sequencing Using an Automated Next-Generation Sequencing Workflow with Simplified Data Analysis

  • Allen L. Burgenson

    Global Subject Matter Expert – Testing Solutions

    Lonza Walkersville, Inc.

    Beyond LAL: The rFC and MAT Assays

  • Elizabeth Turner Gillies, PhD

    Scientist

    American Type Culture Collection (ATCC)

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

  • Mark F. Witcher, PhD

    Senior Consultant

    Brevitas Consulting Inc.

    Developing and Validating Manufacturing Processes for 21st Century Biopharmaceutical Products

  • Chaya M. Kataru, PhD

    Global R&D Director, Cell Nutrition

    Kerry Bio-Science

    Raw Material Variability in Hydrolysates — Room For Improvement?

  • Stefan Yohe, PhD

    Principal Material Science Engineer

    Genentech, a Member of the Roche Group

    New Approaches to Advancing a Raw Material Variability Strategy

  • Mike Ford

    Pilot Development Engineer

    Biogen

    Continuous Manufacturing from Perfusion to Capture Step

  • Biobanking Pluripotent Stem Cells for Research, Diagnostics, and Therapy

  • John J. Li, PhD

    Staff Scientist, Life Sciences Solutions, Bioproduction

    Thermo Fisher Scientific

    Viral Clearance and Aggregate Polish for Clinical Monoclonal Antibodies Using Hydrophobic Interaction Chromatography

  • 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

  • Aaron C. Mack

    Senior Engineer I, Manufacturing Sciences

    Biogen

    Impact of Raw Material Variability on Gene Therapy Modalities

  • Jyoti Velayudhan, PhD

    Associate Director

    Seattle Genetics, Inc.

    Potency Assay Basics and Application to Process Development

  • Sherri Dolan

    Global Technology Consultant - Virus Clearance

    Sartorius Stedim North America Inc.

    Robust Parvovirus (MVM) Clearance Using Anion Exchange Membrane Adsorbers

  • Keith L. Carson

    Founder and Content Chair

    ISBioTech

    Reference Materials for Viral Gene Vectors

  • Raymond Nims, PhD

    Senior Consultant

    RMC Pharmaceutical Solutions, Inc.

    Efficacy of Microbicides for Inactivation of Ebola-Makona Virus in an Organic Load

  • John Bushey

    Research Associate III

    Seattle Genetics, Inc.

    Ensuring Bioreactor Scale-Down Models are Representative of Clinical and Commercial-Scale with Respect to Misincorporations

  • John M. Smith, PhD

    Principal Scientist, Cell and Molecular Biology Method Development and Validation

    Eurofins Lancaster Laboratories, Inc.

    Jacob Serfass, PhD

    Senior Scientist

    Eurofins Lancaster Laboratories, Inc.

    Scientific Considerations for the Analysis of Host Cell Proteins