The Waterside Conference


  • Sponsor:

  • Exhibits:
  • Media Partners:

Expansion & Expression

Chaired By:

Swapnil Bhargava, PhD
Seattle Genetics, Inc.
Daisie Ogawa
Boehringer Ingelheim Corporation

Topics

  • Cloning and Performance Optimization
  • Media and Buffer Development
  • Single-Use Systems and Components
  • Closed Systems
  • Robotics
  • Perfusion, Fed Batch, Batch Processes
  • Feed and Harvest Strategies
  • Managing Metabolites and Dissolved Gases
  • In-Line, At-Line, Off-Line Analysis
  • Continuous Processing
  • Integrating Unit Operations
  • Defining Lots and Release Testing

Contaminant Control

Chaired By:

Jeri Ann Boose, PhD
Eurofins Lancaster Laboratories, Inc.
Raymond Nims, PhD
RMC Pharmaceutical Solutions, Inc.

Topics

  • Host Cell Proteins
  • Host Cell DNA
  • Sterility and Endotoxins
  • Mycoplasma
  • Viral Contaminants and Clearance
  • Rapid Microbial Testing
  • Regulatory Expectations
  • Particulates

Cell Banking & Characterization

Chaired By:

Fang Tian, PhD
American Type Culture Collection (ATCC)
Linda Roth, PhD
AstraZeneca R&D
Haruhiko Murata, MD, PhD
FDA CBER

Topics

  • Cell and Tissue Procurement
  • Cell Line History and Authentication
  • Regulation and Governance
  • Cold Chain Management
  • Cell Bank Management
  • Stability and Characterization
  • Contaminant Identification and Clearance
  • Cryopreservation
  • Cell Line Development

Raw Materials Science & Control

Chaired By:

David Kolwyck
Biogen
Kevin P. Kent, PhD
Boehringer Ingelheim Animal Health

Topics

  • Analytical Technologies for Raw Material Characterization
  • Raw Material Qualification
  • In-House Testing vs. Vendor CoA
  • Tech Transfer
  • Leveraging CDMO for Speed to Clinic
  • Vendor Qualification
  • Product Comparability
  • Use of Standards
  • Purity and Consistency
  • Acceptance Testing
  • Storage and Release Testing
  • Expired Materials

Featured Speakers

Jamie Almeida
Research Biologist, Biochemical Science Division, Bioassay Methods Group, National Institute of Standards & Technology
Development of an Allelic Ladder for Mouse Cell Line Authentication
Rohan Patel
Scientist I, MedImmune, A member of the AstraZeneca Group
CHO Cell Culture Process Optimization at Low Glucose Concentrations for mAB Production
Bud Bartlett
Director, Procurement and Sourcing, Alkermes plc
Keith Peden, PhD
Supervisory Research Microbiologist, FDA CBER
Facilitating the Introduction of New Vaccines: Addressing DNA Oncogenicity Concerns with Novel Cell Substrates
Aaron C. Mack
Engineer III, Materials Science, Biogen
Serge Monpoeho, PhD
Sr. Director QC & Chief Virologist, Regeneron Pharmaceuticals, Inc.
Jyoti Velayudhan, PhD
Associate Director, Seattle Genetics, Inc.
Sally Kline, PhD
Head of Materials Science, Genentech, a Member of the Roche Group
Balasubramanian Ramanathan, PhD
Senior Scientist, Material Sciences, Large Molecule Value Stream, Biotherapeutics Discovery,
Product Development & Supply, Janssen Pharmaceuticals, Inc.
Chuck E. Ducker, PhD
Principal Chemist/Group Leader, Extractables and Leachables, Eurofins Lancaster Laboratories, Inc.
Best Practices for Planning and Conducting Extractable and Leachable Studies
Pauline Smidt
Principal Scientist, Just Biotherapeutics, Inc.
Utilizing High-Throughput Stable Transfections to Eliminate Transient Transfections for Sequence Variant Analysis
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
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
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
Marc G. Aucoin, PhD
Associate Professor, Center for Bioengineering and Biotechnology, Waterloo Institute for Nanotechnology,
Department of Chemical Engineering, University of Waterloo
Xiaoxi Wei
Founder & CEO, X-Therma Inc.
Frederic Girard
Managing Director, Eurofins Spinnovation Analytical
Complex Raw Material and Spent Cell Media Analyses to Support Bioprocess Development and Troubleshooting Activities
Sheldon Mink, PhD
Associate Director QC Virology, Regeneron Pharmaceuticals, Inc.
Phillip Berman, PhD
Distinguished Research Professor, Jack Baskin School of Engineering, University of California, Santa Cruz
Susan Burke, PhD
Director Process Development, Materials Science, Amgen Inc.
Application of Data Analytics to Better Understand and Control Raw Material Variation
Xiaolin Zhang, PhD
Senior Scientist, Merck & Co., Inc.
Feeding TCA Cycle Intermediates Improves Lactate Consumption and Antibody Production in CHO Cell Cultures
Allen L. Burgenson
Global Subject Matter Expert – Testing Solutions, Lonza Walkersville, Inc.
Beyond LAL: rFC and MAT
Simon Joubert, PhD
Team Leader, Cell Line Development, Life Sciences - Human Health Therapeutics Research Center, National Research Council Canada
Glenn A. Harris, PhD
Director - Integrated Life Sciences Platforms, 908 Devices Inc.
Jean Qiu, PhD
Chief Technology Officer, Founder, Nexcelom Bioscience LLC
James Lambropoulos
Engineer, Biopharmaceutical Process Development, Biogen
S. Steve Zhou, PhD
Director, Virology and Toxicology, MicroBioTest, div. of Microbac Laboratories, Inc.
Surface Decontamination: Removal or Inactivation? Spray, Wipe, or Vapor?
Michael Brewer
Director, Pharmaceutical Analytics, Thermo Fisher Scientific
Update on Validation Considerations for Rapid Mycoplasma Detection Using qPCR: Regulatory Queries and Responses
Harika Vemula, PhD
Senior Scientist, Upstream R&D, Merck KGaA
Introduction to a Raw Material Characterization Program and Control Strategy
Andreas Unsöld
Head of Cell Culture Media, Boehringer Ingelheim GmbH
From Chemically to Functionally Defined: A Development Strategy to Reduce Raw Material Introduced Process Variability in Cell Culture Media
Michael Burdick
Associate Director, Global Pathogen Safety Support, CSL Behring
John M. Baust, PhD
President, Founder, and Lead Scientist, CPSI Biotech
Next-Generation Strategies for Enhanced Cryopreservation Outcome
Kelvin G.M. Brockbank, PhD
CEO, Tissue Testing Technologies LLC
Ice-Free Cryopreservation of Tissues and Nanowarming Employing Fe Nanoparticles and Inductive Heating
John Bushey
Research Associate, Seattle Genetics, Inc.
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
John Smith, PhD
Principal Scientist, Eurofins Lancaster Laboratories, Inc.
Elizabeth C. Dodson
Senior Manager, R&D, BD Biosciences
Analytical Insights from Raw Material Testing of Cell Culture Media Components
Jessica Maier
Boehringer Ingelheim Corporation
Seed Train Intensification Using Perfusion Waves
Chris Grinnell
Biogen