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 Vetmedica, Inc.

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
Rohan Patel
Scientist I, MedImmune, A member of the AstraZeneca Group
Bud Bartlett
Director, Procurement and Sourcing, Alkermes plc
Keith Peden, PhD
Supervisory Research Microbiologist, FDA CBER
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
Alissa M. Resch, PhD
Chief Scientific Officer; Principal Investigator, NHGRI Sample Repository for Human Genetic Research
Coriell Institute for Medical Research
Balasubramanian Ramanathan, PhD
Senior Scientist, Material Sciences, Large Molecule Value Stream, Biotherapeutics Discovery,
Product Development & Supply, Janssen Pharmaceuticals, Inc.
Andrew Blakinger
Manager, Extractables & Leachables Testing, Eurofins Lancaster Laboratories, Inc.
Pauline Smidt
Principal Scientist, Just Biotherapeutics, Inc.
Christopher Korch, PhD
Assistant Clinical Professor, Medicine-Medical Oncology, University of Colorado School of Medicine
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.
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.
Pia Darker
Global Senior Product Manager, Thermo Fisher Scientific
Frederic Girard
Managing Director, Eurofins Spinnovation Analytical
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.
Xiaolin Zhang, PhD
Senior Scientist, Merck & Co., Inc.
Allen L. Burgenson
Global Subject Matter Expert – Testing Solutions, Lonza Walkersville, Inc.
Jean Qiu, PhD
Chief Technology Officer, Founder, Nexcelom Bioscience LLC
S. Steve Zhou, PhD
Director, Virology and Molecular Biology, MicroBioTest, div. of Microbac Laboratories, Inc.
Michael Brewer
Director, Pharmaceutical Analytics, Thermo Fisher Scientific
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
Antonio J. Scatena
Sr. Sales Representative, Gateway Analytical LLC
Kelvin G.M. Brockbank, PhD
CEO, Tissue Testing Technologies LLC
John Bushey
Research Associate, Seattle Genetics, Inc.
Jeffrey Ly
Associate Principal Scientist, Merck & Co., Inc.
Elizabeth C. Dodson
BD Biosciences
Chris Grinnell
Biogen