The Waterside Conference


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Speakers

  • Emily Schirmer

    Director of Downstream Process Development

    Catalent Pharma Solutions

    Continuous Processing in Biomanufacturing: Case Studies in Biologic Development Scale-Down Models and Manufacturing

  • Edita Botonjic-Sehic, PhD

    Global Process Analytical Technology (PAT) Manager

    Pall Biotech

    Process Analytical Technology (PAT) for Continuous Bioprocessing

  • David Kolwyck

    Director Materials Science

    Biogen

    Bioprocessing Raw Material Characterization and Control Strategy

  • Todd L. Talarico, PhD

    Vice President of Process Development

    Medicago USA

    Investigation of an Adventitious Agent False Positive Test in a Plant-Based Influenza Vaccine

  • Mark Berge

    Principal Scientist

    MedImmune, A member of the AstraZeneca Group

    Understanding the Effect of Preparation Methods on Bioavailability of Components in a Cell Culture Feed

  • Gregory T. Bleck, PhD

    Global Head of R&D, Biologics

    Catalent Pharma Solutions

    Efficient Expression of Complex Proteins in Mammalian Cells

  • Maria M. Bednar, PhD

    Scientist I, AT Virology

    Biogen

    Next-Generation Sequencing Versus Traditional Methods: A New Frontier for Adventitious Virus Detection

  • Yves Durocher, PhD

    Section Head, Mammalian Cell Expression - Human Health Therapeutics Research Center

    National Research Council Canada

    The Cumate-Inducible Switch for Stable CHO Pool and Clone Generation

  • Lisa M. Dixon, DVM

    Director, Animal Product Imports

    USDA APHIS

    Bovine Serum Import Policy Overview, Updates, and APHIS’ Response When Serum Fails Safety Testing

  • Barry Rosenblatt, PhD

    President

    SME Biotech Consulting

    Development, Automation, and Qualification of Scale-Down Models for Protein Production and Purification

  • Stephen Stoltzfus

    Principal Scientist / Group Leader, Viral Safety and Clearance Services

    Eurofins Lancaster Laboratories, Inc.

    Pitfalls of Viral Clearance Studies

  • John M. Baust, PhD

    President, Founder, and Lead Scientist

    CPSI Biotech

    Strategies and Trends for Improving Sample Quality Following Cryopreservation

  • Robert R. Boulanger, PhD

    Process Specialist

    CRB

    Process Analysis and Automation

  • S. Steve Zhou, PhD

    Director, Virology and Molecular Biology

    MicroBioTest, div. of Microbac Laboratories, Inc.

    Contamination Control in Biomanufacturing: From Monitoring to Disinfection

  • Allen L. Burgenson

    Global Subject Matter Expert – Testing Solutions

    Lonza Walkersville, Inc.

    Low Endotoxin Recovery (LER): the Good, the Bad, and the Ugly

  • Michael Brewer

    Director, Pharmaceutical Analytics

    Thermo Fisher Scientific

    Detection of Adventitious Agents in CHO Cell Cultures Using Ultra-High Multiplex PCR and Next-Generation Sequencing

  • Serge Monpoeho, PhD

    Sr. Director QC & Chief Virologist

    Regeneron Pharmaceuticals, Inc.

    Approach to Pre- and Post-Viral Clearance Room Segregation

  • Dayue Chen, PhD

    Microbiology and Molecular Analytics, Bioprocess Research and Development

    Eli Lilly & Company

    MMV Inactivation by HTST: Beyond the Log10 Reduction Factors

  • Balsam Shawky

    Senior R&D Biologist, Cell Authentication

    American Type Culture Collection (ATCC)

    An Update on CO1 Multiplex PCR and Barcode Sequencing Analysis for Species Identification

  • Matthew Hammond, PhD

    Process Development Principal Scientist

    Amgen Inc.

    Establishing an Attribute-Focused Approach to Raw Materials

  • Andreas Unsöld

    Head of Cell Culture Media

    Boehringer Ingelheim GmbH

    Spectroscopic Online Monitoring Methods to Identify the Impact of Preparation Parameters and Raw Materials on Chemically Defined Cell Culture Media Quality

  • Michael Burdick, PhD

    Associate Director, Global Pathogen Safety Support

    CSL Behring

    Development of an Efficient Hepatitis E Virus Cell Culture Infectivity Assay for Evaluating the Clearance Capacity of Biological Manufacturing Processes

  • Christopher Canova

    Associate Scientist, DPDS, Biotherapeutics Development/API-LM

    Janssen Research & Development, LLC

    Reduced Scale Model Qualification Using Multivariate Visualization & Bayesian Inferential Methods

  • David Lee

    Research Associate III

    Seattle Genetics, Inc.

    A Multipronged Approach to Develop an In-House Chemically-Defined Media System for a CHO Fed-Batch Process

  • Naveenganesh Muralidharan

    Senior Engineer, Tech Transfer, Manufacturing Science and Technology

    Patheon, part of Thermo Fisher Scientific

    Small-Scale Model Development That Mimics the Manufacturing Scale CO2 Profile

  • Christopher W. Kemp, PhD

    President

    Kempbio, Inc.

    Comparing Insect Culture and Mammalian Expression Systems

  • Mark F. Witcher, PhD

    Semi-Retired Engineer/Executive

    Successful Product Development – Yield, Purity, and Comparability: How Many Products Fail Phase III Clinicals
    Because They Are Not Comparable to the Product Designed and Tested Earlier?

  • Clare M. Allocca

    Senior Advisor for Standardization, Standards Coordination Office

    National Institute of Standards & Technology

    Assuring Fitness-for-Purpose in Biobanking: Standards Development in ISO/TC276 Biotechnology

  • Daniel Eshete, MD, PhD

    Senior Scientist

    Pall Biotech

    Virus Filtration in Continuous Bioprocessing: Considerations for Filter Design Space and Validation

  • Rosemary J. Versteegen, PhD

    Chief Executive Officer

    International Serum Industry Association

    Where in the World Did Your FBS Come From? Geographic Testing for Serum Origin

  • Marcin Łoś, PhD, DSc

    Chief Executive Officer

    Phage Consultants

    Phage Contamination in a Fermentation Facility: What Can be Done, Except for Burning it Down, to Stop the Phage?

  • Nikki Nogal, PhD

    Senior Consultant Biologics Product Development

    Latham BioPharm Group

    Modulation of Cell Culture Productivity and Product Quality Through Optimization of Production Media

  • Antonio J. Scatena

    Sr. Sales Representative

    Gateway Analytical LLC

    Source Determination Testing of Foreign and Unknown Particulate Matter in Pharmaceutical Products

  • Fang Tian, PhD

    Lead Scientist, Cell Biology Group Leader

    American Type Culture Collection (ATCC)

    A Comprehensive View of Cell Authentication and Characterization

  • Sherri Dolan

    Global Technology Consultant - Virus Clearance

    Sartorius Stedim Biotech

    Virus Risk Mitigation in Cell Culture Media Using Virus Retentive Membranes

  • Kelvin G.M. Brockbank, PhD

    CEO

    Tissue Testing Technologies LLC

    Trehalose as an Alternative to DMSO for Cryopreservation of Cells

  • Steve Broach

    Sales and Business Development - Biobanking

    LiCONiC Instruments

    Current Trends in Storage and Usage of Biological Samples: Supporting the Biologicals Revolution in Life Science

  • Frank Romanski, PhD

    Global Technical Marketing Manager

    BASF Corporation

    Determination and Quantification of Hydrophobic Impurities Shown to Cause Variable Cell Culture Performance in Poloxamer 188 Using RP-HPLC

  • Donald L. Jarvis, PhD

    President

    GlycoBac LLC

    The Wild-Type Ancestor of Sf-Rhabdovirus Can Infect Monkey Cells

  • Thomas Matthews, PhD

    Scientist II

    Biogen

    Enabling Rapid Raw Material Identification and Release by Raman Spectroscopy and X-Ray Fluorescence

  • Eric Gershenow

    Senior Scientist, Scientific Laboratory Services Continuous BioProcessing

    Pall Biotech

    Process Design and Scaling of Multi-Column Chromatography for Capture of Monoclonal Antibodies

  • Tod Canty

    President

    JM Canty, Inc.

    Using Dynamic Imaging for Foam Control Level Particle Count and Cell Counting

  • Michael Butler, PhD

    Chief Scientific Officer

    National Institute for Bioprocessing Research & Training (NIBRT)

    Bioprocess Strategies to Control Product Glycosylation in Mammalian Cell Culture

  • Daisie Ogawa

    Engineer II, Bioprocess Engineering

    Boehringer Ingelheim Corporation

    Highly Intensified Perfusion Cell Culture: Making More Therapeutic Protein, Faster, in a Smaller Manufacturing Footprint Than Traditional Fed-Batch Processes

  • Reed Shabman, PhD

    Lead Scientist - Virology

    American Type Culture Collection (ATCC)

    An Overview of ATCC Custom Solutions: Capabilities and Highlights

  • Mark F. Witcher, PhD

    Semi-Retired Engineer/Executive

    Using Lifecycle Development Tools Including Risk Analysis for Building Better Infrastructure Systems (e.g., Controlling Raw Materials) or, Getting to Six-Sigma Performance

  • Salim P. Charaniya, PhD

    Principal Engineer/Senior Manager, Global Manufacturing Sciences and Technology

    Genentech, a Member of the Roche Group

    Towards Eliminating the Impact of Raw Material Variability in Biologics Manufacturing: A Case Study with Poloxamer 188

  • Balasubramanian Ramanathan, PhD

    Senior Scientist

    Janssen Research & Development, LLC

    Impact of Elemental Impurities on Complex Chemically Defined Media

  • Laura Viggiano Salta

    Manager of Analytical Sciences/Quality Control

    Oncorus

    Optimization of Neutralizing Antibody Conditions for Adventitious Virus Testing of micro-RNA Attenuated Oncolytic Herpes Simplex Virus

  • Priyanka Gupta

    Global Process Modeling Manager

    Sartorius Stedim Biotech

    Evaluation of New and Current Process Intensification Scenarios For Predicting the Most Cost-Effective Processes

  • Kristi Daris

    Scientist

    Amgen Inc.

    Limitations of Subcloning as a Tool to Characterize Homogeneity of a Cell Population

  • Danming Tang, PhD

    Technical Development Scientist, Cell Culture Department

    Genentech, a Member of the Roche Group

    Two Cytoplasmic Ubiquitin E3 Ligases and an ER Protease Mediate ER-Associated Degradation of Unfolded Antibody Heavy Chains

  • Sherman Ku, PhD

    Scientist

    Just Biotherapeutics, Inc.

    Development of a Targeted Integration System for Therapeutic Protein Expression

  • Christian Müller, PhD

    Principal Scientist and Team Lead

    AGC Biologics

    Accelerated Timelines to IND and from Process Characterization to PPQ Through Implementation of Various HT-Technologies

  • Cory J. Card

    Principal Scientist

    GE Healthcare

    Impact of Impurities in Industrial Cell Culture: Understanding and Managing Variation

  • Indrajit Giri

    Director, QC Raw Materials and Contract Testing

    Immunomedics, Inc.

    Raw Material Control Strategy in a Cell Culture-Based Biologics Manufacturing Process

  • Michael C. Borys, PhD

    Director, Upstream Processing, Biologics Process Development

    Bristol-Myers Squibb Company

    Next Generation Manufacturing: Adopting a Hybrid Model for Continuous Processing

  • Nahid Turan, PhD

    Chief Laboratory Officer

    Coriell Institute for Medical Research

    Biobanking Samples and the Need to Raise the Standard: Are Your Samples Fit for Purpose?

  • Alissa M. Resch, PhD

    Chief Scientific Officer; Principal Investigator, NHGRI Sample Repository for Human Genetic Research

    Coriell Institute for Medical Research

    Assessing Genomic Stability and Quality in Cell Lines

  • Afshin Sohrabi, PhD

    Principal Scientist, Head of Near Real-Time Testing Lab

    MilliporeSigma BioReliance® Services

    Faster Test, Faster Results: Degenerate PCR Panel Assay for Biosafety Testing

  • Gitanjali Talreja

    Associate Scientist II

    Biogen

    Refractive Index Technology to Model Raw Material Dissolution Consistency for Media Hydration Operations

  • Eric A. Rudolph

    Vice President & Business Manager, Single Use Solutions

    ABEC, Inc.

    Flexible Bioprocess Design for Maximizing Upstream Throughput

  • Jim Vaught, PhD

    Editor-in-Chief

    Biopreservation and Biobanking

    The Importance of Biobanking for Precision Medicine and Public Health

  • Jean Qiu, PhD

    Chief Technology Officer, Founder

    Nexcelom Bioscience LLC

    Cell Count, Viability, and Cell Health Characterization Using Image Cytometry

  • Maura Kibbey, PhD

    Director, Science & Standards, Global Biologics

    US Pharmacopeial Convention (USP)

    USP Standards to Support Qualification of Raw Materials and Cell Substrates for Biomanufacturing

  • Ioana Erlandsson

    Functional Design Manager, Customized Bioprocess Solutions

    GE Healthcare Bio-Sciences AB

    Deploying Automated Buffer Production for cGMP Use

  • Jonathan J. Cacciatore, PhD

    Associate Principal Scientists

    Merck & Co., Inc.

    Raw Material Investigations for Managing Variability in Charge Variant Profiles of a Monoclonal Antibody