Poster Presentations September 2013

Cell Culture and Upstream Processing

Gary Boch (Cevec Pharmaceuticals)

Custom Chemically Defined Media for CAP-T Cells

Maurizio Cattaneo (BioVolutions)

DoE for Continuous BioProcessing of Therapeutic Monoclonal Antibodies

Stephanie Dubois (ATMI LifeSciences)

Linear Scalability of Virus Production in Integrity^®iCELLis^®Single-Use, Fixed-Bed Bioreactors from Bench Scale to Industrial Scale

Thomas Falkman (GE Healthcare)

Assessment of Process Performance and Product Quality in High-Performing Fed-Batch Cultures

Kathleen Harrison (Frieslandcampina Domo)

Influence of Soy Protein Hydrolysates on Robustness of Cell Culture Experiments

Clint Pepper (Bend Research)

Leveraging the Modular, Automated Sampling Technology (MAST) Platform for Merging In-Line and At-Line Analytical Technologies to Gain Optimized Cell-Level “Observability” and Data-Driven Process “Guidance”

Wilson Lee (Charter Medical)

Microbial Cultivation in Different Scales in the CELL-tainer^® Wave-Mixed Single-Use Bioreactor

Matthew Kremer (ATMI LifeSciences)

Viral Vector Production in the Integrity^®iCELLis^®Single-Use Fixed-Bed Bioreactor: From Bench Scale to Industrial Scale

Akinori Hishiya (Boston Strategics)

TAPBOOST Technology: Novel Technology to Enhance the Production of Therapeutic Recombinant Proteins Through Protein Folding System

Ying Huang (National Institutes of Health)

An Integrated Approach Toward Developing a Robust CHO Cell Line Development Platform

Ting-Kuo Huang (Genentech)

Evaluation of Adventitious Agent Barriers toLeptospiraspecies: A Novel Bacterial Contamination in Cell Culture Manufacturing

Ying Huang (Vaccine Production Program Laboratory)

An Integrated Approach Toward Developing a Robust VPPL Cell Line Development Platform

Xiaoxia Jin (Genzyme, a Sanofi Company)

Development of a Perfusion-Based Non-Centrifugal High-Density Cell Banking Platform

Kalle Johnson (Thermo Fisher Scientific)

Achieving High Titers Using CHO Cells to Express Proteins in a Single Medium for Growth and Transient Transfection in Batch Culture

Ben Madsen (Thermo Fisher Scientific)

Scale-Up Studies in Single-Use Environment to Achieve High Cell Density Cultures

Jinghui Qian (Repligen)

LONG^®R3 IGF-1 Supplementation Results in Improved CHO Productivity Versus Insulin in Modern CHO Fed-Batch Media

Ariane Marolewski (Repligen)

Development and Characterization of a LONG®R3 IGF-1 ELISA Kit

Gerald McEwen (Thermo Fisher Scientific)

Optimizing a Single Serum-Free Medium for High-Density Growth and High-Efficiency Transient Transfection of Multiple HEK293 Cell Lines Using Conventional Reagents and Methods

Fabien Moncaubeig (ATMI LifeSciences)

Scale-Up of Hepatic Progenitor Cells from Multiple Tray Stack to 2-D Bioreactors

Tal Murthy (PerkinElmer)

Building Efficient Protein Biologics Workflows Using Microchip Analysis Platforms

Douglas Osborne (Biogen Idec)

Optimization of Cell Banking Parameters for a Temperature-Sensitive Cell Line

Sonal Patel (EMD Millipore)

Accelerating Time to Market for Proprietary Cell Culture Products by Leveraging Statistical Design of Experiments and High-Throughput Liquid Handlers

Katherine Strathearn (Corning Life Sciences)

Method for Scaling Up and Producing Adenoviral and Lentiviral Particles in the Corning^®HYPERStack^®Cell Culture Vessel

Katherine Strathearn (Corning Life Sciences)

Corning^®Enhanced Attachment Microcarrier Beads Offer an Alternative to Existing Vessel Technologies for the Culture and Expansion of Cell Lines Used in Vaccine Production

Nicholas Sullivan (Gallus BioPharmaceuticals)

Effects of Lowering Culture Temperature in a Continuous Perfusion Platform for Optimization of Upstream Bioprocessing

Yogesh Waghmare (Genzyme, a Sanofi Company)

Bioreactor Mass Transfer Simulator: Predictive Tool for Understanding, Design and Optimization

Jennifer Weber (Corning)

Evaluation of Microcarrier-Based Suspension Cultures for Human Mesenchymal Stem Cells

Bo Yu (Larix Bioscience)

Antibody Membrane Switch (AMS) Technology for Facile Cell Line Development

Recovery and Purification

Andrew Barry (PerkinElmer)

Small-Scale Protein Purification for Rapid Optimization of Biotherapeutic Protein Production

Greg Warner (PerkinElmer)

Development of AlphaLISA Assays for Quantification and Characterization of Biotherapeutic Proteins and Process Contaminants

Bharat Buht (Bristol-Myers Squibb)

Protein High-Concentration (>170 g/L) Formulations: Development of an Optimized and Scalable Ultrafiltration Process to Minimize Protein Aggregation

Paul Byrne (Covance)

Residual DNA Testing: Design, Validation, Optimization, and Overcoming Sample Matrix Interference

Yamuna Dasarathy (Pall LIfe Sciences)

Efficient Separation of Antibody Light Chains from Bispecific Antibody Monomer Using Mixed-Mode Sorbents

Bruce Dawson (Life Technologies)

CaptureSelect^®Affinity Chromatography Ligands and Resins for Laboratory and Process-Scale Applications

Chase Duclos-Orsello (EMD Millipore)

Accelerating MAb Downstream Process Development Using a Pre-Selected PD Kit

Melissa Holstein (EMD Millipore)

A Case Study: Three-Step Process for Efficient Mab Purification Using Different Commercially Available Chromatography Resins

Charlie Huang (Anteo Diagnostics)

Versatile Protein Coating on Magnetic Particles for Bioseparation

James Stout (Natrix Separations)

Progress on a Fully Disposable Downstream Platform: A Simple, Plug-In Solution to the Downstream Bottleneck for Flexible Facilities and Traditional Manufacturing of MAbs

Fabien Rousset (Novasep)

Disruptive Technologies for High-Performance Downstream Processing

Chinlun Huang (Tosoh Bioscience)

Characterization of an Experimental High-Capacity and Alkaline-Stable Recombinant Protein A Resin

Ganesh Iyer (EMD Millipore)

A Scalable Method for Packing Chromatography Columns

Takuo Kawase (Chugai-pharmaceutical)

What is the Most Productive Protein A Media for Therapeutic Antibody Manufacturing?

Ting Yang (Shire)

Application of Quality By Design Principles to the Development of a Design Space for a Cation-Exchange Chromatography Purification Step

Mikhail Kozlov (EMD Millipore)

Next-Generation Polishing Technologies for Robust Host Cell Protein and MAb Aggregate Removal

Yixin Lin (Pall ForteBio)

New Strategies for High-Throughput Label-Free Characterization of Biotherapeutics

Fletcher Malcom (Repligen)

Implementing Disposable Chromatography: Technology Fit in Downstream Purification

Masayoshi Nagaya (JSR Life Sciences)

Introduction and Evaluation of a Novel Alkali Stable Protein A Resin: Amsphere Protein A JWT203

Arleene Velayo (Gilead Sciences)

Overcoming
Artifacts During Virus Filter Validation: A Case Study

Manufacturing Strategy

Daniel Carraher (Genzyme)

Development and Implementation of a Process Control Strategy for a Legacy Biologics Product

Anna Heijbel (GE Healthcare)

Platform Purification of a Domain Antibody

Mike Johnson (Entegris)

Risk Mitigation Through Component Material Selection Including Extractable Data from Materials of Construction

Wendy Sunderland (Lyophilization Technology)

Evaluating the Impact of Controlled Nucleation on Lyophilized Product Attributes and Processing Characteristics in an Aseptic Environment

Lakshmi (Prasad) Pathange (Bayer HealthCare)

Use of a Simple Visual Tool to Monitor Commercial-Scale Purification Process Performance on the Manufacturing Floor

Chad Atwell (Genzyme)

Defining the Boundary Between Process Development and GMP Manufacturing: Starting Up a Manufacturing Science Laboratory

Dogan Omek (Lonza Biologics)

Characterization ofk_LaUsing Definitive Screening Designs for Fermentation Scale-Up

Analytical and Quality

Bruce Andrien (Alexion Pharmaceuticals)

A Platform Methodology for Maximizing N-Terminal Sequence Coverage in Therapeutic Proteins By Improving MALDI Top-Down Sequencing

Sricharan Bandhakavi (Bio-Rad Laboratories)

Enhanced 2D Electrophoresis and Western Blotting Workflow for Reliable Evaluations of Anti-HCP Antibodies

Lew Brown (Fluid Imaging Technologies)

The Importance of Thresholding in Imaging Analysis of Protein Aggregates

Carla Conant (ATMI LifeSciences)

Using Helium Integrity Tester to Increase Assurance of Sterility of Single-Use Assemblies

Caroline DiCesare (Genzyme, a Sanofi Company)

Evaluation of the Cedex Bio and HT Metabolite Analyzers for Cell Culture Process Monitoring

Guillermina Forno (Zelltek)

Optimization of O-glycans Stuctural Analysis By Nonreductive Alkaline Beta-Elimination

Andrea Hawe (Coriolis Pharma Research

Differentiation of Protein Particles and Silicone Oil Droplets by Flow-imaging Microscopy (MFI and FlowCAM) and Resonant Mass Measurement (Archimedes)

David Lansky (Precision Bioassay)

Near-Universal Similarity Bounds for Bioassays

Kristin Scharf (New England Controls)

Improve Manufacturing Reliability by Implementing Predictive Maintenance

David Yamane (Freeslate)

High-Throughput Viscosity Measurement for Assessing Biologics Formulations

Formulation and Delivery

Walter Ausserer (Pall Life Sciences)

The Use of Temperature-Dependent Intrinsic Fluorescence for the Analysis of In-Process Stability of a Protein

This is just a sampling of the posters that will be on display in the exhibit hall at the BioProcess International Conference and Exhibition. These early arrivals will be joined by more in their categories, as well as others in Vaccine Development and Production.