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BioProcess International

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Biopharmaceutical Development & Production Week

CSS

Innovation and Adoption of New Methods and Technologies for Emerging Biologics and Facilities of the Future

850+ Attendees · 175 Speakers · 60+ Exhibitors · 80+ Posters

March 30 - April 02, 2015 · Hyatt Regency Huntington Beach Resort & Spa · Huntington Beach, CA

Preliminary Agenda

Preliminary Agenda

Preliminary Agenda & Early Confirmed Speakers

Get out of the office and join a new how-to environment that lets you concentrate on development and production challenges in the most effective and efficient ways possible. No matter where you work in the development and production path, everyone in your organization can benefit by attending BDP Week 2015.

Process DevelopmentAnalyticalManufacturingQuality & RegulatoryEngineering

Early Confirmed Keynotes

Tae Han Kim, Ph.D., President Chief Executive Officer, Samsung BioLogics

James Swartz, James H. Clark Professor in the School of Engineering and Professor of Chemical Engineering and of Bioengineering, Stanford School of Medicine

9 Focused Tracks to Help Your Improve Speed, Quality, Efficiency and Compliance

Manufacturing Efficiencies: Strategy and Technology

  • Scale Up, Scale Down and Technology Transfers
  • Fully-Continuous Manufacturing
  • Portfolio Planning and Lifecycle Management
  • Strategies for Manufacturing Novel Modalities
  • Technologies to Increase Efficiency and Optimize Production
  • Achieving Operational Excellence
  • Relaxing Environmental Controls

Upstream Processing

  • Novel Approaches in Cell Line Engineering
  • Bid Data and Genomic Tool Implementation
  • Synthetic Biology Applications in Cell Culture
  • Overcoming Development Challenges for Difficult Proteins
  • Developments in Late Stage Cell Culture - Models, Scale Up and Tech Transfers
  • New Paradigms in Media Development and Optimization
  • Streamlining Process Development Timelines
  • Efficient Implementation of Continuous Upstream Processes

Downstream Processing

  • Disruptive Harvest Step Technologies
  • Challenges in Scale Up/Scale Down
  • Implementation of Novel Methodologies and Technologies
  • Next Generation Downstream Processing - Column-Free Processes
  • Developing Processes for New Modalities
  • Innovation in Materials Science for Next Generation Purification
  • Characterization and Control of Variants and Impurities
  • Improving Flexibility through Process Design and Facility Fit
  • Advances in High-Throughput Methods
  • Enabling Continuous Processing with Integrated Single-Use Technologies

Single-Use New This Year

  • Integrity Testing of Single-Use Assemblies
  • Single-Use vs. Tradition Reusable Probes
  • Batch versus Perfusion Mode
  • Extractables and Leachables and Particulate Control
  • Cell Culture Application Considerations
  • Continuous Processing and Closed Systems

Flexible Facilities New This Year

  • Strategies for Single-Use Implementation
  • Process Development and Manufacturing Strategies
  • Flexible/Multiuse Facility Design Considerations
  • Cleaning and Monitoring Strategies for Efficient Changeovers
  • Regulatory Considerations for Flexible/Multiuse, and Facilities of the Future

Analytical

  • Comparability Strategies for Biosimilars and Other Biotechnology Products
  • Characterization and Control Host Cell Protein, Variants and Impurities
  • High-Throughput Analysis and Methods
  • Glycan Analysis Considerations
  • Aggregation and Subvisible Particle Characterization

Process Validation

  • Continuous Manufacturing Best Practices
  • Regulatory Considerations For New Manufacturing Efforts
  • QBD Concepts in the Commercial Phase
  • Tools to Establishing Reliable Data
  • Biosimilars Development and Production
  • FDA Breakthrough Therapy Designation

Viral Safety

  • Next Generation Sequencing to Detect Novel Viruses
  • Regulatory Guidance for Adventitious Agents
  • Prioritizing Threats Through Risk Assessments
  • High-Temperature Short-Time (HTST) Processing
  • Ultraviolet Light in C Spectrum (UVC) Treatment
  • Nanofiltration Approaches and Concerns

Raw Materials and Supply Chain

  • Improved Raw Materials Characterization
  • Tracing Raw Materials from Origin
  • Monitoring Raw Materials in Real Time
  • Mitigating New Scenarios for Supply Chain Disruptions
  • Control Strategies for Aging Cell Banks
  • Animal-Sourced Supplies as Raw Materials

Confirmed Speakers

  • Featured Speaker: Tina S. Morris, Ph.D., Vice President, Biologics & Biotechnology, U.S. Pharmacopeial Convention
  • Monica Lent, Head of Process Validation and Knowledge
  • Kim Wong, Ph.D., Director, Facilities & cGMP Support, Bioprocess R&D, Sanofi Pasteur
  • Thomas Kreil, Ph.D., Senior Director, Global Pathogen Safety, Baxter BioSciences
  • Nathan Roth, Ph.D., Director, Pathogen Safety, Global R&D, CSL Behring
  • Emiliano Toso, Ph.D., Molecular Biology Group Head, Merck Serono
  • Paul Duncan, Ph.D., Senior Principal Scientist, Vaccine Analytical Development, Merck & Company, Inc.
  • Dayue Chen, Ph.D., Senior Research Advisor, Process Development, Eli Lilly and Company
  • Lada Laenen, Ph.D., Senior Director; Head of Manufacturing Science and Technologies, Genzyme Corporation
  • Camellia Zamiri, Ph.D., Scientist, Genentech
  • Parastoo Azadi, Ph.D., Technical Director, Complex Carbohydrate Research Center, University of Georgia
  • Xiaoyu Chen, Section Leader, Late Stage Analytics, Merck
  • Galahad Deperalta, Ph.D., Scientist, Genentech
  • John P. Marino, Ph.D., Leader, Biomolecular Structure & Function Group, NIST
  • Johnson Vargehese, Ph.D., Senior Director, Shire
  • Vladamir Razinkov, Principle Scientist, Process & Product Development, Amgen, Inc.
  • Nadine M. Ritter, Ph.D., Senior CMC Consultant, Biologics Consulting Group, Inc.
  • Denise Krawitz, Ph.D., Senior Manager, Analytical Operations, Genentech, Inc.
  • Dr. Jeffrey W. Hudgens, Research Chemist, Institute for Bioscience and Biotechnology Research (CARB II/2204B), BioProcess Measurements Group (Div. 645.07), Biomolecular Measurement Division, National Institute of Standards and Technology
  • Padmadhar Madupu, MS, Manager Process Engineering/ Development, Genzyme
  • Adam Goldstein, Principal Scientist, Global Manufacturing Sciences, Genentech, Inc.
  • Paul Ko, Ph.D., Senior Scientist, Janssen
Environmental Monitoring & Contamination Control