Friday, July 4, 2014

BioProcess International Spotlight: Manufacturing Strategy

Learn how to maximize your efficiencies and cost savings across your manufacturing network through the implementation of disruptive technologies, operational excellence and new facility concepts, while remaining flexible to the production needs of a diverse pipeline of novel molecules in a multiproduct environment.
  • ● New Concepts in Biomanufacturing
  • ● BPOG Strategic Workstreams
  • ● Tech Transfer & Scale-up/Scale-down
  • ● Continuous Manufacturing
  • ● Single-use Applications & Town Hall Forum
  • ● Relaxing Environmental Controls in Facilities

The Evolving Landscape of Biomanufacturing
  • • Transforming Biopharmaceutical Manufacturing
    • >Randy J. Maddux, Vice President and Site Director, GlaxoSmithKline
  • • Biomanufacturing Strategies to Prepare for the Pipeline of the Future
    • >Philippe-Alexandre Gilbert, Ph.D., Head of Upstream Development, Novartis Vaccines & Diagnostics, Inc.
  • • Operational Excellence & Six Sigma Efficiency in Biomanufacturing
    • >Jonathan Blackie, Senior Director of Business Process Integration, BioMarin Pharmaceutical, Inc.
BPOG Strategic Workstreams: Progress and Industry Updates
  • • Capacity, Technology and Innovation Trends in a High Variety Product Portfolio World
    • >Simon Chalk, Director, BioPhorum Operations Group (BPOG), United Kingdom
BPOG Strategic Workstream Updates
  • • Reflecting cGMP Requirements down the SUS Supply Chain
    • >Tony White, Director, BioPhorum Operations Group (BPOG), United Kingdom
  • • Continued Process Verification: A Model Plan Based on Cross-Industry Knowledge
    • >Brett Frohlich, Ph.D., Director of Bioengineering, Shire
BPOG Strategic Workstreams: Progress and Industry Updates (continued)
  • • Microbiological Monitoring for Biological Drug Substance Manufacturing - An Industry Perspective
    • >David Bain, Ph.D., Facilitator, BioPhorum Operations Group (BPOG), United Kingdom
  • • Raw Materials Variability: The Need for Supply Chain Collaboration, Transparency and Mutually Beneficial Relationships
    • >Matthew Muldoon, Sourcing Manager, Strategic Sourcing Raw Materials & Medical Devices, Bayer HealthCare LLC
Case Studies of Technology Transfer and Scale-up/Scale-down
  • • New Data: Revamping a Technology Transfer Process to Maximize the Efficiency of a Multi-product
  • Facility: Accommodating Transfer of Phase 1 Clinical to Commercial Process
    • >Jim McColgan, Director, Site Technical Services, Pfizer Global Supply
  • • Case Study * New Data: Overcoming Technical Challenges while Transferring a Bacterial Production Process into Manufacturing
    • >Rick St. John, Ph.D., Senior Group Leader, Purification Development, Genentech, Inc.
  • • New Data: Challenges during Scale Down and Up of E.coli Processes
    • >Britta Krampe, Ph.D., Process Engineering Manager, Roche, Germany
Continuous Processing for Manufacturing Sponsored By: Novasep
  • • Case Study * New Data: Progress towards Efficient Implementation of Continuous Upstream Processes in Early Development
    • >Daryl Powers, Ph.D., Senior Scientist, Early Cell Culture Development, Sanofi Global Biotherapeutics
  • • Case Study * New Data: mAbs for the Multitude by Automated Continuous Processing Enabled by Single Use
    • >David Pollard, Ph.D., Executive Director, BioProcess Development, Merck & Co Inc.
  • • New Data: Design and Optimization of Countercurrent Tangential Chromatography for Monoclonal Antibody Purification
    • >Andrew Zydney, Professor and Department Head, Chemical Engineering, The Pennsylvania State University
  • • Case Study * New Data: Using Continuous Precipitation for the Purification of High Titer
  • Monoclonal Antibodies
    • >Robert S. Gronke, Ph.D., Senior Principal Scientist, Biogen Idec
  • • Continuous Chromatography, A Multi-Angle Solution to Drive mAb Capture Step Costs Down
    • >Fabien Rousset, Ph.D., Deputy Director, Head of Biopharma Technologies, R&D, Novasep, France
  • • Case Study * New Data: ASAP: Toward a Fully Disposable Continuous Process
    • >Benoit Mothes, Pharm.D., Senior Scientist, DSP Process Development, BioProcess Science and Technologies, Sanofi
The Next Wave of Single Use Manufacturing: Closed Systems, New Technology and Cost Comparisons
Sponsored by: Life Technologies & Thermo Scientific
  • • Case Study * New Data: Biomanufacturing Using Solely SU Technologies - Case Study and Cost Comparisons with a SS Facility
    • >Venkatesh Natarajan, Ph.D., Senior Process Engineer III, Global Engineering Sciences, Biogen Idec
  • • UNICAN: Dual Capability in Single Use Bioreactor
    • >Edward Chan, Technical Specialist, Cell Culture Pilot Plant, Genentech
  • • Case Study: Disposables and Closed Systems Operation as Tools to Support the "Facility of the Future" Concept
    • >Berthold Boedeker, Chief Scientist, Bayer Healthcare AG, Germany
  • • Single-Use Systems - Expanding Platforms
    • >Daniel Nelson, Integrated Solutions Product Manager, Thermo Fisher Scientific
An Interactive Town Hall Forum on Standardization of Single-Use Systems: What is the Next Step for the Industry?
  • • Featuring updates from ASME BPE, ASTM, BPOG, BPSA, PDA, USP and ELSIE
  • Speakers and Panelists:
    • >Jay Ankers, Director of Technology, M+W Group
    • >Robert Steininger, Senior Vice President, Manufacturing, Acceleron Pharmaceuticals, Inc.
    • >Tony White, Director, BioPhorum Operations Group (BPOG), United Kingdom
    • >Jerold Martin, Senior Vice President, Global Scientific Affairs, Pall Life Sciences
    • >Bob Repetto, Senior Director, External Affairs, Pfizer
    • >Dennis Jenke, Ph.D., Baxter Distinguished Scientist, Technology Resources, Baxter Healthcare Corporation
    • >Douglas J. Ball, Research Fellow, Pfizer
  • Point-Counterpoint Session
  • • Challenges and Considerations around Relaxing Environmental Controls in Biopharmaceutical Facilities
    • >Kristin Murray, Director, GCMC Regulatory Affairs, Pfizer
    • >Stephen Reich, Director, Quality Systems & Compliance, Pfizer
  • • Point-Counterpoint Session: Challenges and Considerations around Relaxing Environmental Controls in Biopharmaceutical Facilities
  • Speakers and Panelists:
    • >Jeffrey Skene, Acting Chief, Monoclonal Antibodies Division, Health Canada
    • >Marc Pelletier, Ph.D., Director of Biotechnology, CRB Consulting Engineers
    • >Joel Gates, Director of Quality Assurance, Shire
    • >Alex Tschumakow, Director, Manufacturing, Shire
    • >Anastasia Lolas, Owner & President, Visionary Pharma Consulting LLC
    • >Smock, Biotechnology Quality and Technical Consultant
Find out more the sessions in this year's Manufacturing track along with the rest of the agenda by downloading the brochure. BioProcess International will take place October 20-23, 2014 in Boston, MA. As a reader of this blog, you are eligable to save 20% off the standard rate when you register to join us and mention code BPI14BLOG.

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