- ● 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
Agenda-at-a-Glance
- • 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.
- • Capacity, Technology and Innovation Trends in a High Variety Product Portfolio World
- >Simon Chalk, Director, BioPhorum Operations Group (BPOG), United Kingdom
- • 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
- • 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
- • 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
- • 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
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
- • 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
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