Cambridge Healthtech Institute’s 2nd Annual
Single-Use Technologies and Continuous Processing
A New Manufacturing Paradigm with Increased Flexibility and Productivity While Reducing Cost
January 19-20, 2015
Single-use technologies and continuous processing are the two key drivers in the bioprocessing industry today. Although each can be implemented on its own, the combination of single-use with continuous processing promises to bring even greater flexibility and productivity gains. CHI’s Second Annual Single-Use Technologies and Continuous Processing conference highlights the risks, challenges, opportunities and strategies for implementing these two separate yet complementary technologies, and showcases how companies can drive value and increase productivity through these innovations.
KEYNOTE PRESENTATIONS: A NEW BIOMANUFACTURING PARADIGM
Driving Value through Innovation in Biologics Manufacturing
Jorg Thommes, Ph.D., Vice President, Operations, Technology & Innovation, Biogen Idec
Towards Biomanufacturing on Demand
Christopher Love, Ph.D., Professor, Chemical Engineering, MIT
A Lifecycle Approach to Management of Leachables & Extractables Related Risk in Processes with Significant Investment in Single Use Components
Naveen Pathak, MS, Director, MS&T, Process Development & Manufacturing Science, Shire
Extractables and Leachables from Single-Use Components - Can They be Cleared through Ultrafiltration/Diafiltration (UF/DF) Process?
Kate Lee, Ph.D., Process Development Engineer, Genentech, Inc.
Developing a Risk Mitigation Strategy for the Implementation of Single-Use Systems
Xavier Derouck, Senior Sourcing Group Manager, Bioprocess Single-Use Technology, Global Production Procurement, GSK Biologics
Implementation Strategies and Challenges for Single-Use at Clinical to Commercial Scale: Leaks, Integrity Testing, Material Qualification, Bioburden, Handling Risk, etc.
Adam Goldstein, MS, Senior Manager, Technical Operations, Genentech, Inc.
Mitigating Scale-Up and Process Challenges for Microbial Fermentation in Single-Use Production Vessels
Rajesh Krishnan, Ph.D., Director, BioProcess Development, Gilead Sciences
Speed to Clinic Biosimilar Platform
Eszter Birch-Wilson, Ph.D., CTO, STC Biologics, Inc.
Single-Use Bag Extractable Case Study: Lessons Learned
Mike Johnson, Global Bioprocess Applications Manager, Entegris, Inc.
BPSA Update: Standards and Recommendations for Extractables and Particulates Control
Jerold M. Martin, MSc, Chairman, BPSA BoD and Technology (E&L) Committee Co., Inc.; Member, BioPhorum Operations Group (BPoG)
James Dean Vogel, PE, Founder and Director, The Bioprocess Institute and Chair, BPSA Particulates Workgroup
BPOG Update: Driving Adoption of Single-Use into cGMP: Reflections of the BPOG End Users Disposable Working Group
David Pollard, Ph.D., Executive Director, Bioprocess Development, Merck Research Laboratories, Merck &Co.
mAbs for the Masses: Towards Automated Continuous Processing Enabled by Single-Use
David Pollard, Ph.D., Executive Director, Bioprocess Development, Merck Research Laboratories, Merck & Co., Inc.
Continuous Upstream Processing – Single-Use versus Standard Technologies
Berthold Boedeker, Ph.D., Chief Scientist, GDD-Global Biologics-Biotech Development, Bayer Pharma AG
Novel Concepts for Protein Production – Status and Path Forward
Thomas Daszkowski, Ph.D., Vice President, Process Design & Optimization, Bayer Technology Services
Continuous High-Throughput Downstream Processing for Biologics
Thomas Mueller-Spaeth, Senior Scientist, Institute for Chemical and Bioengineering, ETH Zurich
Can Continuous Processing and Single-Use Benefit Vaccine Manufacturing?
Ronald Neeleman, Ph.D., Senior Director, Vaccine Innovation and Virology Expert, Global Technology Innovation, Sanofi Pasteur