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Cambridge Healthtech Institute’s 2nd Annual
Single-Use Technologies and Continuous Processing
Driving Value Through Process Innovations
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.

Preliminary Agenda 


KEYNOTE PRESENTATIONS: A NEW BIOMANUFACTURING PARADIGM

Driving Value through Innovation in Biologics Manufacturing

Thommes_JorgJorg Thommes, Ph.D., Vice President, Operations, Technology & Innovation, Biogen Idec


Towards Biomanufacturing on Demand

Christopher LoveChristopher Love, Ph.D., Professor, Chemical Engineering, MIT


 

SINGLE-USE TECHNOLOGIES: RISKS, CHALLENGES AND IMPLEMENTATION STRATEGIES 


A Lifecycle Approach to Management of Leachables & Extractables Related Risk in Processes with Significant Investment in Single Use Components

Naveen PathakNaveen 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 LeeKate Lee, Ph.D., Process Development Engineer, Genentech, Inc.


Developing a Risk Mitigation Strategy for the Implementation of Single-Use Systems

Xavier DerouckXavier 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


Single-Use Bag Extractable Case Study: Lessons Learned

Mike Johnson, Global Bioprocess Applications Manager, Entegris, Inc.




STANDARDS AND RECOMMENDATIONS FOR SINGLE-USE TECHNOLOGIES AND PROCESSES 

BPSA Update: Standards and Recommendations for Extractables and Particulates Control

Jerold M. MartinJerold 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 PollardDavid Pollard, Ph.D., Executive Director, Bioprocess Development, Merck Research Laboratories, Merck &Co.


 

CONTINUOUS PROCESSING: TRENDS, OPPORTUNITIES AND CHALLENGES 

KEYNOTE PRESENTATION

mAbs for the Masses: Towards Automated Continuous Processing Enabled by Single-Use

David Pollard

David Pollard, Ph.D., Executive Director, Bioprocess Development, Merck Research Laboratories, Merck & Co., Inc.


 

Continuous Upstream Processing – Single-Use versus Standard Technologies

Berthold BoedekerBerthold Boedeker, Ph.D., Chief Scientist, GDD-Global Biologics-Biotech Development, Bayer Pharma AG



Novel Concepts for Protein Production – Status and Path Forward

Thomas DaszkowskiThomas Daszkowski, Ph.D., Vice President, Process Design & Optimization, Bayer Technology Services


Continuous High-Throughput Downstream Processing for Biologics

Thomas Mueller-SpaethThomas Mueller-Spaeth, Senior Scientist, Institute for Chemical and Bioengineering, ETH Zurich


Can Continuous Processing and Single-Use Benefit Vaccine Manufacturing?

Ronald NeelemanRonald Neeleman, Ph.D., Senior Director, Vaccine Innovation and Virology Expert, Global Technology Innovation, Sanofi Pasteur