January 18-22, 2016 | Town and Country Resort Hotel | SAN DIEGO, CA 
January 18-22, 2016 | Town and Country Resort Hotel | SAN DIEGO, CA 

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Cambridge Healthtech Institute’s 3rd Annual
Single-Use Technologies and Continuous Processing
Advancing Bioprocessing through Technological Innovation
January 18-19, 2016


While single-use technologies and continuous processing (CP) are still fairly new, their steady increase in popularity and successful adoption for both clinical and commercial manufacture are now highlighting several benefits that make these complementary approaches very attractive options within the biopharma industry. The significant advantages of reduced cost of operation, increased productivity, improved quality and increased flexibility of implementing single-use and continuous processing are currently being met by concerns over the added complexity and process control challenges, contamination risks, scalability and regulatory barriers. While some early adopters have fully integrated these systems, others have taken a more measured approach in retrofitting existing batch purification upstream with continuous or single-use components – creating hybrid systems. As the rate of adoption to fully integrate or create hybrid approaches is poised to increase over the next few years, there is great need to evaluate the risks, challenges, opportunities and strategies for implementing these types of technologies into modern day bioprocessing.

Cambridge Healthtech Institute’s 3rd Annual Single-Use Technologies and Continuous Processing conference once again gathers technology and equipment providers, end users and regulators to discuss innovative approaches to current challenges, update companies on the trends in technology, share case studies on successful implementation and ultimately identify how to derive as much value as possible from these technological advances.

Preliminary Agenda 


STANDARDS AND RECOMMENDATIONS
FOR SINGLE-USE EQUIPMENT AND PROCESS

Wide-Scale Adoption of Single-Use Systems – What Are the Challenges Ahead from the Regulators', Suppliers' and End Users' Perspectives?

Jerold Martin, MSc, Chairman, BPSA BoD and Technology (E+L) Committee

Combining Single-Use Technologies with Flexible Workforce to Maximize Utilization of Manufacturing

Wolfgang Noe, Vice President, Technical Operations, Agensys


RISK MITIGATION STRATEGIES FOR SINGLE-USE TECHNOLOGIES

Implementation Strategies and Challenges for Single-Use at Clinical to Commercial Scale: Integrity Testing, Material Qualification, Handling Risks

Adam Goldstein, MSc, Principal Scientist, Global Technology, Roche/Genentech, Inc.

Extractables from Single-Use Bioreactors and Impact on Cell Culture Performance

Yasser Nashed-Samuel, Ph.D., Principal Scientist, Attribute Sciences, Process Development, Amgen, Inc.

Extractable Study Design and Data Evaluation of Polymeric Product Materials

Ping Wang, Ph.D., Principal Scientist and Senior Manager, Janssen R&D, a Pharmaceutical Company of Johnson & Johnson

Disposable User Requirements and Change Notification

Zhaoli Zhou, Ph.D., Manager and Senior Engineer, Process Technology Group, Manufacturing Technology, Sanofi Pasteur

 

CONTINUOUS PROCESSING: ADVANCES,
CHALLENGES AND IMPLEMENTATION

Continuous Processing – Rewrite of the Rules?

Jay Stout, Ph.D., Executive Director, Center for Biopharmaceutical Manufacturing Sciences, Merck

Challenges and Limitations of Continuous Processing and Use of Disposables

Berthold Boedeker, Ph.D., Chief Scientist, Global Biologics Development, Bayer Pharma AG

 

NOVEL TOOLS AND ENABLING TECHNOLOGIES

Development of a Perfusion System in a Microbioreactor Using Sedimentation as a Scale Down Tool for ATF Perfusion Bioreactors

Steffen Kreye, Scientist, Upstream Process Development, Glycotope GmbH




For questions about the meeting, please contact: 

Kip Harry
Conference Director
Cambridge Healthtech Institute
Phone: 781-972-5454
Email: kharry@healthtech.com 

For partnering & sponsorship information, please contact: 

Companies A-K
Jason Gerardi
Manager, Business Development
Cambridge Healthtech Institute
Phone: 781-972-5452
Fax: 781-972-5470
Email: jgerardi@healthtech.com 

Companies L-Z
Carol Dinerstein
Director, Business Development
Cambridge Healthtech Institute
Phone: 781-972-5471
Fax: 781-972-5470
Email: dinerstein@healthtech.com