Upstream & Downstream Technology Forum - October 1-2, 2014

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October 1 & 2, 2014
Le Meridien Cambridge-MIT, Cambridge, MA

Contact Information:

Kathleen Carullo
Sartorius Stedim Biotech
Phone 800.368.7178, ext. 8320
Phone 631.254.4249, ext. 8320
kathleen.carullo@sartorius-stedim.com

Upstream Technology Forum
 

Downstream Technology Forum
Thursday, October 2, 2014

During the last decade, single-use technologies have dramatically changed our way of developing and making drugs. Driven by a growing pipeline of biopharmaceuticals and cost pressure, more and more companies are adopting single-use bioreactors. Very recently, innovative, highly automated, multi-parallel mini-bioreactor systems are making their way into process development and enable early adoption of QbD strategies in a highly effective and cost-conscious way.

We will introduce the Upstream Technology Forum in North America to stimulate discussions among industry practitioners and experts on innovative concepts, benefits

Within the manufacturing process of a 
biopharmaceutical drug, purification is the highest value adding step. Through technological innovations in this area, experts anticipate significant improvements in the productivity and efficiency of downstream processing to accommodate recent
improvements in fermentation.

The Downstream Technology Forum has been initiated to discuss a modern, integrated approach in bioseparation. During the past five years, hundreds of experts from the industry have accepted Sartorius’ invitation to exchange various ideas in state-of-the-art biomanufacturing.

Agenda
Wednesday, October 1, 2014

Agenda 
Wednesday, October 1, 2014

8:30 | Registration

9:00 | Welcome & Opening Remarks
Thomas Cortopassi, Director Fermentation
Technologies, Sartorius Stedim Biotech

9:15 | Lecture 1: Keynote
Cell Culture bioreactor design and scale up
(bridging the gap between traditional and novel design)
Parviz Shamlou, Ph.D., Director of Amgen
Bioprocessing Center,
Keck Graduate Institute of Applied Sciences

10:00 | Lecture 2
Alteration of Glycan Distribution within a
Bioreactor Design of Experiments
Erik K. Read, Ph.D. Senior Staff Fellow, Ofc
Biotech, U.S. Food and Drug Administration

10:45 | Coffee Break

11:15 | Lecture 3
Optimization of the BEVS Platform for the
Production of Scalable High Titer Clinical Grade Recombinant Adeno-Associated Vectors: Multiple Cloning Solutions to Improve Yield
Mahajoub Bello-Roufai, Ph.D., Upstream
Manufacturing and PD Manager,
Florida Biologix

12:00 | Lunch

1:30 | Technology Update
Sartorius Stedim Biotech

2:00 | Lecture 4
Biopharmaceutical Process Carbon Footprint
Modeling: Upstream Considerations
Matthew Snyder, Senior Project Manager,
Glaxo-Smith Kline

2:45 | Coffee Break

3:15 | Lecture 5
Towards Rapid and Robust Cell Culture Process
Development
Shahid Rameez, Ph.D., Senior Scientist, Process
Development, KBI Biopharma, Inc.

4:00 | Lecture 6
Cell Culture Process Development for a Novel
Bispecific Antibody, Benjamin Wang, Ph.D.,
Associate Principal Scientist,
Merrimack Pharmaceuticals

4:45 | Closing Remarks

5:00 | Reception

8:30 | Registration

9:00 | Welcome & Opening Remarks
Francis Bach, Director Purification Technologies
Sartorius Stedim Biotech

9:15 | Lecture 1: Keynote
Downstream Bioprocessing of Protein Therapeutics Current Trends and Future Directions
Ganesh Vedantham, Director of Manufacturing, Amgen

10:00 | Lecture 2
The use of UVC for Viral Inactivation in a VLP
Vaccine Manufacturing Process
Todd Talarico, Vice President of Manufacturing,
Medicago

10:45 | Coffee Break

11:15 | Lecture 3
Industrial Scale Manufacturing of Norovirus VLPs using Disposable Sartobind S Capsules
Ross Taylor, Associate Director,
Process Development,Takeda Pharmaceuticals

12:00 | Lunch

1:30 | Technology Update
Sartorius Stedim Biotech

2:00 | Lecture 4
A Paradigm Transition, Virus Removal Filtration at Pfizer, Dan LaCasse, Principal Scientist, Pfizer

2:45 | Coffee Break

3:15 | Lecture 5
Multivariate Studies to Support Modular Viral
Clearance for AEX Chromatography
Scott Lute, Biologist,
U.S. Food & Drug Administration,
CDER/OPS/DMA

4:00 | Lecture 6
Evaluation of HCP Reduction using Depth Filters and Membrane Absorbers: A Case Study
Kip Brooks, Principal Scientist, Emergent

4:45 | Closing Remarks

5:00 | Reception

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