Preliminary Program subject to change
T5003 Strategies in Biopharmaceutical Scale-up & Pilot Plants
OverviewWhile reducing the timelines to market is still a challenge, adopting efficient scale-up and technology transfer strategies in the biopharmaceutical industry is critical. In this race to commercialize new technology, or to improve existing technology, it is widely accepted that pilot plants play a key role in the overall process development scheme. Therefore, this session is particularly interested in topics that include, but are not limited to, scale-up approaches and troubleshooting for upstream and downstream processes, unique technology transfer strategies, design and operation of pilot plants, case studies on processes that are scaled-up in pilot plants that demonstrate a unique team approach and delivery under aggressive timelines and budget limitations.
Primary SponsorTopical 5: Pilot Plant Design and Optimization (T5)
Co-Sponsor(s)Pilot Plants (12b), Pharmaceuticals (See also Topical 2) (15b), Topical 2: Discover, Development and Delivery of Medicines (T2)

Chair

Nihal Tugcu
Research Fellow
BioPurification Development
Merck and Co., Inc.
RY805S-100
126 E. Lincoln Ave. PO Box 2000
Rahway, NJ 07065
Phone Number: 732-594-0495
Email: nihal_tugcu@merck.com

CoChair

Jeanette Beard
Project Engineer
Zeton Inc.
740 Oval Court
Burlington, ON L7L 6A9
Canada
Phone Number: (905) 632-3123 x237
Fax Number: (905) 632-0301
Email: jbeard@zeton.com
Introductory Remarks
Cell Culture Scale-up and Technology Transfer for 12,000 L-Scale Therapeutic Antibody Manufacturing
John Fann1, John Ponzo2, Ziran Sun3, Seshu Tummala3, Clara Teijido2, Min Wan3 and George Avgerinos3, (1)Cell Culture, Manufacturing Sciences, Abbott Bioresearch Center, 100 Research Dr, Worcester, MA 01605, (2)Technical Operations, Barcelonata, Puerto Rico, Abbott Bioresearch Center, 100 Research Dr, Worcester, MA 01605, (3)Technical Operations, Worcester, MA, Abbott Bioresearch Center, 100 Research Dr, Worcester, MA 01605
Strategy to Fit a Downstream Purification Platform for an Early Stage Development, Therapeutic Protein into an Existing Pilot Plant
Francis M. Torres, Bioprocess Clinical Manufacturing & Technology, Merck and Co. Inc., PO Box 4 Sumneytown Pike, WP17 - 301, West Point, PA 19486 and Nguyen V. Ly, Bioprocess Clinical Manufacturing & Technology, Merck and Co. Inc., PO Box 4 Sumneytown Pike, WP17 - 201, West Point, PA 19486
The Role of Process Modeling in Bioprocess Development and Technology Transfer
Charles Siletti, INTELLIGEN, INC., 700 Walton Ave., Mount Laurel, NJ 08054 and Demetri P. Petrides, INTELLIGEN, INC., 2326 Morse Avenue, Scotch Plains, NJ 07076
Multi-Dimensional Model for Prediction and Scale-up of Lyophilization
Pavol Rajniak, Jiri Placek, Joseph Schaller, Rajiv Mahajan and Rey Chern, Merck & Co, Inc., WP78-110, PO Box 4, West Point, PA 19486
Scale up of Fluid Mixing Parameters in Bio-Pharmaceutical Processes
James Y. Oldshue, Oldshue Technologies International, 2250 Gulf Gate Drive - Suite A, Sarasota, FL 34231
From Petrochemicals to Pharmaceuticals: Rapid Scale-up of Penicillin by an Academia-Industry Consortium Including Shell Development Company during World War II
Joseph B. Powell, Chemical Process Technology, Shell Global Solutions US Inc., Westhollow Technology Center, P. O. Box 1380, Houston, TX 77251-1380

Topical 5: Pilot Plant Design and Optimization