Scale Up of Bioprocessing Systems for Purification

In this advanced workshop, acquire an understanding for approaches and tools used in the scale-up of chromatography and tangential flow filtration systems including pumping, piping, support equipment such as bubble traps, and instrumentation. Discussion includes how the scale-up of one processing system impacts the scale-up and operation of upstream and downstream systems. Concepts and tools are reinforced in problem solving sessions. Several different computer-based scale-up models are explained and used in the problem solving sessions. Small teams will scale up a representative downstream purification process from laboratory data. The scale-up involves equipment sizing, system flow determination, facility utilization, and processing economics.

NOTE:Participants are expected to understand the basic separation technologies of chromatography, tangential flow filtration, solid liquid separations, and how to apply them in the problem solving sessions.

Course Directors

David S. Kahn, Engineering Consultant, Eli Lilly and Company

• BSChE, Case Western Reserve University
• Kahn has been involved in recombinant manufacturing for 12 years. He has been the process engineer supporting all areas of the large scale bulk purification from granule isolation to final high performance liquid chromatography, and has been involved in the design and start up of bioprocess plants and in the development and scale up of new products in the pipeline.

Bala Raghunath, Manager Bioprocess Engineering Group, Millipore Corporation

• PhD in chemical engineering/membrane separations, University of Cincinnati
• Manager of the group responsible for the application and process development support and consultation to biopharmaceutical companies in downstream process< operations such as filtration and chromatography. He has been involved in membrane separations for over 16 years. He has been actively involved in applications development, process optimization, process reviews, design, and troubleshooting across a wide spectrum of biopharmaceutical processes.

Monday, May 21

08.30 - 16.00
The Theory and Practice of Chromatography System Scale up

Tuesday, May 22

08.30 - 16.00
The Theory and Practice of Tangential Flow Filtration System Scale up

Wednesday, May 23

08.30 - 16.00
Workshop: Downstream Purification Bioprocessing Scale up From a Laboratory Process

Thursday, May 24

08.30 - 16.00
Completion of the Downstream Purification Bioprocessing Scale-up from a Laboratory Process; and Review of the Downstream Purification Bioprocessing Scale-up from a Laboratory Process developed by each team