Bioprocess Development for Downstream Purification

Take on this ADVANCED workshop for points to consider and the tools to develop a downstream purification bioprocess. Improve your understanding of the basic biochemical process technology typically used in purification processes for proteins from recombinant hosts. Understand the elements of a process concept, a process control strategy, and a process development strategy. Review case studies where downstream processes will be discussed in detail. Be part of a team solving real world process development problems using the tools from lectures to make choices to derive a purification process.

Participants will be divided into a series of cross-functional teams. Each team solves a series of problems that explore the theory and practice of downstream bioprocess development. Finally each team chooses an approach to develop a bioprocess that fits their
respective project and engage in the planning and design activities for developing a new downstream purification process.

NOTE: Participants are expected to understand the basic separation technologies of chromatography, tangential flow filtration, solid liquid separations, and final API forms and how to apply the principles when developing a process.

Course Director

Fred Larimore, Director of Scientific Affairs, Cook Pharmica

• BA in chemistry, St. Olaf College
• PhD in Biochemistry, University of Minnesota, post doctoral fellowship at Harvard Medical School
• A member of the teams for the scale-up and manufacturing support of human insulin from recombinant E. coli , both the chain and proinsulin routes, human growth hormone, human parathyroid hormone, and several monoclonal conjugates. He also has had positions in project management, management of a protein process development group and management of manufacturing technical support groups. Larimore currently leads a team of development scientists.

Monday, May 21

08.30 – 10.00
Strategies of Process Design and Workshop
Fred Larimore, Director of Scientific Affairs, Cook Pharmica LLC

10.30 – 12.00
Elements of a Control Strategy and Workshop
Fred Larimore, Director of Scientific Affairs, Cook Pharmica LLC

13.00 – 16.0
0 Design of Experimentation and Workshop
Doris Weisman, Sr. Research Statistician, Eli Lilly and Co.

16.00 – 16.30
Process Development Strategy
Fred Larimore, Director of Scientific Affairs, Cook Pharmica LLC

Tuesday, May 22

08.30 – 9.30
Process Development Strategy Workshop
Fred Larimore, Director of Scientific Affairs, Cook Pharmica LLC

9.30 – 11.30
Unit Operations
Roger Brunkow, Director of Technology and Strategy, Cook Pharmica LLC

11.30 – 12.00
Tangential Flow Filtration
Bala Raghunath, Manager, Process Engineering, Millipore Corp.

13.00 – 14.00
Tangential Flow Filtration Workshop
Bala Raghunath, Manager, Process Engineering, Millipore Corp.

14.30 – 16.30
Chromatography and Workshop
Fred Larimore, Director of Scientific Affairs, Cook Pharmica LLC

Wednesday, May 23

08.30 – 10.00
Workshop
Fred Larimore, Director of Scientific Affairs, Cook Pharmica LLC

10.30 – 12.00
Case Study
Fred Larimore, Director of Scientific Affairs, Cook Pharmica LLC

13.00 – 16.30
Process Development Workshop
Fred Larimore, Director of Scientific Affairs, Cook Pharmica LLC

Thursday, May 24

08.30 – 12.00
Process Development Workshop
Fred Larimore, Director of Scientific Affairs, Cook Pharmica LLC

13.30 – 16.00
Process Development Workshop Review
and Summary of Results
Fred Larimore, Director of Scientific Affairs, Cook Pharmica LLC