Bioprocess Development and Scale-up for Fermentation and Cell Culture

In this ADVANCED workshop, learn about and be involved in the decision making process that is required to move fermentation and cell culture toward manufacturing for a commercial bioproduct. The design decisions made by each workshop team demonstrate the strategic impact of different process design and scale-up routes on clinical and commercialization timelines and on process economics. The impact on the design and the processing facility will be
considered but equipment and facility scale-up will not be the focus. Learn from daily lectures and participation in small teams that apply the information to the development of cell culture and microbial fermentation based processes.

Course Directors

Matt Hilton, Research Fellow, Eli Lilly and Company

• BS, University of Iowa
• MS and PhD, University of Washington, department of microbiology and immunology under Dr. H.R. Whiteley
• Two years postdoctoral in industrial fermentation, MIT, under Dr Arnold Demain
• 18 years of experience with pharmaceutical fermentation process development and scale-up. Projects have included one therapeutic protein now licensed and sold worldwide, two enzymes used in commercial biotech manufacturing, and several other proteins that have not been commercialized. Hilton has worked on proteins expressed by Escherichia coli, Pichia pastoris yeast, and Dictyostelium slime mold.

Frank Olsen, Director, Process Development, Amgen Inc., Colorado

• Advanced European Degree, biochemistry, University of Copenhagen
• Responsible for the coordination of the development of the manufacturing process and involvement in the BLA and European Dossier for activated protein C at Eli Lilly and Company. Previously, he worked at Novo Nordisk in Denmark, initially screening microbes and developing processes for the manufacture of enzymes. He was coordinating the development of acetolactate decarboxylase, an enzyme used for fast maturation of beer, and later he was involved in the set up of mammalian cell culture technology and development of a blood coagulation product based on Factor VII.

Tuesday, May 22
08.30 – 16.30
Review mammalian cell culture process and microbial fermentation processes. Workshops focused on preclinical and early clinical phases of development.

Wednesday, May 23
08.30 – 16.30
Review scale-up issues in mammalian cell culture; scale-up issues in microbial fermentation; and processes and facility design issues to support early to late stage clinical trials. Workshops focused on pilot plant design and the manufacture of pivotal clinical study material.

Thursday, May 24
08.30 – 16.30
Review real world examples of scale-up issues; and process and facilities design issues for the commercial manufacture of a biologic drug. Learn about tools for rapid assessment of facility cost and process economics. Workshop focused on the design of a mammalian cell culture and a microbial fermentation derived commercial manufacturing process. Teams compare and contrast the different approaches used to scale-up a process, and evaluate the impact of time sensitive decisions on manufacturing capacity and process economics.