Description
This seminar will cover fermentation / cell culture basic theory, various scale-up and scale-down strategies, related equipment / facility design and regulatory compliance issues. The seminar reviews some key considerations during fermentation and cell culture scale-up, such as oxygen transfer, power input, agitator and impeller design, environmental control, SIP/CIP. Comparisons of different scale up methodologies will be discussed, as well as how to use process simulation as a viable tool to assist scale-up. Other discussion topics include: bioprocess design as it relates to the different stages of clinical development, regulatory compliance during scale-up, and the integration of large-scale fermentation and cell culture process design with facility design. Case studies are embedded into the presentations, followed by a half day work shop which will allow attendees to form project teams and to apply knowledge gained directly to simulated process design and scale-up projects.

What you will Learn

• How to identify when to initiate fermentation and cell culture scale-up during the various pre-clinical and clinical phases
• How to scale-up fermentation and cell culture processes during different clinical and commercial stages
• How to establish a basis for comparability during scale-up, including how to apply scale-down systems
• Latest industry trend of disposable reactor, and how to apply the technology to cell culture and microbial fermentation
• Heat and mass transfer (OUR, KLa), instrumentation, scale-up consideration associated with disposable technology
• Fermenter and bioreactor impeller design and scale-up
• Common design consideration associated with large scale fermenters and bioreactors
• How to integrate large scale fermenters and bioreactors with facility design
• Network with industry peers, share knowledge and experience

Who Should Attend
This seminar should be useful for process engineers, research and process development scientists, validation engineers, project managers, manufacturing technicians, biologists, or chemists with 1-10 yrs of experience in process development, research, engineering, validation, manufacturing, etc.

Instructor/Speaker Panel:

• Wei Huang, VP, Process Development & Engineering, LS9 Inc.
• William J. Kelly, Associate Professor, Villanova University
• Paul Kubera, Vice President Engineering, ABEC, Inc.
  
  SCHEDULE
  

REGISTER NOW! Visit www.asmeconferences.org/BioprocessEurope09

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