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. Some key considerations during fermentation and cell culture scale-up will be reviewed, such as oxygen transfer, power input, agitator and impeller design, environmental control, SIP/CIP. Comparisons of different scale up methodologies will be examined, as well as how to use process simulation as a viable tool to assist scale-up.

Additionally, the seminar will discuss how to use Design of Experiment (DOE) to access the optimum culture characteristics as part of the PAT initiative. Topics such as 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 will also be discussed. Case studies will be presented, 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

• 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 use Design of Experiment (DOE) to assess key culture characteristics
• 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. Learn about heat and mass transfer (KLa), instrumentation, scale-up consideration associated with disposable technology
• Fermenter and bioreactor impeller design and scale-up
• Common design concerns with large scale fermentors and bioreactors
• How to use process simulation as a tool for scale-up and capacity optimization
• How to integrate large scale fermentors and bioreactors with facility design
• Regulatory compliance and process validation for issues for large scale facilities
  
  
  

Who Should Attend
This seminar should be useful for process engineers, research and development scientists, validation engineers, project managers, manufacturing technicians, biologists, or chemists with 1-4 yrs of experience in process development, research, engineering, validation, manufacturing, etc.

Expert Panel:

• DIRECTOR: Wei Huang, VP, Process Development & Engineering, LS9 Inc.
• Dr. Sy-Dar Wang, Chief Technology Officer, AdImmune
• Dr. Steven Meier, Senior Engineer, Genentech
  
• Paul Kubera, Vice President, Technology, ABEC
• Dr. Brian Lee, President and Co-founder, PBS Biotech, Inc.
  
  

AGENDA

             REGISTER NOW! Visit www.asmeconferences.org/Bioprocess08

ASME Travel Policy : ASME is not responsible for the purchase of non-refundable airline tickets or the cancellation/change fees associated with canceling a flight. Please call to confirm that the course is running before purchasing airline tickets. ASME retains the right to cancel a course up until 3 weeks of the scheduled presentation date.