Date: October 1-4, 2007 (Monday-Thursday)
CEUs: 3.0

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 program 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. The program will also compare different scale up methodologies, 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 are embedded into the program, followed by a half day work shop which will allow attendees to form project teams and to apply knowledge from the class 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 establish a basis for comparability during scale-up, including how to apply scale-down systems
• Fermentor and bioreactor design and scale-up
• Common design concerns with large scale fermentors and bioreactors
• How to use process simulation as tool for scale-up and capacity optimization
• How integrate large scale fermentors and bioreactors with facility design
• Regulatory compliance and process validation for issues for large scale facilities
• Network with industry peers, share knowledge and experience
  

Who Should Attend

This program 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.

Schedule

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.