Monday, July 27, 2009 - 3:30 PM
S39
Strategies to Ensure a Successful Transfer of a Mature Cell Culture Process
Kate Bishop, Global Manufacturing Sciences and Technology, Genentech Inc., 1 DNA Way, Mail Stop 208A, South San Francisco, CA 94080
The introduction of a manufacturing process into a new facility is always a complex endeavor; transferring a mature product poses several unique challenges that should be addressed to ensure success.
A specific case study will be reviewed outlining the strategy used by Manufacturing Sciences (process donor) to transfer a mature process from one GMP manufacturing facility (Facility A) to another (Facility B). The strategy includes the following components:
• Retrospective data analysis of full-scale process data at Facility A
• Preparation of a risk mitigation plan to address any potential differences
• Employ a conservative approach to the implementation of any changes at Facility B
• Detailed experimental plan to investigate known differences due to facility fit considerations
• A pre-established functional scale-down model of the cell culture process for troubleshooting at Facility B during and after process transfer
• Execution of Engineering Runs to enable opportunity for fine-tuning of process operation before initiation of GMP runs
Full-scale cell culture performance data from the process run at Facility B compared against established expectations from Facility A will be shared. Strategies for risk mitigation and performance monitoring will also be discussed.
A specific case study will be reviewed outlining the strategy used by Manufacturing Sciences (process donor) to transfer a mature process from one GMP manufacturing facility (Facility A) to another (Facility B). The strategy includes the following components:
• Retrospective data analysis of full-scale process data at Facility A
• Preparation of a risk mitigation plan to address any potential differences
• Employ a conservative approach to the implementation of any changes at Facility B
• Detailed experimental plan to investigate known differences due to facility fit considerations
• A pre-established functional scale-down model of the cell culture process for troubleshooting at Facility B during and after process transfer
• Execution of Engineering Runs to enable opportunity for fine-tuning of process operation before initiation of GMP runs
Full-scale cell culture performance data from the process run at Facility B compared against established expectations from Facility A will be shared. Strategies for risk mitigation and performance monitoring will also be discussed.