The goal of contamination control in cell-based product manufacturing should be to map out the whole process and understand the risks for each step in the manufacturing operation.  A comprehensive view of all of these elements, and anywhere there’s an opportunity to mitigate contamination risk, including automation, is critical. Potential detrimental effects on the microbiological safety of any cell-based products should be considered as a high priority and a proactive contamination control mindset is essential.

This one-day fast track intensive workshop will cover contamination issues from facility design to product release and how to develop a contamination control strategy. This will address, ATMP Guidance, EU Annex 1, EU Annex 2, FDA’s Aseptic Guidance and more.

Which industries does this workshop apply to?

Cell Therapy, Gene Therapy, Tissue Banks and Wound Care products using live cells

Who will benefit?

Quality, Manufacturing, Research and Development, Facilities, Microbiology and Operators 

Event Overview

• Commonly encountered facility challenges
• In-coming materials
• Extrinsic contamination
• Disinfection challenges
• Human borne contamination
• Contamination detection
• Testing challenges