University of Maryland BioPark
801 West Baltimore Street, Baltimore, MD, 21201 

Cell therapy and regenerative medicine technologies require strict cell manufacturing procedures to be defined and addressed. Maintenance of the aseptic environment is critical to preclude extrinsic contamination risks, similar to conventional pharmaceutical manufacturing. Intrinsic contamination risks exist in all cell manufacturing processes owing to the use of cells as the raw materials, which cannot be sterilized, thus giving rise to primary and secondary risks of cell contamination and cross-contamination, respectively. 

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 high priority.A proactive contamination control mindset is critical. 

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