Fujifilm Diosynth Biotechnologies (FDB) sought to “close the loop” by keeping all upstream and downstream aseptic processing operations within closed systems. The missing part was downstream, where FDB implemented a closed robotic filling workcell for manufacturing gene therapies.
Workcells solve long-standing problems with sterility assurance, containment, and process control in aseptic filling. The knowledge developed by FDB during its implementation and early use of a closed workcell can benefit organizations developing new drug products.
Participants will learn about the following topics:
– Transitioning to a fully closed, robotically driven aseptic filling process
– Removing humans from the process for “touchless” filling
– Managing hazard pathways and risks to drug products
– Ensuring “closure by design” for product safety and vial integrity
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