A key requirement for automated cell therapy manufacturing is to ensure the system is fully closed. A closed system ensures consistently the quality of the cell product, but more importantly, the ability to work in lower classified space without requiring operators to move in and out of biosafety cabinets, thereby reducing labor.
To validate that the end-to-end workflow of the Cocoon Platform is fully closed, our scientists have run accelerated Cocoon® manufacturing processes in a unclassified space. The information presented here demonstrates that a representative Cocoon® process is able to be performed aseptically by performing an Aseptic Process Simulation (APS) to satisfy regulatory requirements.
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