Alofisel P3 Cell Therapy Facility

CAI was chosen to aid Takeda GC with a faltering Commissioning, Qualification, and Validation (CQV) project at its new Advanced Therapy Medicinal Product (ATMP) manufacturing facility (P3) in Grange Castle. The project was overdue and over budget, with CAI tasked with the qualification of Production Rooms 1 and 2 and their associated process equipment. Despite various issues such as problems with the document management system, vendor commissioning/validation, change management system, and communication, CAI managed to deliver the project on time. This success resulted in CAI securing additional work worth €0.6m and broadening their service offerings to Takeda GC. The P3 facility was the first ATMP facility in Ireland, signifying a significant accomplishment for CAI.