Contamination Control Strategy for Start-Up Cell Therapy

The availability and regular use in the pharmaceutical industry of advanced aseptic technologies that enables compliant and effective aseptic manufacturing is well understood and documented. With Cell Therapy (CT) manufacturing there is in many cases an element of 'Back to the Future' with the extent of manual aseptic processing involved to deliver the compliant and effective manufacture of leading edge therapies of today. The Takeda (Dublin) cell therapy facility was commissioned in 2019 and received its Manufacturing License from the Health Products Regulatory Authority in 2021. A facility expansion is currently under construction. This is the first approved commercial CT facility in Ireland. This presentation describes the development and evolution with respect to controls effectiveness of a robust contamination control strategy (CCS) from early facility design to commercial manufacturing for the manual aseptic processes. In addition, the presentation will address how the CCS was effectively used to input into the design of the facility expansion currently under construction.