XNK Therapeutics AB (“XNK”) today reported the successful completion of the building phase of the company’s new GMP clean room facility.
All equipment and systems are now installed, and qualification of the clean room is complete, while validation and qualification of equipment and systems are progressing according to plan. The first technical batch has been produced in the facility, demonstrating the ability to run a production process.
“XNK has worked hard over the past year planning for this new GMP facility that will enable the aseptic production of ATMPs and clinical material for future studies,” said Paul Do, Head of Clinical Manufacturing and Engineering at XNK Therapeutics. “This is an important step in the company’s ambitious growth plan to enable further larger clinical studies with our natural killer cell-based therapies.”
The GMP facility comprises approximately 350 square meters and includes 150 square meters of clean rooms, quality control (QC) lab, storage for materials and end product, and office space. The facility is located at the Novum research park at Karolinska University Hospital in Huddinge, Sweden.