XNK Therapeutics today announced that it has received a GMP manufacturing license and a certificate of GMP compliance from the Swedish Medical Products Agency, which means that the company can produce at scale for its planned clinical studies.
“We are very happy to receive this license. It is an important milestone for XNK, and we are now well positioned for significant value creation with three to four potential phase I/II readouts in our pipeline over the coming three years. The in-house GMP facility provides us with valuable capacity, flexibility and control over our clinical manufacturing which brings competitive advantages going forward. In addition, the close collaboration and proximity between manufacturing and research & innovation ensures efficient process development and organizational learning,” said Johan Liwing, CEO, XNK Therapeutics.
The building phase of the company’s new GMP clean room facility was completed in September 2022. The GMP facility comprises approximately 350 square meters and is located at XNK in the Novum Research Park, co-located with the Karolinska Institutet and the Karolinska University Hospital in Huddinge, Sweden.
“I am proud of the team which has worked hard over the past 18 months to build and validate our new GMP facility and a regulatory compliant Pharmaceutical Quality System. This will enable us of aseptic production of ATMPs for future clinical trials. This is an important step in the company’s ambitious growth plan to enable further larger clinical trials with our natural killer cell-based therapies,” said Linda Brink, Head of QA at XNK Therapeutics.