XNK receives certificate of GMP compliance of a manufacturer from the Medical Products Agency

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.

Compete for the Flemingsberg Science Award STARTUP 2025– take your ideas to the next level

Finally, registration for the Flemingsberg Science Award STARTUP 2025 is open. Do you have an exciting business idea that deserves expert testing? Are you ready to take it to the next level? Then this competition is perfect for you. Participate and compete for a prize of 10,000 SEK and three months of membership at Innovation Station – a coworking space, innovation hub, and meeting place in the heart of Campus Flemingsberg.

PARTNERSKAP

At the foundation, we are actively working to strengthen Flemingsberg by fostering partnerships with organizations that share our vision of investing in the area’s operations and future growth. We firmly believe that the more we unite, the stronger we become. That’s why we’ve introduced two types of partnerships, each with its own purpose and function.

Södertörn University Invests in Social Innovation for Youth in Flemingsberg

Södertörn University has announced that they have been granted funding from the Swedish ESF Council to establish a competence center for social innovation. Flemingsberg continues its development as an innovation hub as researchers, students, and various stakeholders engage in efforts to combat social and economic vulnerability among young people in Södertörn.