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.

The Flemingsberg Science Foundation welcomes Angela Hoyer as the new Networks and Event Manager

With a background as a researcher at Karolinska Institutet and experience from academia, industry, and networking, Angela Hoyer, the new Networks and Event Manager at the Flemingsberg Science Foundation, is passionate about developing the life science sector. In her new role, Angela looks forward to creating meeting places where collaborations can grow, while also contributing to Flemingsberg’s continued development as a strong international hub for research and innovation.

A national resource for tomorrow’s treatments – Karolinska ATMP Center is now inaugurated

With a clear message of hope for the future and a powerful spirit of collaboration, the Karolinska ATMP Center in Flemingsberg was inaugurated at the end of August. The center is a collaboration between Karolinska Institutet and Karolinska University Hospital and will serve as a national resource for the production of advanced therapies (ATMPs), where research, clinical trials, and treatments work seamlessly together to deliver groundbreaking therapies to patients.

Meetings That Shape the Future: Flemingsberg Science at Almedalen

In June this year, the foundation took part in the annual Almedalen Week, the world’s largest democratic meeting place for everyone who wants to join the discussions on current societal issues. This year, we had a special focus on Life Science, an area and cluster that has long been a natural part of Flemingsberg, and which is now growing stronger than ever.