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.

Steps shaping innovation and growth – Natasha Bank sums up the first year of Life Science Cluster Flemingsberg

A future life science cluster isn’t built in a year – but with a solid foundation and the courage to act, important steps can be taken along the way. In February 2025, we launched Life Science Cluster Flemingsberg: a multifaceted project with powerful, interconnected ambitions – to enable Flemingsberg’s life science cluster to reach its full potential by collaboration and creating the right conditions for the establishment and growth of those who drive innovation – small and medium-sized enterprises – and, in doing so, contribute to the Stockholm region’s leading position within the sector.

Johnny Högberg Summarizes 2025 – A Year of Growth and Collaboration in Flemingsberg

We are most effective and make the greatest impact when we engage our founders and leverage their size, organizations, and influence, and we still strongly believe in this. At the same time, the fact that we have grown as an organization has also made a difference. Today, we are exactly the kind of “two-pizza team” that Amazon founder Jeff Bezos highlights as the most effective. Among other things, we are now running two cluster initiatives and creating a level of engagement, buzz, and content that is noticeable in Flemingsberg and is actually helping to change the area.

Welcome to The Park Novum!

At The Park Novum, you’re met with spacious offices, creative spaces, and a sweeping view over a growing Flemingsberg. Here, entrepreneurs, innovators, and researchers can find a home that not only provides a modern workplace, but also the opportunity to grow together.

2023-06-22T12:09:14+02:00
Go to Top