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.

Cluster Engine Flemingsberg – ERDF Project for Growth in Life Science

Flemingsberg is taking a significant step towards establishing itself as a central player in Life Science with the launch of the “Cluster Engine Life Science Flemingsberg” project. The project has been granted funding from the European Regional Development Fund and aims to strengthen the growth and establishment of small and medium-sized enterprises (SMEs) within the life science sector in the Stockholm region. The total project budget is €10.8 million for the years 2025–2027.

BioLamina Establishes Operations in Flemingsberg – A Key Player in ATMP Development

As the world’s first and only producer of laminins, the biotechnology company BioLamina has expanded its operations and chosen to establish part of its business in Flemingsberg. Using laminins, a protein that creates an optimal environment for cells to expand and/or differentiate, they are a key player in the development of ATMPs (Advanced Therapy Medicinal Products) in Sweden and globally.

BIO-Europe – A Conference for Future Medical Innovations

BIO-Europe is Europe’s largest partnering conference for the biotechnology, pharmaceutical, and life science industries. The conference serves as a meeting place where companies, researchers, investors, and other stakeholders in the industry can network, establish collaborations, and discuss business opportunities. The event is held annually in various European cities. This year, BIO-Europe took place in Stockholm from November 4th to 6th, where discussions included advanced cell and gene therapies as the medicine of the future.