After an intensive spring with preparation, planning, procurement, and design, the groundwork was laid for constructing a GMP facility that enables the aseptic production of ATMPs and clinical material for future studies.
The GMP facility comprises approximately 350 square meters and, in addition to 150 square meters of clean rooms, also houses a quality control (QC) lab, storage for materials and end product, and office space. The facility will be located at the Novum research park at Karolinska University Hospital in Huddinge, Sweden – an excellent centre for medical research and an ideal location for XNK’s plans.
A clean room graded R&D lab will also be built in connection with the production premises. Together with existing R&D labs, it will increase R&D capacity and the opportunity to work with additional indications.
The cleanrooms are built by Caverion, a well-known and reputable contractor who has built and delivered clean rooms to the pharmaceutical industry for more than 30 years.
The cleanrooms are designed to comply with ISO 14644 class 7-9 and EuGMP classes B, C, and D. The room environment will be monitored by an FMS (Facility Monitoring System), which ensures the proper conditions aseptic manufacturing.
The GMP facility will also have remote control solution that enables monitoring of the cell culture process outside the cleanrooms, which provides increased control, security of production, and quality of the product.
In parallel with the construction, intensive work is underway to complete the Tech Transfer and procedures for applying for manufacturing permits for the new GMP facility.
The validation of the GMP facility is expected to be completed during the first half of 2022, while the QC and R&D labs are expected to be operational in Q1 2022.
When the GMP facility is ready, XNK will have complete control over the entire development chain, from R&D to the production of clinical material, which is critical for meeting the company’s ambitious growth plans.
For more information, please contact:
Johan Liwing, CEO, XNK Therapeutics
Tel: +46 706 70 36 75
About XNK Therapeutics AB
XNK Therapeutics is a clinical stage, immunotherapy company focusing its efforts on preventing and treating cancer by developing novel NK cell-based therapies. The company has established a leadership position in the clinical development and manufacture of autologous NK cell-based products using its proprietary technology platform. The company’s platform technology and leading investigational drug candidate have ideal properties for targeting cancers, including settings where allogeneic cell products are not readily applicable. It is foreseen that the product will bring a critical component to tomorrow’s cancer treatment strategies. XNK Therapeutics is headquartered in Stockholm, Sweden. For more info, please visit http://www.xnktherapeutics.com.
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