- NorthX Biologics and Mendus have completed GMP manufacturing certification for the cell therapy vididencel.
- The achievement supports late-stage clinical development and future commercialisation within an established CDMO partnership.
NorthX Biologics, a CDMO and Swedish innovation hub for advanced biologics, and Mendus have announced the completion of GMP manufacturing certification for vididencel, Mendus’ lead cell therapy product. The milestone concludes a two-year collaboration initiated in 2023 to establish scalable, compliant cell therapy manufacturing capabilities in Sweden.
The partnership was designed to support late-stage clinical development and future commercial supply of vididencel, an immunotherapy aimed at reducing tumour recurrence in acute myeloid leukaemia (AML) and other cancers. The project was co-financed by investor Flerie and included adaptation of NorthX Biologics’ facilities for allogeneic cell therapy, full technology transfer and delivery of clinical-grade batches.
“This partnership has gone beyond traditional manufacturing. Through open and transparent collaboration, we’ve built not only a cell therapy infrastructure but also mutual capabilities.”
Janet Hoogstraate, CEO of NorthX Biologics
The companies noted that the milestone demonstrates the maturity of the vididencel process and provides a foundation for Mendus’ clinical advancement in AML and chronic myeloid leukaemia (CML). Mendus CEO Erik Manting stated that reliable manufacturing is central to the company’s go-to-market strategy.
The achievement strengthens Sweden’s position within Europe’s cell and gene therapy landscape and highlights how CDMO collaborations can align development and commercial objectives across the advanced therapy supply chain.
