NorthX Biologics, a leading CDMO and Swedish national innovation hub for advanced biologics, and Mendus, a Swedish-Dutch immuno-oncology company developing cell-based immunotherapies to address tumour recurrence and improve survival outcomes, have announced the successful completion of GMP manufacturing certification for Mendus’ lead cell therapy product, vididencel.
This marks the culmination of a transformative collaboration initiated in 2023, when NorthX Biologics and Mendus entered into a strategic alliance to establish scalable, GMP-compliant cell therapy manufacturing in Sweden. The project, co-financed by life science investor Flerie, was designed to support late-stage clinical development and future commercialization of vididencel, Mendus’ groundbreaking immunotherapy targeting tumour recurrence in AML and other cancers.
“This partnership has gone beyond traditional manufacturing,” said Janet Hoogstraate, CEO of NorthX Biologics.
“Through open and transparent collaboration, we’ve built not only a cell therapy infrastructure but also mutual capabilities. Together, we’ve grown stronger, technically, operationally, and strategically. Achieving GMP readiness and delivering clinical-grade material for Mendus’ upcoming clinical trials is a shared success story rooted in trust and innovation.”
For two years, NorthX Biologics and Mendus have collaborated to adapt NorthX Biologics’ GMP facilities for allogeneic cell therapy production, perform tech transfer of the vididencel process, and manufacture clinical batches in accordance with stringent regulatory standards. The process development and manufacturing journey has reinforced Sweden’s position as a hub for advanced therapy medicinal products (ATMPs) and enabled Mendus to accelerate its oncology pipeline.
“With the establishment of large-scale GMP production, we’re delivering on an important milestone for the vididencel program,” said Mendus CEO Erik Manting.
“Reliable manufacturing is central to advance our clinical trials and go-to-market strategy in AML and CML. This milestone demonstrates the maturity of the vididencel production process and strength of our partnership with NorthX Biologics. It reflects the execution focus that defines Mendus, as we continue to build clinical momentum.”
The successful execution of this manufacturing project positions both companies at the forefront of Europe’s ATMP ecosystem. It also exemplifies how tailored CDMO alliances can unlock clinical and commercial potential for cell therapies by aligning scientific ambition with industrial excellence.
Jim Cornall is editor of Deeptech Digest and publisher at Ayr Coastal Media. He is an award-winning writer, editor, photographer, broadcaster, designer and author. Contact Jim here.