NorthX Biologics Achieves GMP Certification to Manufacture Vididencel for Leukemias – Paving the Way for Advanced Cell Therapy

Published on December 1, 2025

By: Tuhin Sarkar

NorthX Biologics has achieved a significant milestone with the GMP certification to manufacture vididencel, Mendus’ breakthrough cell therapy targeting acute and chronic myeloid leukemias (AML and CML). This GMP certification ensures that vididencel, an off-the-shelf cellular immunotherapy, is now ready to advance into its late-stage clinical trials.

With this step, NorthX Biologics unites with Mendus in a collaborative effort that accelerates the progress of Mendus’ oncology pipeline. This milestone marks a major turning point in cell therapy development, reinforcing the role of Sweden as a key hub for advanced therapy medicinal products (ATMP).

The successful GMP certification is a key factor in moving this life-changing therapy forward. It highlights the power of strategic partnerships in achieving clinical excellence and provides a clear path to commercialization. This milestone not only demonstrates the capabilities of NorthX Biologics but also underscores the promise of vididencel in treating myeloid leukemias, one of the most challenging forms of cancer.

NorthX Biologics: A Pioneer in Advanced Therapy Manufacturing

NorthX Biologics, headquartered in Matfors, Sweden, has long been a leader in the development and manufacturing of advanced biologics. Known for its expertise in GMP manufacturing, NorthX is at the forefront of providing end-to-end services that include process development, viral vectors, recombinant proteins, and aseptic fill & finish. With over 30 years of experience, the company offers tailored solutions for its partners, which include major biopharma companies working on groundbreaking therapies. NorthX’s state-of-the-art facilities in Sweden and Stockholm enable it to support the manufacturing of next-generation cell therapies, reinforcing its status as a key player in Europe’s ATMP ecosystem.

The GMP certification for vididencel is a testament to NorthX Biologics’ expertise in cell therapy manufacturing. This milestone exemplifies the company’s ability to adapt its facilities for the production of allogeneic cell therapies, ensuring that the highest regulatory standards are met. The collaboration with Mendus highlights the value of tailored contract development and manufacturing organisations (CDMOs), which have become essential for the success of cell-based therapies in the oncology space. The partnership shows how CDMO alliances can accelerate the clinical and commercial journey of innovative therapies.

Mendus: A Rising Star in Immuno-Oncology

Mendus, a Swedish-Dutch immuno-oncology company, has made significant strides in developing cell-based immunotherapies designed to target tumor recurrence and improve survival rates in cancer patients. The company’s lead product, vididencel, is an off-the-shelf cellular immunotherapy designed to treat both acute and chronic myeloid leukemias (AML and CML). This therapy represents a novel approach in immuno-oncology, using the body’s immune system to fight cancer cells.

Vididencel has already shown positive results in Phase 2 proof-of-concept trials, making it one of the most promising therapies in the field of hematologic oncology. The collaboration with NorthX Biologics has been crucial in advancing this therapy towards large-scale production, a critical step as the therapy moves into late-stage clinical trials. The GMP certification marks an essential milestone in Mendus’ journey to bring this transformative therapy to market. The company’s CEO, Erik Manting, emphasized the importance of reliable manufacturing for advancing their clinical trials and go-to-market strategy. This achievement reflects Mendus’ commitment to executing its plans and accelerating its oncology pipeline.

The Power of Strategic Partnerships in Advancing Cell Therapies

The partnership between NorthX Biologics and Mendus highlights the power of strategic collaborations in advancing the development and commercialization of cell therapies. As a CDMO, NorthX Biologics has been able to provide the necessary infrastructure and technical expertise to scale up the production of vididencel, ensuring that the therapy meets the stringent regulatory standards required for clinical trials. This collaboration has gone beyond the traditional manufacturing relationship, with both companies working closely to adapt production processes and share insights.

Janet Hoogstraate, CEO of NorthX Biologics, underscored the importance of open and transparent collaboration, which has enabled both companies to grow stronger technically and operationally. The shared success of achieving GMP readiness and manufacturing clinical-grade material for Mendus is a reflection of the mutual trust and innovation between the two companies. This milestone exemplifies the growing importance of tailored CDMO alliances in the successful development of cell therapies. These partnerships are essential in unlocking the full potential of innovative treatments, providing a clear path for clinical trials and eventual market entry.

Sweden’s Position as a Leader in Advanced Therapy Medicinal Products (ATMPs)

The successful GMP certification for vididencel also strengthens Sweden’s position as a global hub for advanced therapy medicinal products (ATMPs). Sweden has become a key player in the field of cell therapy, with companies like NorthX Biologics and Mendus leading the way. The country’s expertise in biologics, coupled with its strong innovation ecosystem, makes it an ideal location for the development and manufacturing of cutting-edge therapies.

NorthX Biologics has played a significant role in reinforcing Sweden’s position as a leader in ATMP manufacturing. The company’s collaboration with Mendus and other life science investors showcases the country’s commitment to advancing the biopharma industry. As the demand for cell-based therapies continues to grow, Sweden’s infrastructure, expertise, and regulatory environment make it an attractive destination for biopharma companies looking to bring innovative therapies to market.

A Promising Future for Vididencel and the Cell Therapy Industry

The GMP certification of vididencel is a critical step in advancing the therapy through clinical trials and ultimately to market. This milestone brings Mendus closer to its goal of providing an effective treatment for AML and CML, two of the most challenging forms of leukemia. With a reliable manufacturing process in place, Mendus is now ready to scale up production and meet the demand for clinical trials.

As the cell therapy industry continues to evolve, the success of collaborations like the one between NorthX Biologics and Mendus highlights the importance of strategic partnerships in accelerating the development of life-saving therapies. The GMP certification of vididencel serves as a testament to the progress that can be made when companies unite to share expertise and resources. The future of cell-based immunotherapy looks promising, and the successful execution of this project is a major step towards changing the treatment landscape for leukemia patients.