NorthX Biologics is entering a long term collaboration with Diamyd Medical and APL to support the preparation of retogatein (rhGAD65) for commercial manufacturing. Retogatein is being developed as a therapy aimed at preserving insulin producing cells in people with type 1 diabetes. The collaboration strengthens Sweden’s ability to produce advanced biologics at a time when demand for high quality local manufacturing continues to grow.
“This is a natural next step in work that has been built up over time,” says Ulf Hannelius, CEO of Diamyd Medical. “By combining Diamyd Medical’s in house drug substance manufacturing with APL’s long standing fill and finish expertise, and now adding the validation capabilities of NorthX Biologics, we are creating a sustainable structure for continued development while strengthening Sweden’s manufacturing capabilities within biologics.”
As Diamyd Medical moves closer to commercialization, NorthX Biologics will take responsibility for the work needed to characterize and validate the drug substance process. This includes planning validation steps, managing documentation, and ensuring the process meets regulatory requirements during scale up.
With more than 30 years of GMP experience, NorthX Biologics brings a collaborative and solution focused way of working shaped by our Beyond mindset. We work closely with partners, offering scientific expertise and practical support that make the transition toward large scale production smooth and reliable.
“Our collaboration with Diamyd Medical has developed step by step. We view this as a long term partnership focused on quality, flexibility, and meeting the higher regulatory requirements of later development phases and commercial manufacturing,” says Erik Haeffler, CEO of APL.
“We are excited to be part of Diamyd Medical’s journey to develop retogatein. Our role is to contribute with manufacturing experience, validation and regulatory readiness as the process matures,” says Janet Hoogstraate, CEO of NorthX Biologics. “This partnership is designed to evolve over time through close dialogue, and it helps reinforce Sweden as a strong base for biopharmaceutical manufacturing.”
Together, Diamyd Medical, APL and NorthX Biologics form a complete manufacturing chain covering drug substance production, fill and finish, validation and preparation for commercial supply. This structure reduces risk and creates a more predictable path toward future scale up.
NorthX Biologics aims to contribute to faster progress for retogatein by ensuring that the manufacturing process is robust, compliant and ready for the next stage. The goal is to support future access to a potential therapy for people living with type 1 diabetes.
About NorthX Biologics:
NorthX Biologics is a leading contract development and manufacturing organization (CDMO) and Sweden’s national innovation hub for advanced biologics, enabling next-generation therapies beyond traditional manufacturing. With over 30 years of GMP experience, NorthX Biologics offers end-to-end services including process development, recombinant proteins, vaccines, personalized medicine, viral vectors, cell therapies, and aseptic fill & finish. With its headquarters in Matfors, Sweden, and a facility in Stockholm, NorthX Biologics serves customers worldwide.
https://www.nxbio.com/https://www.nxbio.com/
For more information, please contact:
Janet Hoogstraate
Chief Executive Officer
E-mail: janet.hoogstraate@nxbio.com
About Diamyd
Diamyd Medical develops precision medicine therapies to prevent and treat type 1 diabetes. Retogatein (rhGAD65) formulated with alum is an investigational antigen-specific immunotherapy, designed to induce antigen-specific immune tolerance to GAD65 and preserve endogenous insulin production in individuals with type 1 diabetes who carry the HLA DR3-DQ2 gene. Retogatein has been granted Orphan Drug Designation in the U.S. as well as Fast Track Designation by the U.S. FDA for the treatment of Stage 3 (clinically diagnosed symptomatic) type 1 diabetes. Fast Track Designation has also been granted for the treatment of Stage 1 and 2 (pre-symptomatic) type 1 diabetes. DIAGNODE-3, a confirmatory Phase 3 trial with potential for an accelerated approval pathway in the US, is being conducted at 57 clinics in eight European countries and in the US in patients with recent-onset (Stage 3) type 1 diabetes. Significant results in preserving endogenous insulin production have previously been shown in a large genetically predefined patient group – both in a large-scale meta-analysis as well as in the Company’s prospective European Phase 2b trial. The DIAGNODE-3 trial has only included patients from this specific patient group that carries the common genotype known as HLA DR3-DQ2, which constitutes approximately 40 % of patients with type 1 diabetes in Europe and the US. A biomanufacturing facility is under development in Umeå, Sweden, for the manufacture of retogatein (recombinant GAD65 protein), the active ingredient in the antigen-specific immunotherapy. Diamyd Medical is a major shareholder in the stem cell company NextCell Pharma AB and in the artificial intelligence company MainlyAI AB.
Diamyd Medical’s B share is traded on Nasdaq First North Growth Market under the ticker DMYD B. FNCA Sweden AB is the Company’s Certified Adviser.
For more information, please contact:
Ulf Hannelius,
President and CEO
Phone: +46 736 35 42 41
E-mail: ulf.hannelius@diamyd.com
About APL
Apotek Produktion & Laboratorier (APL) is one of Europe’s leading companies manufacturing extemporaneous drugs and stock preparations. We have a public policy assignment from the Swedish government, but also work together with other pharmaceutical companies to create the greatest possible patient benefit. The assignment also comprises preparedness to maintain operations in times of crisis and ultimately war.
Our vision is that we will make a difference for patients with additional needs. We are also an established contract manufacturer within life science in Scandinavia, where we deliver services within development and analysis. With more than 500 employees and five manufacturing units in Malmö, Gothenburg, Stockholm and Umeå, we develop drugs that improve and save lives.
For more information, please contact:
Erik Haeffler, VD
erik.haeffler@apl.se
