RegMed XB U(iP)Scale project

Today at NecstGen, we had the pleasure of meeting with Assistant Professor Françoise Carlotti from Leiden University Medical Center to discuss our collaboration within the broader RegMed XB U(iP)Scale project, which recently received funding. A central goal of the RegMed XB Diabetes Moonshot is to leverage induced pluripotent stem cells (iPSCs) to drive forward regenerative medicine solutions for Type 1 diabetes.

Type 1 diabetes is an autoimmune disorder caused by the destruction of insulin-producing beta cells, which impairs the body’s ability to control blood sugar levels. Without proper intervention, this condition can result in severe health complications and severely impact the quality of life for patients. At present, disease management relies on lifelong administration of external insulin via injections or pumps, alongside continuous monitoring of glucose levels. An iPSC-derived therapy has the potential to restore the body’s ability to produce insulin to control blood sugar levels, ultimately rendering external insulin administration obsolete.

The U(iP)Scale project has two main objectives: scaling up the manufacturing of insulin-producing islets derived from iPSCs and improving the design of a first-generation open-delivery device. Building on insights from previous large-scale preclinical and surgical studies, these efforts aim to support the successful translation of this technology into clinical applications.

At NecstGen, our role is to demonstrate the reliable scale-up of stem cell-derived islets, building upon the pioneering research led by Françoise Carlotti’s team. By using bioreactors, we aim to facilitate the scalable manufacturing of regenerative therapies. First, we will undertake technology transfer into the process development laboratories of NecstGen, where our team will collaborate with LUMC to create a cost-efficient manufacturing process resulting in a clinically relevant scale for regenerative therapy.

This project represents a significant step toward creating a sustainable and scalable source of insulin-producing cells, providing renewed hope for people living with Type 1 diabetes.

Partners: Leiden University Medical Center, Maastricht University, NecstGen, DON, Diabetesfonds

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NecstGen is a non-profit CDMO and Centre of Excellence for Cell and Gene Therapy located in a purpose-built GMP facility in Leiden, The Netherlands. Dedicated to the field of Cell and Gene Therapies, we provide expertise and capacity.

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