This morning, we officially launched the IPCEI-P-SMaRT project, a collaboration between NecstGen, LUMC, NTrans Biotechnologies B.V., and Divvly, supported by IPCEI Med4Cure. This initiative will advance gene editing and gene therapy production platforms, strengthening Europe’s position in cell and gene therapy manufacturing.
A big thank you to our speakers for their insights:
🔹 Paul Bilars (NecstGen) – Welcome and introduction to the project and its ambitions.
🔹 Karla van Rooijen (VWS, Director of Medicines & Medical Technology) – The government’s perspective on the role of advanced therapies in healthcare.
🔹 Niels Geijsen (LUMC) – Presentation on the non-viral CRISPR/Cas9 gene editing production platform, a flagship project.
🔹 Frank Staal (LUMC) – Insights into the lentiviral vector gene therapy production platform, another key initiative within the project.
The future of cell and gene therapies is patient-centered, transforming how we approach medicine. With pioneering research from experts like Frank Staal, gene therapies are progressing from experimental treatments to lifesaving solutions for individuals with severe genetic disorders.
By focusing on scalable manufacturing and clinical application, these therapies have the potential to shift from rare disease treatments to broader applications, ultimately reshaping healthcare by providing personalised, curative therapies rather than lifelong disease management.
We concluded the morning with a tour of NecstGen’s cleanrooms, where we explored the high-tech facilities that will play a crucial role in the project. Seeing the state-of-the-art manufacturing environment firsthand sparked engaging discussions on the future of gene therapy production and how we can accelerate the journey from research to real-world impact for patients.
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
Leiden, the Netherlands, October 8, 2024 – OogFarma has entered into a strategic partnership with NecstGen, a non-profit Contract Development and Manufacturing Organisation (CDMO), to rent cleanroom facilities to support its distribution of Ophthalmic Therapies utilising its innovative syringe system. This partnership focuses on making essential treatments for macular degeneration more affordable, thereby reflecting the shared mission of both organisations.
OogFarma’s simple mission is to deliver high quality ready-to-use anti-VEGF treatment as safely and efficiently as possible, directly to healthcare professionals. Their pre-filled syringes are designed to eliminate waste and unused- or ‘residual’- volume. This makes for a cost-effective solution, that also eliminates the need for preparations steps at point of care, potentially improving patient safety.
The pre-filled syringe is particularly effective for administering small doses, which, in this case, is anti-VEGF treatment essential for patients with macular degeneration, an eye disease.
NecstGen’s advanced GMP-compliant Grade B cleanrooms and facilities provide OogFarma with the end-to-end processing environment it requires. Training and support activities will be provided by NecstGen’s team, and these are shaped by the requirements and feedback of OogFarma. This collaboration is about more than cleanroom rental; it is about creating a shared solution to deliver affordable therapies.
“We had an idea of what we wanted to create—requiring the right facility, quality systems, logistics, inhouse QC, and good documentation practices,” said Bart-Jan Thies, CEO of OogFarma. “NecstGen offered a true plug-and-play solution, like a GMP-train ready to board, providing everything we needed, including essential training. We are particularly pleased with NecstGen’s state-of-the-art facility, which is qualified and validated to meet the latest standards, ensuring a seamless process.”
In the partnership, the syringes are used for ophthalmic treatments; however, future potential uses may include Gene Therapy, which is commonly used to deal with small-volume, costly goods. OogFarma and NecstGen are committed to reducing the barriers to advanced treatments, making a difference for patients who need them the most.
“At NecstGen, our mission is to support those making treatments accessible and affordable,” said Paul Bilars, CEO of NecstGen. “Our partnership with OogFarma helps to address the challenging cost of goods in healthcare, ensuring that an innovative solution can be utilised to better serve the patients who need treatments. By enabling technologies like this syringe, we aim to help create a future where advanced, quality healthcare is accessible to all.”
About OogFarma
OogFarma is a new, innovative compounding pharmacy that focuses entirely on ophthalmology.
With the increasing demand for ophthalmic injections, we provide a solution that guarantees quality, safety, and efficiency. We are proud to support the Dutch market with the latest scientific insights and innovative products. By exclusively focusing on ophthalmic treatments, we aim to deliver the best care to both ophthalmic specialists and their patients.
“Ophthalmic injections are our specialization. Patient safety and quality are our foundation.”
About NecstGen
NecstGen is a non-profit CDMO and centre of excellence for Cell and Gene Therapy, located in a purpose-built GMP facility at the Leiden Bio Science Park, the largest bio-cluster in the Netherlands. NecstGen provides critical contract development, manufacturing, and rental services to academic and industrial therapy developers to deliver next-generation therapeutics to patients.
NecstGen offers:
Full contract manufacturing services for Cell Therapy and Viral Vector development and manufacturing
Process design, scale-up, optimisation, and automation for Cell Therapy and Viral Vector
Assay development for in-process, release, and potency testing
Cleanroom rental, including services for QA, QC, and QP.
We are happy to announce the launch of NecstGen’s first development laboratory at the Leiden Bio Science Park.
Here, our scientists and analytical experts have started the first process development projects, supporting our clients to bring cell- and viral vector-based therapies to patients. This is another step towards realising NecstGen’s mission to accelerate the development of breakthrough cell and gene therapies.
Meanwhile, NecstGen is well underway in the establishment of its GMP facility at Mirai House, which is expected to open its doors in 2022.
Johan Hyllner joins strategic advisory board of NecstGen
NecstGen announces the addition of Johan Hyllner to its strategic advisory board. Johan Hyllner is leading expert in cell therapy and enabling technologies. He is professor of engineering biology at Linköping University, Sweden and head of the Cell Therapy BioPharmaceutical R&D at AstraZeneca. He was responsible for building five startups, including Cellartis and Cellectis, in the cell therapy field into successful international businesses.
“I am excited to join NecstGen’s advisory board. Cell and gene therapies offer great potential to provide something better than existing medicines. It is important to promote this next generation of medicines. NecstGen does this by actively supporting the first steps of their manufacturing. This will ultimately help combat some of the most complex diseases.” Says Prof. Hyllner.
Johan Hyllner obtained his doctorate at the University of Gothenburg. He is devoted to both scientific and industrial aspects of cell therapy, publishing over 60 peer reviewed articles in this field. Since 2012, he is adjunct Professor of engineering biology at the department of Physics, Chemistry and Biology at Linköping University, Sweden. Throughout the last 20 years, Johan was a C-level executive in five startup companies in the cell therapy field and built these into successful international businesses. Among others, as CSO, he has been part of building Cellectis, Cellartis, SQC Lab and Vitrolife into thriving entities. From 2013 he held the position as CSO of the Cell and Gene Therapy Catapult Ltd, London, a high-profile innovation centre established by the British government, where he helped grow the organization from 12 to 170 people. In 2019, he joined AstraZeneca, where he is leading Cell Therapy BioPharmaceuticals R&D. Here, he is responsible for the discovery and development of cell therapy based projects from discovery to clinic across cardiovascular, renal, metabolic, respiratory and immunological diseases. In this role, he oversees the strategic direction of this newly-formed department while building capabilities both internally and through collaborations. Prof. Hyllner brings vast experience in applied research through development to global marketing, manufacturing and commercialization of advanced cell-based products. In addition, he has extensive experience of strategic outlining and execution, external scientific relations, assessment of candidate projects and technical oversight of preclinical programs.
NecstGen contracts Kuijpers for the construction of its Cell and Gene Therapy facility
NecstGen announces that the Dutch constructor Kuijpers has obtained the contract for the construction of its Cell- and Gene Therapy facility. Throughout the next year, NecstGen’s facility will be constructed in Mirai House on the largest Life Science and Health hub of The Netherlands, the Leiden Bio Science Park. Kuijpers is specialised in the design and construction of cleanrooms and GMP facilities. As main contractor the company will be responsible for technical installations and construction.
“We are pleased with the collaboration with Kuijpers, and look forward to a successful construction trajectory. This brings us one step closer to realizing our mission – to bring more regenerative therapies, faster to the patient,” comments Paul Bilars, CEO of NecstGen.
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.
