19 February 2025 Leiden, The Netherlands – Modified cells offer an attractive opportunity to cure disease however their inherent complexity requires novel technologies to better understand them. Such technologies could greatly improve Cell Therapy translation and development leading to efficiency and better outcomes for patients.
NecstGen, a non-profit CDMO for Cell & Gene Therapy, and Digi.Bio, a developer of novel lab-on-a-chip technology, have formed a collaboration to improve testing and development for Cell Therapies. This partnership utilises Digi.Bio’s cutting-edge platform to deliver dynamic multiparametric single-cell immunoprofiling, aiming to accelerate the journey from concept to therapeutic.
As the Cell & Gene Therapy industry continues to evolve, the need for more sophisticated development tools and reliable testing methods is critical. Mode of action, efficacy, and safety testing are used to evaluate a therapeutic’s ability to achieve its intended effect and to control risk. Such testing is crucial for the approval and use of Cell and Gene Therapies to treat patients.
Digi.Bio is addressing these challenges with its platform that condenses the typical laboratory processes needed for testing Cell and Gene Therapies into a single microfluidic chip. Leveraging automation, microfluidics, AI and machine learning Digi.Bio’s platform achieves real-time analysis of cell-to-cell behaviour, including their interactions, motility, and therapeutic potential. The partnership with NecstGen provides opportunities for the application of Digi.Bio’s technology to Cell and Gene Therapy development and grants NecstGen access to novel technologies with the potential to speed-up Cell & Gene Therapy development.
“We are proud to collaborate with NecstGen. By bringing together their expertise in Cell & Gene therapy development and our innovative technology we aim to set new benchmarks for the Cell & Gene Therapy industry for efficacy and safety testing and support improving patient outcomes globally.”, adds Federico Muffatto, CEO of Digi.Bio.
“At NecstGen, we are supporting novel technologies that have the potential to accelerate Cell & Gene Therapy development,” said Paul Bilars, CEO of NecstGen. “Partnering with Digi.Bio allows us to leverage their cutting-edge technology to further enhance our testing capabilities, ultimately leading to faster and more reliable development of therapies.”
Watch how Digi.Bio’s technology can bring insights to your therapy development:
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.
About Digi.Bio
Digi.Bio is revolutionizing cell therapy development with its AI-driven, lab-on-a-chip platform. Designed for high-content, real-time analysis, the technology enables dynamic monitoring of immunotherapy performance at single-cell resolution. With BSL-2 laboratories at Leiden Bio Science Park and headquarters in Amsterdam, Digi.Bio provides a digital, single-cell representation of immune therapy responses, offering unprecedented spatial and temporal insights into treatment behavior.
Leiden, Netherlands – February 10, 2025 – NecstGen, a leading Contract Development and Manufacturing Organization (CDMO) dedicated to Cell and Gene Therapies, is proud to announce a strategic collaboration with Galapagos NV (Euronext & NASDAQ: GLPG), a biotechnology company with operations in Europe and the U.S. to support decentralized manufacturing of Galapagos’ candidate cell therapy products. The partnership underscores both NecstGen’s and Galapagos’ commitment to advancing innovative therapies and bridging the gap between the translation of research, to large clinical trials, and bring products to patients.
Building on NecstGen’s expertise in GMP-compliant manufacturing and its cleanroom infrastructure, this collaboration will leverage part of its large state-of-the-art facilities to establish robust CAR-T manufacturing on the basis of Galapagos’ innovative decentralized manufacturing platform. The project aims to support decentralised production of CAR-T therapies, increasing accessibility of these potential lifesaving treatments to patients.
Galapagos is building a pipeline of potentially best-in-class candidate cell therapy products in hematological and solid tumors using its innovative decentralized manufacturing platform. This platform is designed to deliver fresh, fit, stem-like early cells in a median vein-to-vein time of seven days, thereby avoiding cryopreservation and eliminating the need for bridging therapy. The first product to be manufactured under the collaboration agreement will be GLPG5101 which targets relapsed/refractory non-Hodgkin lymphoma indications. The collaboration could be broadened to include the manufacturing of additional product candidates in Galapagos’ portfolio.
Under this agreement, NecstGen will use some of its cleanrooms to support manufacturing for Galapagos’ clinical CAR-T programs. NecstGen will collaborate closely with Galapagos’ technical teams to ensure seamless and timely technology transfer and meet high production standards.
Paul Bilars, CEO of NecstGen, commented:
“Our collaboration with Galapagos marks an exciting milestone in the evolution of NecstGen as an organisation and for Cell and Gene Therapy manufacturing. By combining our state-of-the-art infrastructure with Galapagos’ decentralized cell therapy approach, we aim to provide capacity and support for decentralised manufacturing and make transformative therapies more accessible to patients who need them.”
This collaboration builds upon NecstGen’s proven track record further establishing it as a trusted partner and a key player for Cell and Gene Therapy manufacturing.
Galapagos is a biotechnology company with operations in the U.S. and Europe dedicated to transforming patient outcomes through life-changing science and innovation for more years of life and quality of life. Focusing on high unmet medical needs, Galapagos synergizes compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class medicines. With capabilities from lab to patient, including a decentralized cell therapy manufacturing platform, Galapagos is committed to challenging the status quo and delivering results for patients, its employees, and its shareholders. Galapagos’ goal is not just to meet current medical needs but to anticipate and shape the future of healthcare, ensuring that its innovations reach those who need them most. For additional information, please visit www.glpg.com or follow the Company on LinkedIn or X.
About NecstGen
NecstGen is a large non-profit CDMO and center 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 specialises in providing contract development, manufacturing, and consulting services to support academic and industrial therapy developers reach patients.
Leiden, Netherlands — NecstGen, the Netherlands Center for the Clinical Advancement of Stem Cell and Gene Therapies, is proud to announce the successful completion of a consultancy project in collaboration with Dr. Debby Gawlitta from the Department of Oral and Maxillofacial Surgery & Special Dental Care at UMC Utrecht. The project focused on providing a technical and cost analysis of manufacturing options for Dr. Gawlitta’s innovative mesenchymal stromal cell (MSC)-derived spheroid therapy for bone defects.
Dr. Gawlitta’s research has demonstrated promising preclinical results in endochondral bone regeneration using MSC-derived spheroids. To bridge the gap between research and clinical application, this consultancy project assessed the feasibility and scalability of Good Manufacturing Practice (GMP) production for the therapy, offering insights into technical requirements, cost considerations, testing strategy, and potential pathways to clinical implementation.
Paul Bilars, CEO of NecstGen, highlighted the significance of the project:
“This consultancy project underscores our commitment to supporting innovators like Dr. Gawlitta in overcoming the technical challenges of advancing groundbreaking therapies. By offering tailored advice on manufacturing strategies, we aim to accelerate the translation of promising research into impactful patient treatments.”
Dr. Gawlitta expressed her appreciation for the collaboration:
“The consultancy provided by NecstGen has supported shaping the next steps for our therapy. Their expertise has clarified the technical and cost-related aspects of GMP manufacturing, enabling us to make informed decisions as we move toward clinical translation. With this foundation, we are better positioned to bring our bone regeneration therapy closer to reality.”
This project was supported by a RegMed XB/Dutch Cardiovascular Alliance Thematic Tech Transfer Voucher, which enabled the partnership and facilitated the evaluation of manufacturing options for this promising therapy.
About NecstGen NecstGen is a non-profit CDMO and center 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 specialises in providing contract development, manufacturing, and consulting services to support academic and industrial therapy developers.
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.
Rotterdam and Leiden, Netherlands, July 17, 2024 – NecstGen, a non-profit CDMO, and Pan Cancer T, a company developing a TCR-T cell product (PCT1:CO-STIM) for the treatment of triple negative breast cancer, announce further projects.
This new agreement with Pan Cancer T builds directly on the solid foundation established in previous collaborations between both organisations. Following a successful technology transfer and proof-of-concept scale-up, both parties are happy to announce that more activities will be performed by NecstGen at its state-of-the-art facility for Cell and Gene Therapy development and manufacturing located in Leiden.
Rachel Abbott, CEO, Pan Cancer T commented, “Successfully completing our latest funding round will accelerate our path to the clinic and treating patients. CMC development is a critical component to realising this ambition. We recognise in NecstGen a partner committed to reducing the costs of development and manufacturing whilst maintaining commitment to quality.”
The companies will continue to undertake the process and analytical development of Pan Cancer T’s novel Cell Therapy. Led by Melissa van Pel, Head of Cell Therapy, NecstGen will utilise its large equipment portfolio and expert team to progress the process and assays required for PCT1:CO-STIM to be successfully manufactured.
This continued collaboration demonstrates NecstGen’s capability to scale and enhance processes as its partnerships evolve to enable bridging early research and clinical applications, including GMP manufacturing.
Paul Bilars, CEO, NecstGen, said, “I am delighted with my team’s performance in our partnership with Pan Cancer T to date, demonstrating what NecstGen can contribute to organisations in Cell and Gene Therapy. NecstGen now routinely receives feedback that we are offering partners a competitive cost basis. This is core to our vision as an organisation. Maximising the budget of all organisations involved in Cell and Gene Therapy will accelerate therapies reaching patients and benefiting society.”
About Pan Cancer T
Pan Cancer T was founded in late 2020 as a spin-off from Erasmus MC (Rotterdam, the Netherlands) to advance next generation TCR T cell therapies for hard-to-treat solid tumors. The Company’s approach includes two differentiating elements. First, it exploits unique targets for T cells that are exclusively and robustly expressed by multiple solid cancers. Second, it develops technologies that enhance the durability of the T cells. The Company has ongoing R&D programs to develop safe and effective adoptive T cell therapies amenable to large cohorts of patients with triple negative breast cancer as well as cancers of the bladder, ovarium, colorectum, prostate, skin, esophagus, lung, or brain. For more information, please visit: www.pancancer-t.com
About NecstGen
NecstGen is a new centre of excellence for Cell and Gene Therapy, located in a purpose-built GMP facility on the largest bio-cluster in the Netherlands, Leiden Bio Science Park. Here, NecstGen provides critical contract development, manufacturing and rental services to academic and small/large industrial therapy developers to deliver a new generation of therapies to patients. For more information visit www.necstgen.com.
For more information please contact:
Pan Cancer T
Marconistraat 16 3029 AK, Rotterdam The Netherlands
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.
