NecstGen

We are excited to announce our partnership with Galapagos to take decentralized CAR-T cell manufacturing in Europe to the next level! Together, we’re breaking new ground to accelerate access to potentially life-changing therapies. Full press release 👇   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."    For more information connect with Tristan Pritchard-Meaker Netherlands Enterprise Agency , Netherlands Foreign Investment Agency, Leiden Bio Science Park, RegMed XB, Leiden University - Institute of Public Administration, Netherlands Society of Gene and Cell Therapy NVGCT

Today Sophia Kolbe attended the RegMed Forum in Berlin, where discussions focused on the critical challenges of process development, GMP readiness, and clinical translation of Advanced Therapy Medicinal Products (ATMPs). With Europe catching up in early-phase ATMP clinical trials, it is essential to strengthen the collaboration between academia, CMOs, and industry to accelerate development and adoption. The day began with Petra Reinke’s keynote on the challenges of translating cell and gene therapies from academic research to the clinic. The breakout sessions on clinical trials, education, and manufacturing provided valuable insights into key bottlenecks, followed by an engaging panel discussion on overcoming GMP facility bottlenecks for ATMP development. Some key takeaways: - GMP remains a major hurdle – early integration of quality and scalability is essential. - Connecting research with industry is essential – academic innovation must align with commercial viability. - Lessons from translation efforts – real-world case studies highlighted what could have eased the process. It was great to connect with the German Cell & Gene Therapy community exploring solutions that will drive ATMPs forward. Thank you to the Berlin Institute of Health, HealthCapital Berlin-Brandenburg, German Stem Cell Network (GSCN), and all organising partners for facilitating this event.

𝐖𝐚𝐭𝐜𝐡 𝐭𝐡𝐞 𝐖𝐞𝐛𝐢𝐧𝐚𝐫 𝐑𝐞𝐩𝐥𝐚𝐲: 𝐢𝐏𝐒𝐂 𝐃𝐢𝐟𝐟𝐞𝐫𝐞𝐧𝐭𝐢𝐚𝐭𝐢𝐨𝐧 𝐟𝐨𝐫 𝐑𝐞𝐠𝐞𝐧𝐞𝐫𝐚𝐭𝐢𝐯𝐞 𝐂𝐞𝐥𝐥 𝐓𝐡𝐞𝐫𝐚𝐩𝐢𝐞𝐬. You can now watch the entire webinar on demand if you missed the live session. In this session, Catalina Gomez-Puerto, PhD shares her knowledge on induced pluripotent stem cells (iPSCs) and their role in regenerative medicine. The discussion covers key aspects of iPSC differentiation, challenges in the field, and real-world applications, including Beta Cells, Dopaminergic Neurons, and RPE Cells. What You’ll Learn in the Replay: – A practical overview of iPSC development and workflows – ⁠Methods and approaches for guiding iPSCs into specific cell types – Case studies on iPSC-derived cell therapies – An update on current clinical advancements If you have additional questions, we invite you to share your questions! Watch the replay here: https://lnkd.in/g-tymFUP

Are you ready? Catalina is! In about half an hour, we'll start our webinar on how induced pluripotent stem cells (iPSCs) are being developed into potentially life-changing therapies! What's in this webinar? Our colleague Catalina Gomez-Puerto, PhD will share her expertise on iPSC-derived cell therapy development. She will discuss opportunities and challenges of iPSC differentiation and showcase practical applications with case studies. The webinar will: 👉 Provide a practical overview of the development and workflow of iPSCs. 👉 Share insights on methods and strategies for the differentiation of iPSCs into specific cell types. 👉Highlight case studies of iPSC differentiation into Beta Cells, Dopaminergic Neurons, and RPE Cells. 👉 Give a valuable summary on the current clinical landscape of iPSC-derived cell therapies. Don’t miss this chance to explore the potential of iPSCs for regenerative cell therapies. Join us in 30 minutes: https://lnkd.in/ebPwHbzi

We're excited that NecstGen and Digi.Bio announce a partnership to enhance cell and gene therapy testing! By integrating novel lab-on-a-chip technology into the manufacturing process, we aim to improve precision, scalability, and efficiency. Curious about the possible impact on your products? Full Press Release: 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.” Would you like to learn how this partnership can benefit you? Connect with our Head of BD, Tristan Pritchard-Meaker! Read the article on our website: https://lnkd.in/eAjTFe6N #cellandgenetherapies #atmp #regerativemedicine #celltherapymanufacturing

How are iPSCs transforming regenerative medicine—and what do you need to know to stay ahead? Only 2 days left to sign up for our upcoming webinar with Catalina Gomez-Puerto, PhD! Are you: 👉 Looking for a practical overview of iPSC development and differentiation? 👉 Interested in case studies on Beta Cells, Dopaminergic Neurons, and RPE Cells? 👉 Want insights into the latest clinical applications of iPSC-derived therapies? Join us on February 20th at 4 PM (CET) for a focused discussion on these critical advancements. Sign up here: https://lnkd.in/ebPwHbzi Don’t miss this opportunity to deepen your understanding of iPSCs in cell therapy from a senior scientist with real-world experience. Do you have questions about NecstGen's solutions for iPSC developers? Connect with our Head of BD, Tristan Pritchard-Meaker.

Do you want to learn more about iPSC differentiation from a senior expert scientist? Next week is your chance on 20 February at 4 PM CET—don’t miss the chance to explore the potential of iPSC differentiation in regenerative medicine. Catalina Gomez-Puerto, PhD, Senior Scientist at NecstGen, will share insights into iPSC workflows, differentiation strategies, and real-world case studies. Why join and what will you learn? Swipe through the carousel for more details and register today! Do you have questions beforehand? Connect with our Head of BD, Tristan Pritchard-Meaker! #cgt #celltherapies #stemcells https://lnkd.in/ebPwHbzi

The Quality of a Cell & Gene Therapy product involves thorough development activities, in-process controls, process validation, and appropriate product specifications.   Any critical steps in the product manufacture process should be identified, experimentally evaluated, and minimised. Risks leading to failure of a product for clinical use or safety implications to the patient during manufacture can for example be caused by starting or raw materials.   Product quality equals patient safety.   At NecstGen, we know that quality cannot be tested into products, it should be built in by design. This can be achieved by implementing appropriate In-Process-Controls, Process Monitoring Tests, and Product Release Tests.   Our team is dedicated to ensure the highest quality for your Cell & Gene Therapy product. If you want to learn more about how this is being achieved at NecstGen, explore our webinar on “Product Quality for Cell Therapies” by Melissa Van Pel. https://lnkd.in/dm7Ufz6K   Reach out to NecstGen today to discover how we can accelerate your Cell & Gene Therapy development benefitting from expert knowledge, relevant experience, and access to state-of-the-art equipment and facilities: https://lnkd.in/ek99uMB4 #cellandgenetherapy #cgt #atmp #quality

Exciting progress in bone regeneration! NecstGen partnered with Dr. Debby Gawlitta from UMC Utrecht to explore GMP manufacturing options for her innovative MSC-derived spheroid therapy, bringing it one step closer to clinical application. Press Release: 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. For more information, visit necstgen.com or connect with Tristan Pritchard-Meaker #cgt #cellandgenetherapies #bonecells #atmps

This morning, we officially launched the IPCEI-P-SMaRT project, a collaboration between NecstGen, Leiden University Medical Center, NTrans Technologies BV, 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. Netherlands Enterprise Agency Ministerie van Volksgezondheid, Welzijn en Sport Gemeente Leiden Eelco de Koning Ton Rabelink Niels Geijsen Bart Jeroen Bierens Peter Heijkoop Sarah Opitz Ester Weijers 🔗 Read more about the project here: https://lnkd.in/eaURZiu3 We're looking forward to the next steps with our partners! #CGT #IPCEI #biotech #innovation #genetherapy #celltherapy