NecstGen

𝐉𝐨𝐢𝐧 𝐎𝐮𝐫 𝐖𝐞𝐛𝐢𝐧𝐚𝐫: 𝐢𝐏𝐒𝐂 𝐃𝐢𝐟𝐟𝐞𝐫𝐞𝐧𝐭𝐢𝐚𝐭𝐢𝐨𝐧 𝐟𝐨𝐫 𝐂𝐮𝐫𝐚𝐭𝐢𝐯𝐞 𝐑𝐞𝐠𝐞𝐧𝐞𝐫𝐚𝐭𝐢𝐯𝐞 𝐂𝐞𝐥𝐥 𝐓𝐡𝐞𝐫𝐚𝐩𝐢𝐞𝐬 𝐨𝐟 𝐭𝐡𝐞 𝐅𝐮𝐭𝐮𝐫𝐞.   Learn how induced pluripotent stem cells (iPSCs) are being developed into potentially life-changing therapies. 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. When: February 20th, 4 PM (CET) Where: Online, registration required   Don’t miss this chance to explore the potential of iPSCs for regenerative cell therapies. Reserve your spot today: https://lnkd.in/eSR2rCDu   #ipsc #regenerativemedicine #celltherapy #webinar #futureofmedicine

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

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

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

𝐏𝐫𝐨𝐜𝐞𝐬𝐬 𝐝𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭 𝐟𝐨𝐫 𝐂𝐞𝐥𝐥 & 𝐆𝐞𝐧𝐞 𝐓𝐡𝐞𝐫𝐚𝐩𝐲 𝐦𝐚𝐧𝐮𝐟𝐚𝐜𝐭𝐮𝐫𝐢𝐧𝐠 𝐢𝐬 𝐞𝐬𝐬𝐞𝐧𝐭𝐢𝐚𝐥 𝐭𝐨 𝐚𝐜𝐡𝐢𝐞𝐯𝐞 𝐬𝐜𝐚𝐥𝐚𝐛𝐢𝐥𝐢𝐭𝐲, 𝐜𝐨𝐧𝐬𝐢𝐬𝐭𝐞𝐧𝐭 𝐩𝐫𝐨𝐝𝐮𝐜𝐭 𝐪𝐮𝐚𝐥𝐢𝐭𝐲, 𝐚𝐧𝐝 𝐜𝐨𝐬𝐭 𝐫𝐞𝐝𝐮𝐜𝐭𝐢𝐨𝐧.  Starting with the end in mind, it is helpful to identify and define your CGT product's Critical Quality Attributes and Critical Process Parameters, refining these as the development stages progress. At NecstGen, we approach each project using proven systems such as Quality by Design and Design of Experiments. Applying systematic approaches like QbD and DOE helps to ensure that sources of variability affecting the manufacturing process are identified, examined efficiently, explained, and managed by appropriate measures, all of which help to reduce the cost of goods. 𝐀𝐫𝐞 𝐲𝐨𝐮 𝐜𝐮𝐫𝐢𝐨𝐮𝐬 𝐚𝐛𝐨𝐮𝐭 𝐡𝐨𝐰 𝐐𝐛𝐃 𝐚𝐧𝐝 𝐃𝐎𝐄 𝐚𝐫𝐞 𝐛𝐞𝐢𝐧𝐠 𝐚𝐩𝐩𝐥𝐢𝐞𝐝? Watch NecstGen's webinar on "Transforming Your LV Process For CAR T - Shifting from traditional, ad hoc methodologies to a structured, data-based development approach to create a scalable, GMP-ready process": https://lnkd.in/emEK29tV Contact NecstGen today to explore how to accelerate your CGT process development, benefitting from expert knowledge, relevant experience, and access to state-of-the-art equipment and facilities: https://lnkd.in/ek99uMB4 #processdevelopment #CGT #ATMP #CART #viralvector

We want to invite you into one of our Viral Vector GMP downstream processing cleanrooms and showcase some of the equipment we use in our production workflow. NecstGen has a dedicated state-of-the-art facility to develop and manufacture Gene Therapies. With two full clean suites for Viral Vector manufacturing, we can support many organisations on their journey to the clinic. Every piece of equipment is essential in advancing Cell & Gene Therapies for patients. One key tool is the Cytiva AKTA readyflux, a tangential flow filtration system. Here, we can see our team are ensuring that the equipment is maintained, calibrated, and ready to go. As Cristina Muñoz Lopez, Viral Vector Specialist, shares: "The AKTA readyflux is a critical piece of equipment in our downstream processing. It is a tangential flow filtration system, and with it, we concentrate and formulate our final product to be ready to be used in Gene Therapies. Our team's drive is to ensure that we have the right equipment that is prepared and used well to maintain high standards and manufacture lifesaving therapies." At NecstGen, our laboratories and cleanrooms are where science meets purpose. The work behind the scenes reflects our commitment to delivering high-quality therapies and making a meaningful impact for caregivers and patients worldwide.

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

Automated Quality Control can transform Cell and Gene Therapy manufacturing, addressing its unique challenges. Analytics naturally ensure precision and consistency for critical parameters like cell viability and transduction efficiency. While automation reduces error, increases capacity, and accelerates testing for faster patient access. NecstGen leverages the Accellix automated cartridge-based flow cytometry platform to evaluate the transduction efficiency of a lentiviral vector. This approach is highlighted by using a lentiviral vector to create a model CAR T, which is a powerful tool for optimising vector design and transduction processes. Additionally, it showcases the potential of this methodology for broader assay development applications. Automated QC supports scalability to meet growing demand while maintaining rigorous quality standards. Providing detailed, traceable data streamlines regulatory compliance and minimises waste and rework. For further insights, read our recently published tech note on “CAR T lentiviral vector expression testing, identity and purity assessment throughout the cell therapy manufacturing process” from our collaboration with Accelix and bioMérieux. https://lnkd.in/eF4Ka3By By integrating automation, we can ensure the safety, efficacy, and reliability of life-changing therapies, paving the way for a healthier future.  #qualitycontrol #cellandgenetherapy #automation #ATMPs