• A grant from IPCEI Med4Health will facilitate the development of advanced technologies to improve cell and gene therapy production.

• The consortium will focus on novel technologies and production processes to overcome current bottlenecks in cell and gene therapy manufacturing, enabling cost-effective production and facilitating clinical trials for conditions like Duchenne Muscular Dystrophy and Diamond Blackfan Anemia.

Leiden, the Netherlands, August 28, 2024 – In a major advancement toward bringing cell and gene therapies more rapidly to patients, NecstGen, together with partners NTrans Technologies, Leiden University Medical Center (LUMC), and Divvly, has been awarded a €10 million grant from the European Union’s Important Project of Common European Interest (IPCEI) Med4Cure program. This project aims to transform the treatment landscape for serious medical conditions like Duchenne Muscular Dystrophy and Diamond Blackfan Anemia by pioneering cost-effective production methods, making these treatments more accessible.

Addressing Major Industry Challenges

Cell and gene therapies offer the potential to treat, prevent, and cure devastating diseases by targeting the underlying genetic causes. Yet, their development is often hindered by high costs and complex manufacturing processes, largely due to limited access to advanced production methods. This restricts therapy developers and manufacturers from scaling up production effectively. This project aims to break down these barriers, enhancing the scalability and affordability of therapies and ensuring that they reach patients quicker.

Collaborative Efforts and Impact

NecstGen, a non-profit contract development and manufacturing organization (CDMO), will lead the project, leveraging its comprehensive approach to implementing a complete value chain, from concept to patient. It will focus on innovative cell line and production process technologies to reduce overall production costs. NTrans Technologies will improve treatment effectivenes s through its proprietary gene-editing platform, while Divvly will enhance industry compliance for Good Manufacturing Practices (GMP) with its advanced software solutions. The LUMC, a renowned Dutch medical university, will lead (pre-)clinical trials, offering crucial insights and support, directly impacting therapy development for Duchenne Muscular Dystrophy and Diamond Blackfan Anemia.

“By uniting our strengths and challenging current paradigms in cell and gene therapy manufacturing, we can accelerate the availability of these life-saving therapies,” said Paul Bilars, Chief Executive Officer, NecstGen. “At NecstGen, we are dedicated to transforming these technologies to support therapy developers and ultimately, deliver life-changing treatments to patients, both in Europe and globally.”

About IPCEI
The Important Project of Common European Interest (IPCEI) is an initiative by the European Union designed to support large-scale, cross-border projects that are highly innovative and strategically important for Europe. With 14 highly innovative projects, the IPCEI Med4Cure program aims to enhance drug discovery and pharmaceutical production processes, addressing major health challenges and fostering innovation and collaboration across Europe.

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.

For more information about our project, please visit our website or contact us directly. If you are a therapy developer or industry professional interested in partnering with us or learning about our innovative solutions, please reach out to:
https://necstgen.com/contact-us/

For media inquiries, please contact:
bd@necstgen.com

This project has received funding from Rijksdienst voor Ondernemend Nederland (Netherlands Enterprise Agency).

NecstGen Services

We offer process development solutions, contract preclinical/ GMP manufacturing and cleanroom rental for Cell and Gene Therapies to clinicians, academic, small, medium, and large commercial organisations worldwide.

Viral Vector Manufacturing & Development

Cleanroom Rental

Cell Therapy Manufacturing & Development

About Us

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 to focus on patient solutions.

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