NecstGen and Aarhus University Collaborate in Groundbreaking Initiative for GMP-Compliant Stem Cell Production

NecstGen and Aarhus University Collaborate in Groundbreaking Initiative for GMP-Compliant Stem Cell Production

Leiden November 16th, 2023 — NecstGen, Netherlands, a pioneering biotechnology center and non-profit CDMO specialising in Gene and Cell therapy, is proud to announce its groundbreaking collaboration with the Center for Gene and Cellular Therapy at Aarhus University Hospital (AUH), Denmark. This partnership aims to advance the production of mesenchymal stromal cells (MSCs) for experimental clinical use, ushering in a new era of advanced therapies and medical breakthroughs.

Mesenchymal stromal cells hold immense promise for regenerative medicine due to their remarkable ability to regenerate damaged tissue and regulate the immune system. However, their large-scale production while complying with strict Good Manufacturing Practice (GMP) standards has remained a challenge. NecstGen and AUH’s Center for Gene and Cellular Therapy are joining forces to address this challenge by introducing bioreactor-driven GMP-compliant MSC production processes.

Key Highlights of the Collaboration:

  • Advanced Bioreactor Use: Utilizing advanced bioreactors, the partnership will enhance MSC production, ensuring large-scale availability for clinical trials.
  • Strict GMP Adherence: Commitment to GMP standards guarantees the highest quality of MSCs, crucial for clinical use and future therapy commercialization.
  • Faster Clinical Trials: The initiative aims to fast-track the development of therapies for conditions like degenerative diseases and immune disorders through efficient MSC production.
  • Global Patient Impact: The collaboration is poised to make a substantial contribution to regenerative medicine, offering new treatment avenues for patients worldwide.
  • Scientific Excellence: Both entities are united in their pursuit of excellence, with a common goal to revolutionize healthcare through innovative cell therapies.

Dr. Melissa van Pel, Head of Cell Therapy at NecstGen, expressed her excitement about the collaboration, stating, “This partnership marks a significant milestone in the field of regenerative medicine. By combining our expertise with AUH’s Center for Gene and Cellular Therapy, we are poised to make substantial advancements in the production and clinical application of mesenchymal stromal cells.”

Dr. Bjarne K. Møller, Director of AUH’s Center for Gene and Cellular Therapy, added, “Our shared commitment to GMP compliance and rigorous scientific standards ensures that the MSCs produced through this collaboration will meet the highest quality and safety requirements. We are excited about the potential of this research to benefit patients in the near future.”

The collaboration between NecstGen, NL, and AUH’s Center for Gene and Cellular Therapy represents a leap forward in the field of regenerative medicine. Together, they aim to drive innovation, accelerate clinical development, and ultimately provide new hope for patients seeking advanced treatments for challenging medical conditions.

For media inquiries, please contact:

Tristan Pritchard-Meaker

Head of Business Development

NecstGen

Email: tristan@necstgen.com

Phone: +31 6253 44 672

About NecstGen:

The Netherlands Center for the Clinical Advancement of Stem Cell and Gene Therapies (NecstGen) comprises a state-of-the-art facility for development and GMP manufacturing of Cell and Gene Therapies. NecstGen additionally offers cleanroom rental, Quality Control services and a Qualified Person to allow organisations to maintain control of production while de-risking the capital investment required to do so.

Website: https://necstgen.com

About Aarhus University Hospital’s Center for Gene and Cellular Therapy:

The Center for Gene and Cellular Therapy at Aarhus University Hospital is dedicated to advancing the field of regenerative medicine through research, development, and clinical applications. Its mission is to bring cutting-edge therapies to patients with unmet medical needs.

LinkedIn: https://www.linkedin.com/posts/center-for-gene-and-cellular-therapy-aarhus-university-hospital_celltherapy-genetherapy-cgctauh-activity-7018188460528136192-zHhs/?trk=public_profile_like_view

NecstGen and ProteoNic Report Development of Improved Viral Vectors Through the Application of Premium 2G UNicTM Technology

NecstGen and ProteoNic Report Development of Improved Viral Vectors Through the Application of Premium 2G UNicTM Technology

NecstGen and ProteoNic Report Development of Improved Viral Vectors Through the Application of Premium 2G UNicTM Technology

Leiden, Netherlands, September 19, 2023 – Necstgen, a CDMO and centre of excellence for Cell and Gene Therapy, and ProteoNic, a leading provider of premium vector technology and services for efficient production of biologics, announce the successful development of improved lentiviral (LV) vectors, driving higher titers of functional viral particles based on the application of ProteoNic’s 2G UNic™ premium vector technology.

Both companies, located on the Leiden Bio Science Park, recognise the need to increase viral titres and optimise production processes. Cost-efficiency and manufacturing yields play a critical role in the feasibility of vector-based therapies. Through their combined efforts ProteoNic and NecstGen have achieved up to 5-fold higher functional LV titers, with significant potential impact on overall process efficiency.

Frank Pieper, CEO of ProteoNic commented “We are excited to see our collaboration with Necstgen achieving this important milestone. We will continue our efforts aimed at improving AAV and LV vectors, catering to both transient production systems and  stable viral producer cell lines”.

Paul Bilars CEO, NecstGen said “These significant results show the strength and importance of our local ecosystem, and highlight how collectively we can address the challenges of Cell and Gene Therapy development and their translation to solutions for patients and society”.

Through their combined efforts ProteoNic and NecstGen aim to improve and advance AAV and LV viral vector manufacturing technology and increase production capacity as well as payload expression in target tissues, to the ultimate benefit of patients in need of Cell and Gene Therapies.

The companies aim to make the improved technology broadly accessible. ProteoNic will offer licensing and co-development opportunities, while NecstGen plans to apply the technology in its CDMO business.

About ProteoNic

ProteoNic is a privately held company with offices in Leiden, the Netherlands and in the Boston area, USA. The company offers technology and services for the generation of cell lines and viral vectors with greatly improved production characteristics. The company commercializes its proprietary 2G UNic™ technology through licensing and partnership arrangements. For more information, see www.proteonic.nl.

 

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:

 

ProteoNic

Mark Posno, PhD

Vice President Business Development

T: +1 617 480 8016

E: posno@proteonic.nl

 

NecstGen

Tristan Pritchard-Meaker, PhD

Head of Business Development

E: tristan@necstgen.com

Cline Scientific announces Letter of Intent with NecstGen for the manufacture of its stem cell therapy for damaged cartilage

Cline Scientific announces Letter of Intent with NecstGen for the manufacture of its stem cell therapy for damaged cartilage

Cline Scientific announces Letter of Intent with NecstGen for the manufacture of its stem cell therapy for damaged cartilage

Mölndal, Sweden and Leiden, Netherlands, May 16, 2023 – Cline Scientific, a Swedish life science company developing a novel regenerative medicine, and NecstGen, a CDMO and centre of excellence for Cell and Gene Therapy, have signed a Letter of Intent to develop and manufacture clinical batches of Cline’s cell therapy for cartilage repair, StemCART.

Through this intended partnership, NecstGen will support the further development and manufacture of Cline’s cell therapy for damaged cartilage, StemCART. StemCART is an Advanced Therapy Medicinal Product (ATMP) that aims to revolutionize the treatment of cartilage damage for patients worldwide. The Swedish therapy developer envisions to out-license StemCART to a commercial partner following successful in-human trial results.

Hanne Evenbratt, CEO of Cline Scientific: “This LOI is an important first step in Cline’s preparation for the clinical phases of StemCART and a principal component of the manufacturing strategy. We are very excited to move forward with the team at NecstGen and anticipate a prosperous collaboration.”

Paul Bilars, CEO of NecstGen: “We are happy to support Cline Scientific throughout this critical phase in the development of its StemCART therapy. This potential joint action is very much a demonstration of our mission to support organizations developing therapies for patients”

About Cline Scientific
Cline Scientific develops advanced cancer diagnostics and regenerative medicine treatments. Cline’s unique patented surface nanotechnology provides solutions to critical challenges for cell-based products and processes in Life Science. Cline is driving two projects through to a clinical-stage, StemCART – a stem cell therapy for joint repair, and CellRACE- a cancer diagnostic to predict metastasis.

About NecstGen
NecstGen is a centre of excellence for Cell and Gene Therapy, located in a large 4000m2 purpose-built GMP facility on the biggest bio-cluster in the Netherlands, Leiden Bio Science Park. NecstGen provides critical contract development, manufacturing and rental services to all therapy developers who aim to deliver the next generation of treatments to patients. For more information visit www.necstgen.com.

Cline Scientific
Hanne Evenbratt, CEO. T: +46 0704887923 E: hanne.evenbratt@clinescientific.com

NecstGen
Tristan Pritchard-Meaker, Head of Business Development E: tristan@necstgen.com

bioMérieux partners with NecstGen

bioMérieux partners with NecstGen

bioMérieux partners with NecstGen

bioMérieux and NecstGen, collaborate to accelerate the development of Cell and Gene Therapies (CGT) through the provision of ‘state of the art’ and rapid quality and safety testing technologies that will allow safe and effective advanced therapeutics production.

Cell and Gene therapies are revolutionary treatments centered on using patient or donor cells, cultivated or modified outside of the body and re-introduced to the patient to induce the desired therapeutic effect. This complex field of therapies has opened the door to long-term cures for diseases such as cancers and orphan diseases and offers hope to patients and clinicians alike. However, the development and manufacture of safe and effective treatments, that can reach large numbers of patients, present many challenges. Scientist must ensure not only that their advanced therapy is effective it must also be manufactured in accordance with the requirements of the regulatory bodies and free off microbial contamination. They look to innovative microbiology companies, like bioMérieux, to provides solutions that will enable them to release safe medicines onto the market. 

Thanks to this new partnership, CGT researchers and manufacturers, hosted at NecstGen, will benefit from the solutions and services provided by bioMérieux to monitor and test their products and processes. bioMérieux rapid methods for Sterility testing, Mycoplasma detection and Endotoxin testing that form part of the partnership will allow them to realize good manufacturing practice (GMP) compliance and to overcome constraints specific to advanced therapies including product sacrifice for sampling, complexity of sample composition, and the need to reduce vein to vein time. Breaking down the testing bottlenecks, will help accelerate CGT development and improve access to these much-needed medicines for patients.

 Christie Downing-Kay, Head of Marketing for Northern Europe Cluster, bioMérieux comments, “CGT’s are the third horizon of medicine and have the potential to cure conditions, such as ‘orphan’ diseases, previously deemed incurable. bioMérieux is passionate about supporting the development of CGT’s and believe this collaboration with NecstGen will provide synergies that will benefit this promising field and help bring medicines to the patients that need them”.

NecstGen, is a centre of excellence for CGT, providing critical contract development, manufacturing and rental services to therapy developers to deliver a new generation of therapies to patients., NecstGen is located in a purpose-built GMP facility on the largest bio-cluster in the Netherlands, Leiden Bio Science Park.

Paul Bilars, CEO at NecstGen added “We are very happy to engage in this collaboration and share knowledge in CGT manufacturing and Quality Control. Ultimately, this partnership will help us to offer our clients the best support and access to state-of-the-art systems to advance the development of their next generation therapies.

This collaboration with NecstGen is the culmination of developing solutions adapted to the constraints of this market, as well as educational content to support the key players in the production of CGT as underlined by Michaël Reynier (Sr Vice President for the Pharma Quality Control Business, bioMérieux): “We are very pleased to join forces with NecstGen to offer CGT developers a strong portfolio of value-added Quality Control solutions within a state-of-the-art Cell Therapy development and GMP manufacturing environment to speed up path to the market and release of life saving advanced therapies.”

Overcoming complex manufacturing challenges and ensuring the quality, safety, and efficacy of cell and gene therapies administered to patients is critical. That’s why bioMérieux delivers a proven portfolio of value-added solutions to add rapid and easy-to-use technologies to operations and bring overall efficiencies to the manufacturing process through both simplified workflows and accurate, actionable results to ensure patient safety.

NecstGen Announces Major Milestone – GMP Manufacturing License

NecstGen Announces Major Milestone – GMP Manufacturing License

NecstGen Announces Major Milestone – GMP Manufacturing License

1 December 2022, Leiden, today the NecstGen team is happy to announce that is has received its GMP Manufacturing License. Farmatec, part of the Dutch Ministry of Health, Welfare and Sport has granted NecstGen its license for the GMP manufacturing of Advanced Therapy Medicinal Products.

Throughout the last year, NecstGen has finalised the construction of its brand-new 4,000 m2 GMP facility on the Leiden Bio Science Park. In November, a GMP inspection was carried out by the Dutch Health and Youth Care Inspectorate (IGJ). Following the positive outcome of this inspection, NecstGen has received the license for the GMP manufacturing of ATMPs from Farmatec/CIBG, the executive body of the Ministry of Health, Welfare and Sport (VWS).

Paul Bilars, CEO said “This is a culmination, a stamp of approval, on the work of our dedicated team. It is a symbol of the high standards we aim to maintain daily, and the trust placed within us as an organisation. With the determination of our expert team and many others it has been possible to meet the standards for achieving our Manufacturing License.”

The license allows NecstGen to manufacture and release Cell and Gene Therapies for patients. As a Centre of Excellence for Cell and Gene Therapies, NecstGen aims to accelerate the development and manufacturing of this next generation of promising therapies by providing critical services. Through its GMP facility containing 13 cleanrooms, NecstGen can support academic and industrial therapy developers, offering flexibility in both scale and modality.

Find out more about NecstGen and its facility in the video below:

About NecstGen

NecstGen is a new centre of excellence for Cell and Gene Therapy development and manufacturing, located in a purpose-built GMP facility at the Leiden Bio Science Park. NecstGen has a focused expert team and bespoke facility to offer the support and capacity needed to deliver Cell and Gene Therapies to patients. Our +4,000 m2 facility encompasses development labs and GMP suites to accommodate the manufacturing of therapies in different operational modes. NecstGen’s dedicated Viral Vector suites offer segregated inoculum, upstream and downstream processing capabilities to maximize batch throughput. The multi-use Grade B and C cleanrooms are available for manufacturing therapies, including Cell Therapies, Ex vivo Gene Therapies, and Gene Therapies. NecstGen offers complete contract manufacturing for Cell Therapy and Viral Vector and cleanroom rental for any mammalian-based therapy type. 

Pan Cancer T and NecstGen Collaborate to Accelerate Novel TCR-T Therapies into Clinical Development

Pan Cancer T and NecstGen Collaborate to Accelerate Novel TCR-T Therapies into Clinical Development

Pan Cancer T and NecstGen Collaborate to Accelerate Novel TCR-T Therapies into Clinical Development

Rotterdam and Leiden, the Netherlands, November 23, 2022 – Pan Cancer T B.V., a biotech spin-off from Erasmus MC dedicated to the discovery and development of novel second generation TCR-T therapies against solid tumors, and NecstGen B.V., The Netherlands Center for the Clinical Advancement of Stem Cells and Gene Therapy, today announced a partnership to advance Pan Cancer T’s innovative therapies into the clinic. Under the agreement, NecstGen will provide process and analytical development capabilities.

 “We are delighted about this important partnership with NecstGen, which enables us to set up top-tier GMP manufacturing processes for our novel TCR-T therapies,” said Katrien Reynders-Frederix, CEO of Pan Cancer T. “This is a key prerequisite for reaching our next major milestone, i.e., progressing our first therapeutic candidate into clinical development.”

Both Pan Cancer T and NecstGen recognize the need to implement from the start appropriate production processes required for cutting-edge GMP manufacturing to ensure safe and effective cell and gene therapies. NecstGen’s Cell Therapy Development team, led by Melissa van Pel is excited to be working with Pan Cancer T on this project.

Paul Bilars, CEO of NecstGen, said: “I very much see this project as a demonstration of NecstGen’s mission to enable therapy developers to reach their goals. By doing so, we at NecstGen play our part in the successful delivery of cell and gene therapies. For NecstGen to be chosen by Pan Cancer T as a partner on their journey is indeed an honor.”

The NecstGen team has built a state-of-the-art development and manufacturing facility and will collaboratively work with Pan Cancer T’s experts. Each party will bring its unique knowledge and ability to this strategically important partnership.

About Pan Cancer T

Pan Cancer T was founded in late 2020 and as a spin-off from Erasmus MC (Rotterdam, the Netherlands) to advance novel, next generation TCR T-cell therapies for hard-to-treat solid tumors. The Company’s approach includes three differentiating elements. Firstly, our discovery platform uncovered 30 novel tumor targets that are selectively and robustly expressed across 10 major solid tumors. Secondly, we develop engineering technology that enhances the durability of the T cells, making them resistant to the local immune suppression of the tumor. 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 development and manufacturing, located in a purpose-built GMP facility at the Leiden Bio Science Park. NecstGen has a focused expert team and bespoke facility to offer the support and capacity needed to deliver Cell and Gene Therapies to patients. Our +4,000 m2 facility encompasses development labs and GMP suites to accommodate the manufacturing of therapies in different operational modes. NecstGen’s dedicated Viral Vector suites offer segregated inoculum, upstream and downstream processing capabilities to maximize batch throughput. The multi-use Grade B and C cleanrooms are available for manufacturing therapies, including Cell Therapies, Ex vivo Gene Therapies, and Gene Therapies. NecstGen offers complete contract manufacturing for Cell Therapy and Viral Vector and cleanroom rental for any mammalian-based therapy type. 

Cell Therapy Manufacturing & Development

Viral Vector Manufacturing & Development

Cleanroom Rental