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

Cline Scientific
Hanne Evenbratt, CEO. T: +46 0704887923 E:

Tristan Pritchard-Meaker, Head of Business Development E:

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. 

Webinar: How to develop your Cell Therapy manufacturing process

Webinar: How to develop your Cell Therapy manufacturing process

Webinar: How to develop your Cell Therapy manufacturing process

Webinar: How to develop your Cell Therapy manufacturing process

How do you translate your Cell Therapy processes to GMP? What are the challenges of bringing an iPSC-based therapy to the patient? How to set up a CAR-T manufacturing process?

On Wednesday 14 December we will explore the challenges one may face in establishing a Cell Therapy process for application in clinical trials. During this webinar, Melissa van Pel, head of Cell Therapy at NecstGen, will discuss two exemplary cell therapy types:

1) Induced pluripotent stem cell therapy (iPSC), a relatively new type of Cell Therapy that is regarded as one of the most promising solutions in regenerative medicine.

2) Chimeric antigen receptor T-cell therapy (CAR-T), a well established type of Cell Therapy that has faced commercial and clinical success, as well as logistical challenges as it matures.

We look forward to welcoming you to this online seminar.


  • 16:00hr – Welcome – Tristan Pritchard-Meaker (Head of Business Development, NecstGen)
  • 16:05hr – How to set up your Cell Therapy process – Melissa van Pel (Head of Cell Therapy, NecstGen)
  • 16:40hr – Interactive Q&A session

Date and time

  • Wednesday, December 14, 2022, 4:00 PM – 4:45 PM CET


  • Online 
Press Release Horizon Europe Grant BioProS

Press Release Horizon Europe Grant BioProS

Press Release Horizon Europe Grant BioProS

NecstGen Joins Major New Collaboration Project to Create Biointelligent Sensor for Improved Biomanufacturing

As part of the Horizon Europe framework, NecstGen has joined an international consortium, that will work to develop Biointelligent Sensors for real time in production measurement and control of therapeutics including Cell and Gene Therapies. The biohybrid sensor technology will help optimise biomanufacturing and so deliver exciting new technology. It is funded with over 6 million euros as part of the European HORIZON programme, started on 1 July 2022, and will run for 48 months.

NecstGen joins as an organisation with expertise in the development and manufacturing of Cell and Gene Therapies. A fundamental and key part of delivering the safe and efficacious therapeutics of tomorrow is to understand how the systems and processes to manufacture them are performing. In the project NecstGen will work to develop an example manufacturing system on which new technologies can be developed and tested.

The convergence of technical, informational, and biological systems are the basis of biointelligence. This new paradigm opens up a huge innovation space globally. Because Europe is at the forefront of manufacturing excellence, BioProS will make a significant contribution to sustainable and resilient manufacturing processes in the EU. Digital and bio-based process chains have the potential to revolutionise many industries and ensure their competitiveness.

The goal of BioProS is to optimise the production processes for therapeutic viruses through better quality control. A biohybrid sensor technology monitors cell-based virus infection cycles in real time. For this purpose, optical sensor technology is combined with cell-based measurement principles. Within BioProS, a platform technology is being developed that can be adapted to several specific substances and virus types. This allows applying it in different industries and production environments. Since such a platform technology is complex, numerous European partners from different disciplines such as biology, engineering and mechanical engineering or computer science are involved.

Seven partners from five countries are represented in the BioProS consortium: BICO Group AB, Sweden, NecstGen, the Netherlands, Fraunhofer (IPA and IGB), Germany, Eberhard Karls Universität Tübingen, Germany, EurA AG, Germany, ElveSys, France and Politenico di Milano, Italy. The consortium gathers all the necessary expertise under its roof and forms the basis for international partnerships. In close cooperation with other European initiatives and with the support of an industrial advisory board, the project partners want to realise the vision of biointelligent manufacturing and demonstrate the applicability of disruptive technologies in an industrial setting. This will foster research for biointelligent methods and global applications while guaranteeing technological sovereignty for Europe in the long term.

This project has received funding from the European Union’s Horizon Europe research and innovation programme (HORIZON-CL4-2021-DIGITAL-EMERGING-01-27: Development of technologies/devices for bio-intelligent manufacturing (RIA)) under grant agreement No 101070120.

Cell Therapy Manufacturing & Development

Viral Vector Manufacturing & Development

Cleanroom Rental