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 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.