Dutch-Danish collaboration between Aarhus University Hospital and Scinus Cell Expansion

PRESS RELEASE

Bilthoven (NL)/Aarhus (DK), July 2023

Dutch-Danish collaboration on cell therapy

Cell therapy, which uses cultured human cells, is a promising treatment option for a wide range of diseases. However, for cell therapies to be used in clinical practice, they must be produced in a controlled and cost-effective manner. The Dutch company Scinus Cell Expansion has an innovative cell expansion bioreactor technology, which allows for the costefficient and controlled cultivation of stem cells. Scinus collaborates with leading academic hospitals, such as the Danish Aarhus University Hospital, which has established the Center for Gene and Cellular Therapy. There, a SCINUS bioreactor will be incorporated into the stem cell therapy GMP workflow for clinical studies and patient treatment.

Cell therapy (CT) is a rapidly developing field with the potential to revolutionize the treatment of many diseases. However, there are still significant challenges to overcome before CT can be widely adopted in clinical practice. One of the biggest challenges is the production of cells on a cost-efficient and controlled scale. Currently, CTs are often still produced in flasks. This approach is very labor-intensive and inefficient. One promising alternative is to use bioreactors. Bioreactors are automated systems that can culture cells in a controlled environment. This allows for the production of cells in large quantities while maintaining high quality standards.

Innovative bioreactor technology
Scinus Cell Expansion, a Dutch company, has developed automated bioreactor technology that can be used to cultivate (stem) cells in a controlled environment. The system is designed to be more efficient and reproducible than traditional manual methods, and it can help to reduce the cost of cell therapy production. The heart of the SCINUS expansion system is a flexible bioreactor bag with integrated sensors (pH and oxygen) that can be rolled up and unrolled to control the available volume for cell growth. This results in an optimally controlled culture environment for the cells.

Center for Gene and Cellular Therapy, Aarhus University Hospital
The process in a Scinus bioreactor must meet all GMP (Good Manufacturing Practices) requirements for Advanced Therapy Medical Products before it can be used in clinical applications. Scinus is collaborating with Aarhus University Hospital, a leading academic hospital in Denmark. Aarhus University Hospital has opened its Center for Gene and Cellular Therapy in 2022, with funding from the Danish Innovation Fund. The center has a complete GMP workflow for clinical studies using adult stem cells, including regulatory procedures. Bjarne K. Møller, head consultant and associate professor at the center, says: “We have a cell therapy workflow based on open-flask culture that has already been approved by the Danish Medicines Agency. Our aim is to incorporate the SCINUS bioreactor technology for the production of clinical grade cells in this workflow and obtain approval for that as well.”

Large-scale cell production
The Aarhus center aims to expand stem cells on a large scale, which is a cost-effective way to introduce stem cell therapy into clinical practice. Dr. Møller explains that using multiple flasks for cell expansion is a highly labor-intensive procedure. There are already large-scale bioreactors available on the market, but the Aarhus center has chosen the SCINUS system because of its advantages. Dr. Møller explains that the SCINUS bioreactor has a high output, integrated sensors to monitor the cell culture environment and a continuous perfusion loop. In addition, the SCINUS bioreactor is a closed system, which means that the center does not have to operate it under stringent class A cleanroom conditions. This makes their work much more comfortable and efficient. The system is also transparent, which allows the center to observe the cells during expansion. This, in combination with taking samples during the process for quality control, helps them to determine the right moment for harvesting the cells.

Treatment of patients
Scinus and the Aarhus Center officially started their collaboration on March 1st 2022. They have installed the bioreactor, and the staff has started validating the methods. Aarhus researchers aim to set up pre-clinical studies using the new bioreactor. If these studies are successful, they will apply for approval by the Danish health authorities to accept therapy using cells produced with the SCINUS bioreactor as a standard treatment for patients in their hospital and eventually in other Danish hospitals. That’s why they consider the SCINUS system more as a production facility than a research facility. Jannink said, “That will be the ultimate win of this collaboration, enabling an effective and
affordable treatment of patients.”

About Scinus Cell Expansion
Scinus Cell Expansion Netherlands BV in Bilthoven, the Netherlands, develops innovative, reliable and cost-effective solutions for automating the cultivation of cells. The mission of Scinus is to make cell therapy accessible worldwide for a wide patient population.

About Center for Gene and Cellular Therapy at Aarhus University Hospital
The Center for Gene and Cellular Therapy (CGCT) at Aarhus University Hospital in Aarhus, Denmark, is a leading center for research and development in cell therapy. The CGCT performs pre-clinical studies in various types of cell therapy, including hematopoietic stem cell transplantation, mesenchymal stem cell therapy, and gene therapy. The center is also in charge of the production of clinical grade stem cells in experimental clinical protocols of regenerative and immunomodulatory medicine. The CGCT was established in 2022 with the goal of developing new cell therapy treatments for a variety of diseases. The center is staffed by a team of experienced technicians, scientists and clinicians who are committed to advancing the field of cell therapy. The CGCT has a state-of-the-art facility that is equipped with the latest technology for cell culture, GMP manufacturing, and support for clinical trials. The center already has a strong track record of collaboration with other academic institutions and industry partners. The CGCT is at the forefront of research in clinical cell therapy, and its work is helping to pave the way for new and innovative treatments for a variety of diseases