Bilthoven (NL), November 2020
Eurostars project Bioscale focuses on the SCINUS expansion system
Developing an efficient cell therapy production platform
Cell therapy (CT), using cultured human cells, is a treatment option that holds great promise for curing a vast number of difficult-to-treat diseases, such as diabetes, Alzheimer’s and ALS, and also for skin reconstruction or promoting recovery from an infarct. While cell therapies are currently moving into clinical practice, the production of cells on a commercial scale poses a major economic and industrial challenge. The new Eurostars project Bioscale will focus on the SCINUS expansion system, for cost-efficient cell culture, to achieve standardised CT production, ultimately leading to improved quality consistency in CT development and a reduced cost of CT commercialisation.
Worldwide, cell therapy (CT) is an area of intense research, with over 600 ongoing trials and 21 approved CTs and cell-based products already on the market in the EU and US. Although the therapeutic potential of CTs is widely acknowledged, the successful translation of CTs from the lab to the hospital ward is limited. Cell therapies are ready to move towards clinical practice, but the production of cells on a commercial scale still poses a major economic and industrial challenge. Typically, cell therapies originate in the research labs of academic institutions, where cells are cultured in small flasks inside controlled incubators. However, this culture approach is very labour intensive, and the many open process steps require strict (expensive) cleanroom procedures once the translation to actual clinical production has to be made.
To address the need for efficient production platforms, as identified by the medical field, the Eurostars project Bioscale (projectnumber E!114513) has been defined and allocated a budget of 2.8M Euros. The Eurostars programme supports innovative international projects led by R&D-performing SMEs and is co-funded by the Eurostars partner states and the EU (through Horizon 2020). The Bioscale project focuses on the stem cell expansion technology, for cost-efficient cell culture. The project will expand the capabilities of the SCINUS bioreactor to provide a truly universal platform for cost-effective CT production. The ability to cultivate all cell types (adherent as well as suspension) and further process automation are main deliverables for this project.
The Bioscale project, which will run from 2020 to 2023, involves cross-border collaboration with partners from the Netherlands, Belgium, Switzerland and Sweden. Interactive batch records and smart algorithms will be developed by MyCellHub (Belgium) to reduce operator involvement and enable regulatory-compliant scalable cell production and in-depth bio-analytics. A new disposable culture container to grow non-adherent cells in suspension (a major CT culture method) will be developed by Scinus Cell Expansion, together with novel integrated sensor technology. Membrane filter technology allowing suspension culture will be developed by SEFAR (Switzerland) and incorporated into the suspension culture container. NextCell Pharma (Sweden) uses a proprietary cell-selection algorithm based on functional and potency assays to achieve high-quality production of their MSC-based CT ProTrans, which is initially focused on type-1 diabetes. In this project, NextCell Pharma will integrate assays into the SCINUS workflow to optimise production of ProTrans and compare it to 2D culture. Scinus Cell Expansion will validate SCINUS suspension culture capability by producing non-adherent iPSCs (induced pluripotent stem cells).
Improved quality, reduced cost
“SCINUS will standardise CT production”, explains Scinus CEO Michiel Jannink. “This will lead to improved quality consistency in CT development and a reduced cost of CT commercialisation. Ultimately, we aim to contribute to improving treatment options for millions of patients and reducing healthcare costs with the aid of cell therapy.” Mathias Svahn, CEO of NextCell Pharma, adds, “the Bioscale project will provide the next step in production optimisation and upscaling of ProTrans, our promising stem-cell-based drug candidate for the treatment of autoimmune diseases, initially focusing on type-1 diabetes.”
Gemini Bio to Distribute Scinus Products in the United States
18 August 2020
Gemini Bio adds Scinus Bioreactor to its portfolio
WEST SACRAMENTO, CA and BILTHOVEN, The Netherlands, August 18, 2020 – Gemini Bioproducts, LLC (“Gemini Bio”), a leading supplier of cell culture solutions and a portfolio company of BelHealth Investment Partners, LLC (“BelHealth”), a New York-based healthcare private equity firm, today announced a distribution agreement with Scinus Cell Expansion Netherlands BV (“Scinus”). Customers will now be able to purchase the Scinus Cell expansion bioreactor system directly from Gemini Bio in the US.
This cell expansion bioreactor system enables clinical scale stem cell cultivation in a controlled environment, which is a cost-effective alternative to traditional 2D cell growth in tissue culture flasks or cell stacks. The system contains a single use bioreactor bag that can be used to cultivate cells to clinically relevant numbers which can enable cutting edge cell therapies to be delivered to patients.
Brendan Lucey, Gemini Bio VP of Business Development, stated, “I am extremely excited to add Scinus’ innovative Bioreactor to the Gemini portfolio. In addition to supplying reagents and instruments for cell Quality Control, we now have a next generation bioreactor for cell therapy applications. This addition continues our focus on supporting breakthroughs in the cell therapy field with innovative bioprocessing solutions that allow for an easy transition from R&D to clinical manufacturing.”
Michiel Jannink, CEO of Scinus Cell Expansion, added, “We are really looking forward to working with Gemini Bio. Our products are very complementary and we both have the same mission: to bring the field of cell therapy further!”
Learn more at www.gembio.com.
About Gemini Bio
Founded in 1985, Gemini Bio is a leading provider of cell culture solutions to the scientific community across cell and gene therapy, biotechnology, and academic research. Gemini Bio also offers contract manufacturing and regulatory consulting services. Gemini Bio’s singular mission is to enhance human life by delivering comprehensive cell culture solutions that enable discovery, development, and production of transformational therapies. Our national sales force and international distribution network serves cell culture science worldwide. The Company is based in West Sacramento, California.
Founded in 2004 (as part of Xpand biotechnology), Scinus Cell Expansion is a Dutch company which develops and distributes bioreactor technology for stem cell cultivation. Scinus’ mission is to make cell therapies accessible for a global patient population by means of developing an innovative bioreactor platform technology for the cell therapy industry. In addition to the development and marketing of bioreactor technology Scinus also offers process optimization and translation consulting services
Gemini Bio: Brendan Lucey, +1-302-287-2385
Scinus: Michiel Jannink, e-mail: email@example.com
BelHealth Investment Partners: Inder Tallur, (347) 308-7018
Technology developer and manufacturer Demcon acquired a share in Scinus Cell Expansion
18 June 2019
At the end of last year, technology developer and manufacturer Demcon acquired a share in Scinus Cell Expansion, which develops equipment for stem cell therapy. Stem cell therapy has the potential to cure diseases related to the nervous system, diabetes, heart and vascular diseases, kidney diseases, Alzheimer and recovery following an infarction or to allow skin reconstruction. In order for stem cell therapy to be available to larger numbers of patients, it must be possible to culture the required stem cells simply in clinically relevant numbers. Scinus has developed promising technology for this, which is more reproducible, cheaper and less labour-intensive than the current technology. Demcon is now helping Scinus to enter the market. For this purpose, Michiel Jannink, Managing Director of Demcon medical systems, is also acting as CEO of Scinus. “Our main contribution is our experience in the marketing of medical technology and in this way we want to contribute to making stem cell therapy a mainstream treatment.”
The medical division is one of the largest branches in the rapidly expanding Demcon Group. This division focuses on – for example – in-vitro diagnostics, medical robotics and hospital equipment. General Manager Dennis Schipper explains that the company had a long-held desire to expand into tissue technology: “As a technology developer, we want to accept social corporate responsibility in our own way. One of the ways in which we achieve this is by contributing to developments in healthcare. Medical technology is currently aimed primarily at repairing the human body. However, a gradual shift is taking place towards stimulating the body to heal itself, for example with the aid of tissue culture techniques. We can develop equipment for this.”
A unique opportunity presented itself when the start-up Scinus Cell Expansion was looking for a strategic partner last autumn, to facilitate further growth and to enter the market. Scinus in Bilthoven (five employees) develops and supplies bioreactor technology for the culture of stem cells. The mission of Scinus is to make stem cell therapy globally accessible for a large group of patients. Stem cell therapy presents the promise of a cure for diseases related to the nervous system, diabetes, heart and vascular diseases, kidney diseases and Alzheimer. In addition, stem cells could be used for recovery after – for example – a cardiac or cerebral infarction and for the reconstruction of the skin following severe burn wounds, or in combination with an organ transplant.
Culturing stem cells
Stem cell therapy requires large numbers of stem cells, up to half a billion. It starts with stem cells that are obtained from – for example – the bone marrow or fatty tissue of the patient. This harvesting procedure may yield about a million cells, so they need to be multiplied. Until now, culturing has been performed in a 2D environment, in a medium on a nutritional substrate in culture flasks. This is a labour-intensive procedure consisting of several cycles in which cells are harvested and then seeded on new cultures to produce the required number of cells. This requires a large-scale deployment of specialised lab technicians and a complex, expensive cleanroom infrastructure to reduce the risk of contamination of the culture. “The entire field is convinced that we need to move towards bioreactors, thus requiring fewer man hours and resulting in less wastage of expensive medium.” This according to Michiel Jannink, Managing Director of Demcon medical systems, who has been acting as CEO of Scinus since the autumn of last year.
Innovative bioreactor technology
Scinus has developed an innovative alternative for the labour-intensive 2D culture method. This involves the controlled 3D culture of stem cells in a closed system. A flexible bioreactor bag is first mainly rolled up and can then slowly unfurl to expand along with the cell culture until the required number of cells has been produced in a continuous culture process. Scinus worked together with Applikon Biotechnology in Delft, they supplied the control technology for this system. Sensors monitor the oxygen concentration and the pH, and oxygen or CO2 can be added if necessary, explains Jannink. “This control loop ensures an optimal culture environment at all times and the biosensors allow us to monitor the growth of the cells. The medium and the micro-carriers on which the cells grow are added gradually. This method allows up to two billion cells to be cultured. Lab technicians perform the role of operator during this culture process, by closely monitoring the process. They can also develop new culture protocols. After all, this is still a delicate process that has to comply with all GMP requirements (Good Manufacturing Practices, a quality assurance system for the pharmaceutical industry, ed.).”
This new method of culturing cells is much simpler and produces results more quickly. Scinus worked closely with the Leiden University Medical Centre during the development of this method. Jannink: “The system is now ready for use in clinical practice, where additional research with several academic medical centers worldwide will take place. We have held initial discussions with key opinion leaders about installing a system in their clinic. They are positive about the functionality, particularly the good control over the cell growth process.”
Since taking a share in the company last autumn, Demcon has been a strategic partner for Scinus, providing the financial and technological support the company needs to ultimately enter the market. Jannink: “My role is to provide the expertise of Demcon in this field and to help Scinus to grow further. This includes setting up clinical trials, maintaining relationships with key individuals in the field and building a distribution network for the global sales of these systems. Our ultimate goal is to make stem cell culture easier and more affordable, thereby contributing to making stem cell therapy a mainstream option.”
Demcon (650 employees) develops, produces and supplies technology and innovative products and systems that offer solutions for the technical and societal challenges of clients and end users across the world. The focus areas are high-tech systems, medical systems, industrial systems & vision, optomechatronic systems and robotic systems. Demcon has branches in Enschede, Best, Delft, Groningen, Oldenzaal and Münster (Germany).