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.”