E!114513, Bioscale, NextCell Pharma
| Reference number | |
| Coordinator | NextCell Pharma AB |
| Funding from Vinnova | SEK 4 932 388 |
| Project duration | September 2020 - August 2023 |
| Status | Completed |
| Venture | Eurostars |
Important results from the project
The aim of this project was to deliver a prototype bioreactor (SCINUS) for scalable manufacturing of cell therapy (CT) products. The objective was that the SCINUS would standardize CT production, leading to improved quality consistency and reduced costs of CT commercialization, thereby improving treatment options and reducing healthcare costs. The clinical umbilical cord mesenchymal stromal cell product, ProTrans, used in clinical trials for the treatment of type 1 diabetes served as an example CT to establish product comparability between 2D and 3D culture systems.
Expected long term effects
SCINUS produced CT can be comparable in terms of quality, identity and functionality to 2D systems. Production of cells was reproducible and robust, achieving the objective for consistency. Comparisons highlighted the impact of manufacturing in 3D, minimising costs, through reducing labour requirements and specialist training knowledge of the operators and facility requirements due to the closed working environment of SCINUS. Working in this manner will increase sustainability impact, reducing the need for single use plastics.
Approach and implementation
Challenges remain in moving from production of CTs in 2D to 3D systems, including changes in quality control and regulatory requirements. With the data achieved, and comparability demonstrated, the consortium are continuing to work to implement this transition. Although still in the development phase, the potential of manufacturing in this manner addresses the scalability issues of the drug developer and manufacturing, while catering for a more environmentally friendly and economically viable production process.