Process development for the production of GMP-grade therapeutic mesenchymal stem cells from amniotic fluid
| Reference number | |
| Coordinator | LONGBOAT AMNIOTICS AB |
| Funding from Vinnova | SEK 300 000 |
| Project duration | June 2018 - March 2019 |
| Status | Completed |
| Venture | Innovative Startups |
Purpose and goal
The projects purpose was process development for the production of GMP-grade therapeutic mesenchymal stem cells from amniotic fluid. The goal was to obtain a process possible to scale up for validation and production of TAF-MSCs in a GMP facility. In particular, cell culture conditions such as surfaces, media, and oxygen levels as well as cryogenic storage solutions for cells were examined.
Expected results and effects
After the successful completion of this project, Longboat is focusing on GMP grade MSC production. This project has already started with the building of a GMP classed production facility at Medicon Village, Lund. The facility is projected to be finished in June and fully operational by the end of the year.
Planned approach and implementation
To increase TAF-MSC yield, the optimal GMP compatible plating and cultivation surfaces were determined. Growth potential of TAF-MSC in ten commercially available GMP compliant media was tested and the best medias determined. Testing of TAF-MSC propagation under hypoxia conditions indicated that hypoxia could be used in the process. GMP-compliant freezing media compatible with TAF-MSCs were tested. A GMP compliant media from a commercial source was found to be superior to the conventional freeze mixture regarding cell recovery and viability after storage and subsequent thawing.