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Process development for the production of GMP-grade therapeutic mesenchymal stem cells from amniotic fluid

Reference number
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.

The project description has been provided by the project members themselves and the text has not been looked at by our editors.

Last updated 8 January 2019

Reference number 2018-01045

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