Eurostars project, LAMMIC, E!8972, BioLamina AB

Purpose and goal

The project aimed at enabling a standardized and scalable stem cell culture for cell therapy, drug development and toxicology studies. We will develop and commercialize LN-521 coated hydrogel microcarriers and protocols for the expansion of human pluripotent stem cells (hPSC) in bioreactors. The main goals were to develop: 1. A method to scale up the production of recombinant LN-521 2. A hydrogel microcarrier coated with LN-521 adapted to support hPSC growth 3. An optimized protocol to grow hPSCs in bioreactors

Expected results and effects

The project partners were to 1) scale up production of LN-521, 2) develop GMP LN-521, 3) develop a new hydrogel microcarrier coated with LN-521 for scalable hPSC culture in bioreactors. Both GMP LN521 and the LN-521-coated hydrogel beads were going to be commercialized. We have managed to 1) scale up production, 2) develop GMP cell line expressing LN-521, 3) validate GMP LN-521 function, 4) schedule a GMP pilot run at GMP certified CMO, 5) identify a hydrogel covalently linked with low concentrations of LN-521 capable of supporting stem cell expansion.

Planned approach and implementation

The project is divided into 4 WPs: 1. Scale up LN-521 production Methods: A suspension-based cell line called CAP has been used Analysis: The CAP cells produces a functional protein in large scale 2. Development of a microcarrier coated with LN-521 Methods: Screen different hydrogels, make beads and culture hPSCs Analysis: Optimal material found. Bead manufacturing hard. Another product in pipe 3. Optimization of hPSC bioreactor culture conditions Methods: Set specs in small scale but for multiple bioreactors Analysis: Optimal protocol set 4. Pre-production Not initiated