Director of Product Solutions Mytos, England, United Kingdom
Abstract: Pluripotent stem cells (PSCs) are revolutionizing regenerative medicine, yet their transition to commercialization is hindered by labor-intensive protocols and complex scaling processes. Protocols are typically developed manually in a flask-based format, and scaled by increasing operators or using 3D bioreactors for commercial production. The Mytos iDEM platform addresses these challenges by automating iPSC culture and differentiation in a closed, flask-based system, seamlessly translating manual protocols to scalable, GMP-compliant production leading to faster route to scale. In this study, we demonstrate the iDEM’s versatility by automating two differentiations: hematopoietic progenitor cells (HPCs) and dopaminergic neurons (DAs). HPCs were generated using Stemcell Technologies’ StemdiffTM Hematopoietic kit, achieving consistent yields and marker expression (9.5x106 HPCs per T175 with the expression levels of CD34+ >95%, CD45+ >60%, SSEA4+ < 5% and TRA-181+ < 5%, n=2). DAs were produced using a previously published protocol (Kriks et al. 2011), yielding over 95% viable cells with comparable quality to manual differentiation assessed by flow cytometry (Tuj1+>95%, FOXA2+>95%, MAP2+>80 and TH+>65%, n=3). Additionally, on-going proof-of-concept studies differentiating iPSCs into RPE cells will highlight the platform’s advantages for extended protocols. The iDEM platform simplifies scale-up by reducing variability, minimizing manual intervention, and ensuring culture integrity in a closed system. By enabling robust, scalable differentiation workflows, it accelerates the path to commercialization, providing regenerative medicine developers with a powerful tool to bring cell-based therapies to the clinic faster.
