As more stem cells types require scale-up to generate large quantities of high-quality cells for clinical dosing, developing a platform process for these cell types will aid faster process development.
Because manufacturers must balance speed to clinic while ensuring long-term commercial viability of cell therapy products, it is critical that they:
Our dedicated experts in stem cell design and stem cell manufacturing have developed a successful approach to transition manufacturing processes for adherent cells (e.g. Mesenchymal stem cells) from static flat culture to microcarrier-based culture in single-use bioreactors from 3L to 50L and 200L scales.
Because bioreactors produce large cell culture volumes and improved cell yields, they drive production costs down. Furthermore, automation and closed systems associated with single-use bioreactor platforms improve the consistency and robustness of autologous and allogeneic products.
A specific set of operating parameters must be generated for each cell/microcarrier/cell culture medium media combination. In partnership with customers, Merck offers Process Development Services to design an Optimized Process Operating Window for each manufacturing process.