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Process Design for Stem Cell Therapy Design, Growth, Harvest and Manufacturing

Merck is deeply committed to sharing our expertise and help you build your own stem cell manufacturing science—critical for process transferability.

Process Design for Stem Cell Therapy Design, Growth, Harvest and ManufacturingAs 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:

  • Know the drug product’s critical quality attributes
  • Identify key process parameters for scalability
  • Increase cell yield to help decrease cost of goods
  • Achieve a safe and sustainable supply

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.

Process Development Services

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.