Mesenchymal stem cells (MSCs) are able to self-renew and differentiate into a wide variety of tissues. These multipotent cells are being leveraged against a wide range of diseases, including autoimmune diseases, graft-versus-host disease, and acute myocardial infarction. In order to generate sufficient quantities of cells for clinical applications, MSCs must be transitioned from static cultures to scalable suspension cultures grown in bioreactors. This transfer has traditionally represented a bottleneck during process development. The Sartorius MSC Exploration and Characterization Solution enables rapid MSC process development thus accelerating time-to-market. The experiments presented here demonstrate the critical role of Ambr® 15 Cell Culture system and MODDE® Design of Experiments (DOE) software, as part of the Sartorius MSC Exploration and Characterization Solution, in the development of process knowledge. The use of automated, controlled, multi-parallel experimental setup and DOE analysis results in rapid identification and optimization of critical process parameters (CPPs).

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