Sep 20, 2018
Human mesenchymal stem cells (MSCs) have received great medical interest as a new treatment option and spurred a new age in regenerative medicine. However, conventional cultivation on plasticwares and in suspensions are difficult to scale-up production of MSCs for clinical applications. To overcome these challenges, Esco Aster has leveraged on Tide Motion bioreactors to develop a scalable bioprocess operation for the production of MCSs in a Current Good Manufacturing Practices (cGMP) compliant process. Human MSCs isolated from healthy donors were expanded in conventional 2D adherent cultures for a few passages before seeding into macrocarriers (BioNOC™ II) in a CelCradle™ bottle. The cells were grown in chemically defined media and harvesting efficiencies of more than 90% were achieved, with cell viabilities greater than 85% after 5-7 days in culture. In accordance to International Society for Cellular Therapy (ISCT), quality control and release criteria for MSCs characterized by their surface markers and multipotency (adipogenic, osteogenic and chondrogenic differentiations) ensured more than 95% of MSCs in culture. Importantly, MSCs cultured on the BioNOC™ II displayed similar in vivo characteristics, with secretions of extracellular matrix (ECM) proteins and fibroblastic morphological changes. Our current process is robust, relying on standard bioprocessing tools in most contract manufacturing facilities (CMOs). Through monitoring and optimization of key process parameters, such as pH, glucose consumption rates, we aim to easily translate lab scale production from academic/industrial R&D into bench scale/ pilot scale of clinical trials and commercial production.
MONITORING MSCs EXPANSION IN CELCRADLE™
QUALITY CONTROL & RELEASE CRITERIA