Scientists from the Hannover Medical School are coordinating the €6m ($7M) TECHNOBEAT project, a four year European funded research collaboration hoping to develop therapies for heart disease using hiPSCs.
As part of the team, Eppendorf has been selected to develop bioreactor solutions for cultivating large-scale stem cells from its Bioprocess Center facility and its subsidiary Dasgip, both situated in Juelich, Germany.
Scaling-up production for commercial use is a burgeoning problem for industry as more regenerative medicines enter later-stage development, and a recent US Government report has high-lighted the critical need to develop bioprocesses to achieve manufacturing reproducibility of such cells.
Stem cell manufacturing
“Stem cells are much trickier to cultivate than, say, CHO cells,” scientific communication manager Ulrike Becken told Biopharma-Reporter.com. “Cultivation of stem cells demands special process conditions and a level of cell monitoring that might be not required for the production of a monoclonal antibody, and the bioreactors used must accommodate this.”
He explained: “Induced pluripotent stem cells are very shear sensitive, and they do not grow as a single-cell suspension but must be cultivated as cell aggregates or on microcarriers.”
Furthermore “stem cells have to maintain pluripotency and their potential to differentiate, and then have to be differentiated into the desired cell type,” he continued, adding various factors including shear forces, oxygen tension, and pH, influence this.
Eppendorf has already begun tackling these issues through the development of an impeller optimised for stem cell cultivation in stirred-tank bioreactors, but for the TECHNOBEAT project the firm hopes to take strides toward commercial size bioreactors that allow the integration of analytical technology.
“The challenge is to adapt the technology that was and is developed at small scales, to the needs of stem cell cultivation in larger volumes,” Becken said.
“Large-scale cultivation of stem cells is far away from being routine and Eppendorf strives to improve the options for streamlined stem cell production.”
He added the firm also has to think about the implementation of perfusion technology, and single-use bioreactors for GMP-conform production.