Bioprocessing for Cell-Based Therapies by Che J. Connon

Author:Che J. Connon
Language: eng
Format: epub
ISBN: 9781118743409
Publisher: John Wiley & Sons, Inc.
Published: 2016-11-18T00:00:00+00:00

Figure 4.5 Phase-contrast image of microcarrier and cell suspension after dissociation during the novel harvesting procedure. Magnification 10x. Arrows: (a) Single hMSC successfully detached from microcarrier; and (b) hMSCs still attached to microcarrier (Nienow et al., 2014).

4.8 Conclusions

It is clear that for autologous therapies a scale-out approach may be appropriate using automated cell culture platforms as demonstrated successfully by others, but for allogeneic therapies it is likely that larger-scale bioprocesses will be required. Our work has demonstrated the feasibility of a scalable microcarrier process for the expansion and harvest of hMSCs in conventional stirred tank bioreactors. The integration of multiple process unit operations is an important step in developing a microcarrier-based expansion process capable of meeting the lot sizes required for clinical applications. hMSC identity and quality have been maintained throughout every unit operation of this integrated process, culminating with the successful harvest of hMSCs from the microcarriers and spent culture broth at the end of the expansion process. In addition, we have quantified the important bioprocessing metabolites under static and agitated culture conditions that can be used to inform further scale-up. However, it is our contention that we are still in the “foothills” for stem cell bioprocess development. Globally there are relatively very few academic or industrial groups working on developing such bioprocesses, when compared to the numbers of groups working on the basic biology of such cells. If the therapeutic potential of stem cells is ever to be realised, then we need fully defined scalable upstream expansion processes, downstream separation technologies and suitable cell preservation strategies that will de-couple cell expansion from delivery to the patient. In order to do this, there needs to be greater collaboration between engineers, scientists and medical professionals.

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