**Author details**

*New Advances on Fermentation Processes*

necessary.

**Acknowledgements**

**Conflict of interest**

protocols, it is unclear whether MSC products are similar enough across manufacturing sites and whether results can be considered comparable even within the same study. Moreover, the incomplete definition of MSCs makes it difficult to develop objective release criteria. These issues strongly argue for the harmonization and standardization of MSC manufacturing processes, release criteria, and potency assays. The regulatory standards for MSCs are still evolving, and different standards apply in different jurisdictions. MSCs are living cells and cannot be held to the same standards as chemical entities or biopharmaceuticals, both of which can be tested against rigorous and objective quality criteria. The regulations for MSCs should be more flexible, acknowledging that each MSC product is developed for a specific indication, and unique platform technologies, CQAs, and CPPs may therefore be necessary for each manufacturing process. One of the most important platform technologies is the use of bioreactors for cell expansion, because this is the only current strategy that can bring MSC therapy into routine practice. MSCs can also be used as production aids for other products, including beta cells for drug screening or diabetes therapy, and novel biological agents such as extracellular vesicles. In the future, they could even be used for commodity products such as artificial meat. But in all these applications, a robust and scalable manufacturing process will be

We would like to thank the Hessen State Ministry of Higher Education, Research

and the Arts for the financial support within the Hessen initiative for scientific and economic excellence (LOEWE-Program, LOEWE Center DRUID (Novel Drug Targets against Poverty-Related and Neglected Tropical Infectious Diseases)). We also received financial support from the Strategic Research Fund of the THM

(University of Applied Sciences Mittelhessen). The authors acknowledge

Dr. Richard M Twyman for revising the paper.

The authors declare no conflict of interest.

**218**

Jan Barekzai1 , Florian Petry1 , Jan Zitzmann1 , Peter Czermak1,2,3 and Denise Salzig1 \*

1 Institute of Bioprocess Engineering and Pharmaceutical Technology, University of Applied Sciences Mittelhessen, Giessen, Germany

2 Faculty of Biology and Chemistry, Justus-Liebig-University Giessen, Giessen, Germany

3 Project Group Bioresources, Fraunhofer Institute for Molecular Biology and Applied Ecology (IME), Giessen, Germany

\*Address all correspondence to: denise.salzig@lse.thm.de

© 2019 The Author(s). Licensee IntechOpen. This chapter is distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/ by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
