References
1. Grand View Research (2020) Cell therapy market size, share and trends analysis report,
2020–2027
2. Malik NN, Durdy MB (2015) Cell therapy landscape. In: Translational regenerative medicine.
Elsevier, pp 87–106
3. Simaria AS, Hassan S, Varadaraju H, Rowley J, Warren K, Vanek P, Farid SS (2014)
Allogeneic cell therapy bioprocess economics and optimization: single-use cell expansion
technologies. Biotechnol Bioeng 111:69–83. https://doi.org/10.1002/bit.25008
4. Sharma S, Raju R, Sui S, Hu W-S (2011) Stem cell culture engineering – process scale up and
beyond. Biotechnol J 6:1317–1329. https://doi.org/10.1002/biot.201000435
5. Ren G, Chen X, Dong F, Li W (2012) Concise review: mesenchymal stem cells and
translational medicine: emerging issues. Stem Cells Transl Med 1:51–58
6. Capelli C, Pedrini O, Valgardsdottir R, Da Roit F, Golay J, Introna M (2015) Clinical grade
expansion of MSCs. Immunol Lett 168:222–227. https://doi.org/10.1016/j.imlet.2015.06.006
7. Wagner W, Horn P, Castoldi M, Diehlmann A, Bork S, Saffrich R, Benes V, Blake J, Pfister S,
Eckstein V, Ho AD (2008) Replicative senescence of mesenchymal stem cells: a continuous
and organized process. PLoS One 3:e2213. https://doi.org/10.1371/journal.pone.0002213
8. Lo Surdo J, Bauer SR (2012) Quantitative approaches to detect donor and passage differences
in adipogenic potential and clonogenicity in human bone marrow-derived mesenchymal stem
cells. Tissue Eng Part C Methods 18:877–889. https://doi.org/10.1089/ten.tec.2011.0736
9. Heathman TRJ, Rafiq QA, Chan AKC, Coopman K, Nienow AW, Kara B, Hewitt CJ (2016)
Characterization of human mesenchymal stem cells from multiple donors and the implications
for large scale bioprocess development. Biochem Eng J 108:14–23. https://doi.org/10.1016/j.
bej.2015.06.018
10. Das R, Roosloot R, van Pel M, Schepers K, Driessen M, Fibbe WE, de Bruijn JD, Roelofs H
(2019) Preparing for cell culture scale-out: establishing parity of bioreactor- and flaskexpanded mesenchymal stromal cell cultures. J Transl Med 17:241. https://doi.org/10.1186/
s12967-019-1989-x
11. Jossen V, Schirmer C, Mostafa Sindi D, Eibl R, Kraume M, Pörtner R, Eibl D (2016)
Theoretical and practical issues that are relevant when scaling up hMSC microcarrier production processes. Stem Cells Int 2016:1–15. https://doi.org/10.1155/2016/4760414
12. Jossen V, Eibl R, Kraume M, Eibl D (2018) Growth behavior of human adipose tissue-derived
stromal/stem cells at small scale: numerical and experimental investigations. Bioengineering
5:106. https://doi.org/10.3390/bioengineering5040106
13. Hassan S, Simaria AS, Varadaraju H, Gupta S, Warren K, Farid SS (2015) Allogeneic cell
therapy bioprocess economics and optimization: downstream processing decisions. Regen
Med 10:591–609
14. Lipsitz YY, Milligan WD, Fitzpatrick I, Stalmeijer E, Farid SS, Tan KY, Smith D, Perry R,
Carmen J, Chen A, Mooney C, Fink J (2017) A roadmap for cost-of-goods planning to guide
economic production of cell therapy products. Cytotherapy 19:1383–1391. https://doi.org/10.
1016/j.jcyt.2017.06.009
15. García-Fernández C, López-Fernández A, Borrós S, Lecina M, Vives J (2020) Strategies for
large-scale expansion of clinical-grade human multipotent mesenchymal stromal cells.
Biochem Eng J 159:107601. https://doi.org/10.1016/j.bej.2020.107601
16. Dolley-Sonneville P, Melkoumian Z, Romeo L. Corning
® Stemgro
® hMSC Medium. Corning
Appl Note 1–8
17. Gottipamula S, Muttigi MS, Chaansa S, Ashwin KM, Priya N, Kolkundkar U, Sundar Raj S,
Sen MA, Seetharam RN (2016) Large-scale expansion of pre-isolated bone marrow mesenchymal stromal cells in serum-free conditions. J Tissue Eng Regen Med 10:108–119. https://
doi.org/10.1002/term.1713
222
V. Jossen et al.
1. Grand View Research (2020) Cell therapy market size, share and trends analysis report,
2020–2027
2. Malik NN, Durdy MB (2015) Cell therapy landscape. In: Translational regenerative medicine.
Elsevier, pp 87–106
3. Simaria AS, Hassan S, Varadaraju H, Rowley J, Warren K, Vanek P, Farid SS (2014)
Allogeneic cell therapy bioprocess economics and optimization: single-use cell expansion
technologies. Biotechnol Bioeng 111:69–83. https://doi.org/10.1002/bit.25008
4. Sharma S, Raju R, Sui S, Hu W-S (2011) Stem cell culture engineering – process scale up and
beyond. Biotechnol J 6:1317–1329. https://doi.org/10.1002/biot.201000435
5. Ren G, Chen X, Dong F, Li W (2012) Concise review: mesenchymal stem cells and
translational medicine: emerging issues. Stem Cells Transl Med 1:51–58
6. Capelli C, Pedrini O, Valgardsdottir R, Da Roit F, Golay J, Introna M (2015) Clinical grade
expansion of MSCs. Immunol Lett 168:222–227. https://doi.org/10.1016/j.imlet.2015.06.006
7. Wagner W, Horn P, Castoldi M, Diehlmann A, Bork S, Saffrich R, Benes V, Blake J, Pfister S,
Eckstein V, Ho AD (2008) Replicative senescence of mesenchymal stem cells: a continuous
and organized process. PLoS One 3:e2213. https://doi.org/10.1371/journal.pone.0002213
8. Lo Surdo J, Bauer SR (2012) Quantitative approaches to detect donor and passage differences
in adipogenic potential and clonogenicity in human bone marrow-derived mesenchymal stem
cells. Tissue Eng Part C Methods 18:877–889. https://doi.org/10.1089/ten.tec.2011.0736
9. Heathman TRJ, Rafiq QA, Chan AKC, Coopman K, Nienow AW, Kara B, Hewitt CJ (2016)
Characterization of human mesenchymal stem cells from multiple donors and the implications
for large scale bioprocess development. Biochem Eng J 108:14–23. https://doi.org/10.1016/j.
bej.2015.06.018
10. Das R, Roosloot R, van Pel M, Schepers K, Driessen M, Fibbe WE, de Bruijn JD, Roelofs H
(2019) Preparing for cell culture scale-out: establishing parity of bioreactor- and flaskexpanded mesenchymal stromal cell cultures. J Transl Med 17:241. https://doi.org/10.1186/
s12967-019-1989-x
11. Jossen V, Schirmer C, Mostafa Sindi D, Eibl R, Kraume M, Pörtner R, Eibl D (2016)
Theoretical and practical issues that are relevant when scaling up hMSC microcarrier production processes. Stem Cells Int 2016:1–15. https://doi.org/10.1155/2016/4760414
12. Jossen V, Eibl R, Kraume M, Eibl D (2018) Growth behavior of human adipose tissue-derived
stromal/stem cells at small scale: numerical and experimental investigations. Bioengineering
5:106. https://doi.org/10.3390/bioengineering5040106
13. Hassan S, Simaria AS, Varadaraju H, Gupta S, Warren K, Farid SS (2015) Allogeneic cell
therapy bioprocess economics and optimization: downstream processing decisions. Regen
Med 10:591–609
14. Lipsitz YY, Milligan WD, Fitzpatrick I, Stalmeijer E, Farid SS, Tan KY, Smith D, Perry R,
Carmen J, Chen A, Mooney C, Fink J (2017) A roadmap for cost-of-goods planning to guide
economic production of cell therapy products. Cytotherapy 19:1383–1391. https://doi.org/10.
1016/j.jcyt.2017.06.009
15. García-Fernández C, López-Fernández A, Borrós S, Lecina M, Vives J (2020) Strategies for
large-scale expansion of clinical-grade human multipotent mesenchymal stromal cells.
Biochem Eng J 159:107601. https://doi.org/10.1016/j.bej.2020.107601
16. Dolley-Sonneville P, Melkoumian Z, Romeo L. Corning
® Stemgro
® hMSC Medium. Corning
Appl Note 1–8
17. Gottipamula S, Muttigi MS, Chaansa S, Ashwin KM, Priya N, Kolkundkar U, Sundar Raj S,
Sen MA, Seetharam RN (2016) Large-scale expansion of pre-isolated bone marrow mesenchymal stromal cells in serum-free conditions. J Tissue Eng Regen Med 10:108–119. https://
doi.org/10.1002/term.1713
222
V. Jossen et al.