References

1. Pittenger MF, Mackay AM, Beck SC et al

(1999) Multilineage potential of adult human

mesenchymal

stem

cells.

Science

284:143–147.

https://doi.org/10.1126/sci

ence.284.5411.143

2. Lange C, Cakiroglu F, Spiess A-N et al (2007)

Accelerated and safe expansion of human mes-

enchymal stromal cells in animal serum-free

medium for transplantation and regenerative

medicine. J Cell Physiol 213:18–26. https://

doi.org/10.1002/jcp.21081

3. Han C, Sun X, Liu L et al (2016) Exosomes

and their therapeutic potentials of stem cells.

Stem Cells Int 2016:1–11. https://doi.org/

10.1155/2016/7653489

4. Zhou Y, Yamamoto Y, Xiao Z, Ochiya T

(2019) The immunomodulatory functions of

mesenchymal stromal/stem cells mediated via

paracrine activity. J Clin Med 8:1025. https://

doi.org/10.3390/jcm8071025

5. Mohammadalipour A, Dumbali SP, Wenzel PL

(2020) Mitochondrial transfer and regulators

of mesenchymal stromal cell function and ther-

apeutic efficacy. Front Cell Dev Biol 8:603292.

https://doi.org/10.3389/fcell.2020.603292

6. Jossen V (2020) Bioengineering aspects of

microcarrier-based hMSC expansions in differ-

ent single-use bioreactors. Doctoral Thesis,

Technische Universitat Berlin

7. Guldager N Realizing the cost advantages of

single-use technology. In: TechTalk https://

www.nne.com/techtalk/Realizing-the-cost-

advantages-of-single-use-technology/.

Accessed 30 May 2021

8. Eibl D, Eibl R (2019) Single-use equipment in

biopharmaceutical manufacture: a brief intro-

duction, 2nd edn. Wiley, Hoboken, NJ

9. Bestwick D, Colton R Extractables and leach-

ables from single-use disposables. In: BioPro-

cess

Int

https://bioprocessintl.com/2009/

extractables-and-leachables-from-single-use-

disposables-184117/. Accessed 30 May 2021

10. Soban´tka A, Weiner C (2019) Extractables/

Leachables from single-use equipment: consid-

erations from a (bio)pharmaceutical manufac-

turer.

In:

Single-use

technology

in

biopharmaceutical

manufacture,

2nd

edn.

Wiley, Hoboken, NJ, pp 143–158

11. Ding W, Madsen G, Mahajan E et al (2014)

Standardized extractables testing protocol for

single-use systems in biomanufacturing. Pharm

Eng 34:74–85

12. Eibl R, Steiger N, Fritz C et al (2014) Recom-

mendation for leachable studies: standardized

cell culture test for the early identification of

critical films for CHO cell lines in chemically

defined culture media. https://dechema.de/

en/Research/Reports+and+position+papers/

2014+Recommendation+for+Leachables

+Studies+_+Standardized+cell+culture+test

+for+the+early+identification+of+critical

+films-p-136200.html. Accessed 30 May 2021

13. DePalma A (2017) Extractables and leachables:

standardizing approaches to manage the risk.

In:

Bioprocess

Int.

https://bioprocessintl.

com/analytical/leachables-extractables-

particulates/extractables-and-leachables-

standardizing-approaches-to-manage-the-

risk/

14. ASTM E3231–19 (2019) Standard guide for

cell culture growth assessment of single-use

material. ASTM International, West Consho-

hocken, PA

15. Oosterhuis NMG (2018) Single-use bioreac-

tors for continuous bioprocessing: challenges

and outlook. In: Continuous biomanufactur-

ing: innovative technologies and methods, 1st

edn. Wiley-VCH Verlag GmbH & Co. KGaA.,

Weinheim, pp 131–148

16. Jossen V, Eibl R, Eibl D (2019) Single-use

bioreactors–an overview. In: Single-use tech-

nology

in

biopharmaceutical

manufacture,

2nd edn. Wiley, Hoboken, NJ, pp 37–52

17. Reichardt A, Polchow B, Shakibaei M et al

(2013) Large scale expansion of human umbil-

ical cord cells in a rotating bed system bioreac-

tor

for

cardiovascular

tissue

engineering

applications. Open Biomed Eng J 7:50–61.

https://doi.org/10.2174/

1874120701307010050

18. Layer PG, Robitzki A, Rothermel A, Willbold

E (2002) Of layers and spheres: the reaggregate

approach in tissue engineering. Trends Neu-

rosci 25:131–134. https://doi.org/10.1016/

S0166-2236(00)02036-1

19. Bartosh TJ, Ylo¨stalo JH, Mohammadipoor A

et al (2010) Aggregation of human mesenchy-

mal stromal cells (MSCs) into 3D spheroids

enhances their antiinflammatory properties.

Proc

Natl

Acad

Sci

107:13724–13729.

https://doi.org/10.1073/pnas.1008117107

20. Cheng N-C, Chen S-Y, Li J-R, Young T-H

(2013)

Short-term

spheroid

formation

enhances the regenerative capacity of adipose-

derived stem cells by promoting stemness,

angiogenesis,

and

chemotaxis.

Stem

Cells

Transl Med 2:584–594. https://doi.org/10.

5966/sctm.2013-0007

21. Ylo¨stalo JH, Bartosh TJ, Coble K, Prockop DJ

(2012) Human mesenchymal stem/stromal

Mesenchymal Stem Cell Expansion at Benchtop-Scale

109