Serum-free process development: Improving the yield and consistency of human mesenchymal stromal cell production

Cytotherapy

Volumn 17, Issue 11, 2015, Pages 1524-1535

  Heathman, Thomas R J ^a   Stolzing, Alexandra ^a   Fabian, Claire ^b,c   Rafiq, Qasim A ^a,d   Coopman, Karen ^a   Nienow, Alvin W ^a,e   Kara, Bo ^f   Hewitt, Christopher J ^a,d  

^a LOUGHBOROUGH UNIVERSITY   (United Kingdom)

^b FRAUNHOFER INSTITUTE FOR CELL THERAPY AND IMMUNOLOGY   (Germany)

^c UNIVERSITY OF LEIPZIG   (Germany)

^d ASTON UNIVERSITY   (United Kingdom)

^e UNIVERSITY OF BIRMINGHAM   (United Kingdom)

^f Fujifilm Diosynth Biotechnologies   (United Kingdom)

Author keywords

Cell based therapy; Comparability; Consistency; Human mesenchymal stromal cell; Manufacturing; Regenerative medicine; Serum free; Yield

Indexed keywords

RNA; CULTURE MEDIUM;

ANALYTIC METHOD; ARTICLE; BONE DEVELOPMENT; BONE MARROW; BONE MARROW DERIVED MESENCHYMAL STROMA CELL; CELL EXPANSION; CELL PROLIFERATION; COLONY FORMING UNIT; CONTROLLED STUDY; CULTURE MEDIUM; FIBROBLAST; GENE EXPRESSION; GROWTH RATE; HUMAN; HUMAN CELL; IN VITRO STUDY; MESENCHYMAL STROMA CELL; METABOLITE; MONOLAYER CULTURE; PRIORITY JOURNAL; PROCESS DEVELOPMENT; REAL TIME POLYMERASE CHAIN REACTION; RNA ISOLATION; SENESCENCE; BONE MARROW CELL; CELL CULTURE TECHNIQUE; CELL DIFFERENTIATION; CELL SIZE; CHEMISTRY; CYTOLOGY; PHYSIOLOGY; PROCEDURES;

BONE MARROW CELLS; CELL CULTURE TECHNIQUES; CELL DIFFERENTIATION; CELL PROLIFERATION; CELL SIZE; CULTURE MEDIA; GENE EXPRESSION; HUMANS; MESENCHYMAL STROMAL CELLS; OSTEOGENESIS;

EID: 84942546670     PISSN: 14653249     EISSN: 14772566     Source Type: Journal    
DOI: 10.1016/j.jcyt.2015.08.002     Document Type: Article

References (39)

1. Heathman T.R.J., Nienow A.W., McCall M.J., Coopman K., Kara B., Hewitt C.J. The translation of cell-based therapies: clinical landscape and manufacturing challenges. Regen Med 2015, 10:49-64.
2. Carmen J., Burger S.R., McCaman M., Rowley J.A. Developing assays to address identity, potency, purity and safety: cell characterization in cell therapy process development. Regen Med 2012, 7:85-100.
3. Hourd P., Chandra A., Medcalf N., Williams D.J. Regulatory challenges for the manufacture and scale-out of autologous cell therapies. StemBook 2014, Paul Hourd, Amit Chandra, Nick Medcalf and David J. Williams, Cambridge MA, 2014.
4. Heathman TRJ, Rafiq QA, Chan AKC, Coopman K, Nienow AW, Kara B, et al. Characterization of human mesenchymal stem cells from multiple donors and the implications for large scale bioprocess development. Biochem Engineer J 205 (Epub ahead of print ). http://dx.doi.org/10.1016/j.bej.2015.06.018.
5. Estrada J.C., Torres Y., Benguria A., Dopazo A., Roche E., Carrera-Quintanar L., et al. Human mesenchymal stem cell-replicative senescence and oxidative stress are closely linked to aneuploidy. Cell Death Dis 2013, 4:e691.
6. Golpanian S., El-Khorazaty J., Mendizabal A., DiFede D.L., Suncion V.Y., Karantalis V., et al. Effect of aging on human mesenchymal stem cell therapy in ischemic cardiomyopathy patients. J Am Coll Cardiol 2015, 65:125-132.
7. Kadri N., Potiron N., Ouary M., Jegou D., Gouin E., Bach J.M., et al. Fetal calf serum-primed dendritic cells induce a strong anti-fetal calf serum immune response and diabetes protection in the non-obese diabetic mouse. Immunol Lett 2007, 108:129-136.
8. Haase C., Ejrnaes M., Juedes A.E., Wolfe T., Markholst H., von Herrath M.G. Immunomodulatory dendritic cells require autologous serum to circumvent nonspecific immunosuppressive activity in vivo. Blood 2005, 106:4225-4233.
9. Williams D.J., Thomas R.J., Hourd P.C., Chandra A., Ratcliffe E., Liu Y., et al. Precision manufacturing for clinical-quality regenerative medicines. Philos Trans A Math Phys Eng Sci 2012, 370:3924-3949.
10. Wappler J., Rath B., Laufer T., Heidenreich A., Montzka K. Eliminating the need of serum testing using low serum culture conditions for human bone marrow-derived mesenchymal stromal cell expansion. Biomed Eng Online 2013, 12:15.
11. Brindley D.A., Davie N.L., Culme-Seymour E.J., Mason C., Smith D.W., Rowley J.A. Peak serum: implications of serum supply for cell therapy manufacturing. Regen Med 2012, 7:7-13.
12. Spees J.L., Gregory C.A., Singh H., Tucker H.A., Peister A., Lynch P.J., et al. Internalized antigens must be removed to prepare hypoimmunogenic mesenchymal stem cells for cell and gene therapy, Molecular therapy. Mol Ther 2004, 9:747-756.
13. Heathman T.R.J., Glyn V.A.M., Picken A., Rafiq Q.A., Coopman K., Nienow A.W., et al. Expansion, harvest and cryopreservation of human mesenchymal stem cells in a serum-free microcarrier process. Biotechnol Bioeng 2015, 112:1696-1707.
14. dos Santos F., Andrade P.Z., Abecasis M.M., Gimble J.M., Chase L.G., Campbell A.M., et al. Toward a Clinical-Grade Expansion of Mesenchymal Stem Cells from Human Sources: A Microcarrier-Based Culture System Under Xeno-Free Conditions. Tissue Eng Part C Methods 2011, 17:1201-1210.
15. Chan A.K., Heathman T.R., Coopman K., Hewitt C.J. Multiparameter flow cytometry for the characterisation of extracellular markers on human mesenchymal stem cells. Biotechnol Lett 2014, 36:731-741.
16. Maziarz R.T., Devos T., Bachier C.R., Goldstein S.C., Leis J.F., Devine S.M., et al. Single and multiple dose MultiStem (multipotent adult progenitor cell) therapy prophylaxis of acute graft-versus-host disease in myeloablative allogeneic hematopoietic cell transplantation: a phase 1 trial. Biol Blood Marrow Transplant 2015, 21:720-728.
17. Prasad V.K., Lucas K.G., Kleiner G.I., Talano J.A., Jacobsohn D., Broadwater G., et al. Efficacy and safety of ex vivo cultured adult human mesenchymal stem cells (Prochymal) in pediatric patients with severe refractory acute graft-versus-host disease in a compassionate use study. Biol Blood Marrow Transplant 2011, 17:534-541.
18. Jorgensen P., Tyers M. How cells coordinate growth and division. Curr Biol 2004, 14:R1014-R1027.
19. Deskins D.L., Bastakoty D., Saraswati S., Shinar A., Holt G.E., Young P.P. Human Mesenchymal Stromal Cells: Identifying Assays to Predict Potency for Therapeutic Selection. Stem Cells Transl Med 2013, 2:151-158.
20. Christodoulou I., Kolisis F.N., Papaevangeliou D., Zoumpourlis V. Comparative Evaluation of Human Mesenchymal Stem Cells of Fetal (Wharton's Jelly) and Adult (Adipose Tissue) Origin during Prolonged In Vitro Expansion: Considerations for Cytotherapy. Stem Cells Int 2013, 2013:246134.
21. Majore I., Moretti P., Hass R., Kasper C. Identification of subpopulations in mesenchymal stem cell-like cultures from human umbilical cord, Cell Communication and Signaling. Cell Commun Signal 2009, 7:6.
22. Wagner W., Ho A.D., Zenke M. Different facets of aging in human mesenchymal stem cells. Tissue Eng Part B Rev 2010, 16:445-453.
23. Stolzing A., Scutt A. Age-related impairment of mesenchymal progenitor cell function. Aging cell 2006, 5:213-224.
24. Cheuvront S.N., Kenefick R.W., Heavens K.R., Spitz M.G. A Comparison of Whole Blood and Plasma Osmolality and Osmolarity. J Clin Lab Anal 2014, 28:368-373.
25. Ge J., Guo L., Wang S., Zhang Y., Cai T., Zhao R.C., et al. The size of mesenchymal stem cells is a significant cause of vascular obstructions and stroke. Stem Cell Rev 2014, 10:295-303.
26. Cui L.L., Kerkela E., Bakreen A., Nitzsche F., Andrzejewska A., Nowakowski A., et al. The cerebral embolism evoked by intra-arterial delivery of allogeneic bone marrow mesenchymal stem cells in rats is related to cell dose and infusion velocity. Stem Cell Res Ther 2015, 6:11.
27. Moelker A.D., Baks T., Wever K.M., Spitskovsky D., Wielopolski P.A., van Beusekom H.M., et al. Intracoronary delivery of umbilical cord blood derived unrestricted somatic stem cells is not suitable to improve LV function after myocardial infarction in swine. J Mol Cell Cardiol 2007, 42:735-745.
28. Janowski M., Lyczek A., Engels C., Xu J., Lukomska B., Bulte J.W., et al. Cell size and velocity of injection are major determinants of the safety of intracarotid stem cell transplantation. J Cereb Blood Flow Metab 2013, 33:921-927.
29. Veevers-Lowe J., Ball S.G., Shuttleworth A., Kielty C.M. Mesenchymal stem cell migration is regulated by fibronectin through alpha5beta1-integrin-mediated activation of PDGFR-beta and potentiation of growth factor signals. J Cell Sci 2011, 124:1288-1300.
30. Breyer A., Estharabadi N., Oki M., Ulloa F., Nelson-Holte M., Lien L., et al. Multipotent adult progenitor cell isolation and culture procedures. Exp Hematol 2006, 34:1596-1601.
31. Bianco P., Cao X., Frenette P.S., Mao J.J., Robey P.G., Simmons P.J., et al. The meaning, the sense and the significance: translating the science of mesenchymal stem cells into medicine. Nat Med 2013, 19:35-42.
32. von Bahr L., Batsis I., Moll G., Hagg M., Szakos A., Sundberg B., et al. Analysis of tissues following mesenchymal stromal cell therapy in humans indicates limited long-term engraftment and no ectopic tissue formation. Stem cells 2012, 30:1575-1578. (Dayton, Ohio).
33. Rowley J., Abraham E., Campbell A., Brandwein H., Oh S. Meeting Lot-Size Challenges of Manufacturing Adherent Cells for Therapy. BioProcess International 2012, 10:16-22.
34. Jung S., Sen A., Rosenberg L., Behie L.A. Identification of growth and attachment factors for the serum-free isolation and expansion of human mesenchymal stromal cells. Cytotherapy 2010, 12:637-657.
35. Wagner W., Feldmann R.E., Seckinger A., Maurer M.H., Wein F., Blake J., et al. The heterogeneity of human mesenchymal stem cell preparations-evidence from simultaneous analysis of proteomes and transcriptomes. Exp Hematol 2006, 34:536-548.
36. Guilloton F., Caron G., Menard C., Pangault C., Ame-Thomas P., Dulong J., et al. Mesenchymal stromal cells orchestrate follicular lymphoma cell niche through the CCL2-dependent recruitment and polarization of monocytes. Blood 2012, 119:2556-2567.
37. Riekstina U., Cakstina I., Parfejevs V., Hoogduijn M., Jankovskis G., Muiznieks I., et al. Embryonic stem cell marker expression pattern in human mesenchymal stem cells derived from bone marrow, adipose tissue, heart and dermis. Stem Cell Rev 2009, 5:378-386.
38. Beckermann B.M., Kallifatidis G., Groth A., Frommhold D., Apel A., Mattern J., et al. VEGF expression by mesenchymal stem cells contributes to angiogenesis in pancreatic carcinoma. Br J Cancer 2008, 99:622-631.
39. Gao F., He T., Wang H., Yu S., Yi D., Liu W., et al. A promising strategy for the treatment of ischemic heart disease: Mesenchymal stem cell-mediated vascular endothelial growth factor gene transfer in rats. Can J Cardiol 2007, 23:891-898.