Current understanding and challenges in bioprocessing of stem cell-based therapies for regenerative medicine

British Medical Bulletin

Volumn 100, Issue 1, 2011, Pages 137-155

  Ratcliffe, Elizabeth ^a   Thomas, Robert J ^a   Williams, David J ^a  

^a LOUGHBOROUGH UNIVERSITY   (United Kingdom)

Author keywords

bioprocessing; cell culture automation; cell based therapy; manufacture; quality engineering; regenerative medicine

Indexed keywords

ARTICLE; BIOPROCESS; CELL CULTURE; CELL THERAPY; GOOD MANUFACTURING PRACTICE; PRIORITY JOURNAL; REGENERATIVE MEDICINE; STEM CELL TRANSPLANTATION;

AUTOMATION; HUMANS; REGENERATIVE MEDICINE; STEM CELL TRANSPLANTATION; TISSUE ENGINEERING; TRANSLATIONAL MEDICAL RESEARCH;

EID: 83255189657     PISSN: 00071420     EISSN: 14718391     Source Type: Journal    
DOI: 10.1093/bmb/ldr037     Document Type: Article

References (54)

1. Mason C, Dunhill P. A brief definition of regenerative medicine. Regen Med 2008;3:1-5. (Pubitemid 351541190)
2. Nerem R. Regenerative medicine: the emergence of an industry. J R Soc Interface 2010;7:S771-75.
3. Mimeault M, Hauke R, Batra SK. Stem cells: a revolution in therapeutics-recent advances in stem cell biology and their therapeutic applications in regenerative medicine and cancer therapies. Clin Pharmacol Ther 2007;82:252-64. (Pubitemid 47260547)
4. Mimeault M, Batra SK. Concise review: recent advances on the significance of stem cells in tissue regeneration and cancer therapies. Stem Cells 2006;24:2319-45. (Pubitemid 44679695)
5. Horton R, Millman J, Colton C et al. Engineering microenvironments for embryonic stem cell differentiation to cardiomyocytes. Regen Med 2009;4:721-32.
6. Thomson H. Bioprocessing of embryonic stem cells for drug discovery. Trends Biotechnol 2007;25:224-30. (Pubitemid 46591928)
7. McDevitt T, Palecek S. Innovation in the culture and derivation of pluripotent human stem cells. Curr Opin Biotechnol 2008;19:527-33.
8. Lee H, Park J, Forget B et al. Induced pluripotent stem cell in regenerative medicine: an argument for continued research on human embryonic stem cells. Regen Med 2009;4:759-69.
9. Couture LA. Scalable pluripotent stem cell culture. Nat Biotechnol 2010;28:562-63.
10. Geron hESC-derived Oligodendrocytes GRNOPC1. http://www.geron.com/ products/productinformation/spinalcordinjury.aspx.
11. Advanced cell technology hESC-derived RPE cells for treatment of AMD. http://www. actcblog.com/2011/01/act-receives-fda-clearance-for-clinical-trials- using-escs-to-treat-amdafflicts-10-15-million-americans.html.
12. European Union Regulation (EC) No 1394/2007 of the European Parliament and of the council of 13 November 2007 on advanced therapy medicinal products and amending directive 2001/83/EC and regulation (EC) No 726/2004. Official Journal of the European Union 2007, L324/121-L324/137.
13. Burger SR. Current regulatory issues in cell and tissue therapy. Cytotherapy 2003;5:289-98. (Pubitemid 37264995)
14. Halme DG, Kessler DA. FDA regulation of stem-cell-based therapies. N Engl J Med 2006;355:1730-35. (Pubitemid 44583964)
15. Preti RA. Bringing safe and effective cell therapies to the bedside. Nat Biotechnol 2005;23:801-4. (Pubitemid 43093117)
16. Kirouac D, Zandstra P. The systematic production of cells for cell therapies. Cell Stem Cell 2008;3:369-81.
17. Du Moulin GC, Morohashi M. Development of a regulatory strategy for the cellular therapies: an American perspective. Mater Sci Eng C-Biomim Supramolec Syst 2000;13:15-17.
18. ReNeuron ReN001. http://www.reneuron.com/news-events/news/document-269- 237.php.
19. Mason C, Hoare M. Regenerative medicine bioprocessing: building a conceptual framework based on early studies. Tissue Eng 2007;13:301-11.
20. Mason C, Hoare M. Regenerative medicine bioprocessing: the need to learn from the experience of other fields. Regen Med 2006;1:615-23.
21. Rowley JA. Developing cell therapy biomanufacturing processes. Chem Eng Prog 2010;106:50-5.
22. Hellman KB, Nerem RM. Advancing tissue engineering and regenerative medicine. Tissue Eng 2007;13:2823-24. (Pubitemid 350233089)
23. Thomas RJ, Hourd P, Williams DJ. Application of process quality engineering techniques to improve the understanding of the in vitro processing of stem cells for therapeutic use. J Biotechnol 2008;136:148-55.
24. Abu-Absi SF, Yang L, Thompson P et al. Defining process design space for monoclonal antibody cell culture. Biotechnol Bioeng 2010;106:894-905.
25. Placzek M, Chung I, Macedo H et al. Stem cell bioprocessing: fundamentals and principles. J R Soc Interface 2009;6:209-32.
26. Human tissue authority codes of practise. http://www.hta.gov.uk/ legislationpoliciesand codesofpractice/codesofpractice.cfm.
27. Ljungqvist B, Reinmü ller B. People as a contamination source: cleanroom clothing after 1, 25, and 50 washings/sterilizing cycles. Eur J Paren Pharm Sci 2003;8:75-80.
28. Rayment E, Williams DJ. Concise review: mind the gap: challenges in characterizing and quantifying cell-and tissue-based therapies for clinical translation. Stem Cells 2010;28:996-1004.
29. Azari S, Ahmadi N, Tehrani MJ et al. Profiling and authentication of human cell lines using short tandem repeat (STR) loci: report from the national cell bank of Iran. Biologicals 2007;35:195-202. (Pubitemid 46901036)
30. Martin P. The emerging industry. In: Williams DJ, Archer R, Dent A (eds). Building a Viable Regenerative Medicine Industry-A Guide for Stakeholders. Loughborough University Design and Print Services Loughborough, UK, 2010,13-20.
31. Ginty P. Regulation. In: Williams DJ, Archer R, Dent A (eds). Building a Viable Regenerative Medicine Industry-A Guide for Stakeholders. Loughborough University Design and Print Services Loughborough, UK, 2010,39-45.
32. European Agency for the Evaluation of Medicinal Products. Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products. London: European Agency for the Evaluation of Medicinal Products, 2004.
33. Sundin M, Ringden O, Sundberg B et al. No alloantibodies against mesenchymal stromal cells, but presence of anti-fetal calf serum antibodies, after transplantation in allogeneic hematopoietic stem cell recipients. Haematologica 2007;92:1208-15. (Pubitemid 350144179)
34. Bendle G, Linnemann C, Hooijkaas A et al. Lethal graft-versus-host disease in mouse models of T cell receptor gene therapy. Nat Med 2010;16:565-70.
35. Schriebl K, Lim S, Choo A et al. Stem cell separation; a bottleneck in stem cell therapy. Biotechnol J 2010;5:50-61.
36. Yang H, Zhang Y, Liu Z et al. Mouse embryonic stem cell-derived cardiomyocytes express functional adrenoceptors. Biochem Biophys Res Commun 2008;368:887-92.
37. Lim M, Ye H, Panoskaltsis N et al. Intelligent bioprocessing for haemotopoietic cell cultures using monitoring and design of experiments. Biotechnol Adv 2007;25:353-68. (Pubitemid 46783374)
38. Berridge MV, Tan AS. Characterization of the cellular reduction of 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT): subcellular localization, substrate dependence, and involvement of mitochondrial electron transport in Mtt reduction. Arch Biochem Biophys 1993;303:474-82. (Pubitemid 23199849)
39. Baust JG. Concepts in biopreservation. In: Baust JG, Baust JM (eds). Advances in Biopreservation. New York: CRC Press-Taylor and Francis Publishing, 2006.
40. Archer R, Williams DJ. Why tissue engineering needs process engineering. Nat Biotechnol 2005;23:1353-55. (Pubitemid 41679381)
41. Terstegge S, Laufenberg I, Pochert J. Automated maintenance of embryonic stem cell cultures. Biotechnol Bioeng 2007;96:195-201. (Pubitemid 46036171)
42. Thomas RJ, Hope AD, Hourd P et al. Automated, serum-free production of CTX0E03: a therapeutic clinical grade human neural stem cell line. Biotechnol Lett 2009;31:1167-72.
43. Kino-Oka M, Ogawa N, Umegaki R et al. Bioreactor design for successive culture of anchorage-dependent cells operated in an automated manner. Tissue Eng 2005;11:535-45. (Pubitemid 40632569)
44. Brinkmann M, Lü tkemeyer D, Gudermann F et al. New technologies for automated cell counting based on optical image analysis 'The Cellscreen'. Cytotechnology 2002;38:119-27.
45. Archer R, Wood L. Animal Cell Technology: Developments, Processes, and Products. Butterworth Heinemann Oxford, UK, 1992,403-8.
46. Thomas RJ, Chandra A, Liu Y et al. Manufacture of a human mesenchymal stem cell population using an automated cell culture platform. Cytotechnology 2007;55:31-9. (Pubitemid 47622172)
47. Thomas RJ, Anderson D, Chandra A et al. Automated, scalable culture of human embryonic stem cells in feeder-free conditions. Biotechnol Bioeng 2009;102:1636-44.
48. Liu Y, Hourd P, Chandra A et al. Human cell culture process capability: a comparison of manual and automated production. J Tissue Eng Regen Med 2010;4:45-54.
49. Stamatis DH. Six Sigma Fundamentals: A Complete Guide to the System, Methods, and Tools. New York, NY: Productivity Press, 2004.
50. Fisher RA. The Design of Experiments, 9th edn. Macmillan New York, USA, 1971.
51. Poon GK, Chan JS, Williams DJ. Experimental study of workpiece-level variability in blindvia electroplating. Proc Inst Mech Eng 2001;215(B):521-30. (Pubitemid 33773208)
52. Zandstra PW, Petzer AL, Eaves CJ et al. Cellular determinants affecting the rate of cytokine depletion in cultures of human hematopoietic cells. Biotechnol Bioeng 1997;54:58-66. (Pubitemid 27142533)
53. Yao CL, Liu CH, Chu IM et al. Factorial designs combined with the steepest ascent method to optimize serum-free media for ex vivo expansion of human haematopoietic stem cells. Enzyme Microb Technol 2003;33:343-52.
54. Cortin V, Garnier A, Pineault N et al. Efficient in vitro megakaryocyte maturation using cytokine cocktails optimized by statistical experimental design. Exp Hematol 2005;33:1182-91. (Pubitemid 41416966)