Bioreactor design and bioprocess controls for industrialized cell processing: Bioengineering strategies and platform technologies

BioProcess International

Volumn 10, Issue 6, 2012, Pages 22-33

  Hambor, John E ^a  

^a Cell Therapy Group   (United States)

Author keywords

Automation; Cell culture; Disposables; Formulation; Scale up

Indexed keywords

ALLOTRANSPLANTATION; BIOPROCESS; BIOREACTOR DESIGN; CANCER THERAPY; CARCINOGENICITY; CELL AGGREGATION; CELL CULTURE; CELL DENSITY; CELL DIFFERENTIATION; CELL DIVISION; CELL THERAPY; EMBRYONIC STEM CELL; FOOD AND DRUG ADMINISTRATION; GOOD MANUFACTURING PRACTICE; MICROBIAL CONTAMINATION; REVIEW; STEM CELL EXPANSION;

EID: 84863456855     PISSN: 15426319     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Review

References (77)

1. Mason C, Manzotti E. Regenerative Medicine Cell Therapies: Numbers of Units Manufactured and Patients Treated Between 1988 and 2010. Regen. Med. 5, 2010: 307-313.
2. Li F, et al. Cell Culture Processes for Monoclonal Antibody Production. MAbs 2, 2010: 466-479.
3. Kirouac DC, Zandstra PW. The Systematic Production of Cells for Cell Therapies. Cell Stem Cell 3, 2008: 369-381.
4. Thomson JA, et al. Embryonic Stem Cell Lines Derived from Human Blastocysts. Science 28, 1998: 1145-1147. (Pubitemid 28516247)
5. Hay DC, et al. Direct Differentiation of Human Embryonic Stem Cells to Hepatocyte-Like Cells Exhibiting Functional Activities. Cloning Stem Cells 9, 2007: 51-62. (Pubitemid 46642071)
6. Kroon E, et al. Pancreatic Endoderm Derived from Human Embryonic Stem Cells Generates Glucose-Responsive Insulin-Secreting Cells In Vivo. Nat. Biotechnol. 26, 2008: 443-452. (Pubitemid 351501814)
7. Mummery C, et al. Differentiation of Human Embryonic Stem Cells to Cardiomyocytes: Role of Coculture with Visceral Endoderm-Like Cells. Circulation 107, 2003: 2733-2740.
8. Toh WS, et al. Differentiation and Enrichment of Expandable Chondrogenic Cells from Human Embryonic Stem Cells In Vitro. J. Cell Mol. Med. 13, 2009: 3570-3590.
9. Zhang SC, et al. In Vitro Differentiation of Transplantable Neural Precursors from Human Embryonic Stem Cells. Nat. Biotechnol. 19, 2001: 1129-1133.
10. Lanza R, et al. Handbook of Stem Cells, Volume 2: Adult and Fetal Stem Cells. Elsevier Academic Press, Boston, MA, 2004.
11. Takahashi K, et al. Induction of Pluripotent Stem Cells from Adult Human Fibroblasts By Defined Factors. Cell 131, 2007: 861-872. (Pubitemid 350138099)
12. Takahashi K, Yamanaka S. Induction of Pluripotent Stem Cells from Mouse Embryonic and Adult Fibroblast Cultures By Defined Factors. Cell 126, 2006: 663-676. (Pubitemid 44233629)
13. Yu J, et al. Induced Pluripotent Stem Cell Lines Derived from Human Somatic Cells. Science 318, 2007: 1917-1920.
14. Selvaraj V, et al. Switching Cell Fate: The Remarkable Rise of Induced Pluripotent Stem Cells and Lineage Reprogramming Technologies. Trends Biotechnol. 28, 2010: 214-223.
15. Jang S, et al. Functional Neural Differentiation of Human Adipose Tissue-Derived Stem Cells Using bFGF and Forskolin. BMC Cell Biol. 11, 2010: 25.
16. Vierbuchen T, et al. Direct Conversion of Fibroblasts to Functional Neurons By Defined Factors. Nature 463, 2010: 1035-1041.
17. Zhu XQ, et al. Transient In Vitro Epigenetic Reprogramming of Skin Fibroblasts into Multipotent Cells. Biomaterials 31, 2010: 2779-2787.
18. Placzek MR, et al. Stem Cell Bioprocessing: Fundamentals and Principles. J. Roy. Soc. Interface 6, 2009: 209-232.
19. Niebruegge S, et al. Generation of Human Embryonic Stem Cell-Derived Mesoderm and Cardiac Cells Using Size-Specified Aggregates in an Oxygen-Controlled Bioreactor. Biotechnol. Bioeng. 102, 2009: 493-507.
20. Serra M, et al. Integrating Human Stem Cell Expansion and Neuronal Differentiation in Bioreactors. BMC Biotechnol. 9, 2009: 82.
21. Serra M, et al. Stirred Bioreactors for the Expansion of Adult Pancreatic Stem Cells. Ann. Anat. 191, 2009: 104-115.
22. Gerlach JC, et al. Interwoven Four-Compartment Capillary Membrane Technology for Three-Dimensional Perfusion with Decentralized Mass Exchange to Scale Up Embryonic Stem Cell Culture. Cells Tiss. Org. 192, 2010: 39-49.
23. Come J, et al. Improvement of Culture Conditions of Human Embryoid Bodies Using a Controlled Perfused and Dialyzed Bioreactor System. Tiss. Eng. C Meth. 14, 2008: 289-298.
24. Gerecht-Nir S, Cohen S, Itskovitz-Eldor J. Bioreactor Cultivation Enhances the Efficiency of Human Embryoid Body (hEB) Formation and Differentiation. Biotechnol. Bioeng. 86, 2004: 493-502. (Pubitemid 38679767)
25. King JA, Miller WM. Bioreactor Development for Stem Cell Expansion and Controlled Differentiation. Curr. Opin. Chem. Biol. 11, 2007: 394-398. (Pubitemid 47302847)
26. Azarin SM, Palecek SP. Development of Scalable Culture Systems for Human Embryonic Stem Cells. Biochem. Eng. J. 48, 2010: 378.
27. Cimetta E, et al. Micro-Bioreactor Arrays for Controlling Cellular Environments: Design Principles for Human Embryonic Stem Cell Applications. Methods 47, 2009: 81-89.
28. Fong WJ, et al. Perfusion Cultures of Human Embryonic Stem Cells. Bioprocess Biosyst. Eng. 27, 2005: 381-387. (Pubitemid 41703282)
29. Gerlach JC, et al. Dynamic 3D Culture Promotes Spontaneous Embryonic Stem Cell Differentiation In Vitro. Tiss. Eng. C Meth. 16, 2010: 115-121.
30. Gottwald E, et al. Chip-Based Three-Dimensional Cell Culture in Perfused Micro-Bioreactors. J. Vis. Exp. 15, 2008.
31. Zhao F, et al. Perfusion Affects the Tissue Developmental Patterns of Human Mesenchymal Stem Cells in 3D Scaffolds. J. Cell Physiol. 219, 2009: 421-429.
32. Zhao F, Ma T. Perfusion Bioreactor System for Human Mesenchymal Stem Cell Tissue Engineering: Dynamic Cell Seeding and Construct Development. Biotechnol. Bioeng. 91, 2005: 482-493. (Pubitemid 41099034)
33. Cukierman E, Pankov R, Yamada KM. Cell Interactions with Three-Dimensional Matrices. Curr. Opin. Cell Biol. 14, 2002: 633-639. (Pubitemid 35247748)
34. Lund AW, et al. The Natural and Engineered 3D Microenvironment As a Regulatory Cue During Stem Cell Fate Determination. Tiss. Eng. B Rev. 15, 2009: 371-380.
35. Pampaloni F, Reynaud EG, Stelzer EH. The Third Dimension Bridges the Gap Between Cell Culture and Live Tissue. Nat. Rev. Mol. Cell Biol. 8, 2007: 839-845. (Pubitemid 47462131)
36. Dean SK, et al. Differentiation of Encapsulated Embryonic Stem Cells After Transplantation. Transplantation 82, 2006: 1175-1184. (Pubitemid 44748020)
37. Maguire T, et al. Control of Hepatic Differentiation via Cellular Aggregation in an Alginate Microenvironment. Biotechnol. Bioeng. 98, 2007: 631-644. (Pubitemid 47556131)
38. Maguire T, et al. Alginate-PLL Microencapsulation: Effect on the Differentiation of Embryonic Stem Cells into Hepatocytes. Biotechnol. Bioeng. 93, 2006: 581-591. (Pubitemid 43232184)
39. Murua A, et al. Cell Microencapsulation Technology: Towards Clinical Application. J. Contr. Rel. 132, 2008: 76-83.
40. Wang N, et al. Alginate Encapsulation Technology Supports Embryonic Stem Cells Differentiation into Insulin-Producing Cells. J. Biotechnol. 144, 2009: 304-312.
41. Xing Q, et al. Porous Biocompatible Three-Dimensional Scaffolds of Cellulose Microfiber/Gelatin Composites for Cell Culture. Acta. Biomater. 6, 2009: 2132-2139.
42. Dang SM, et al. Controlled, Scalable Embryonic Stem Cell Differentiation Culture. Stem Cells 22, 2004: 275-282. (Pubitemid 38736612)
43. Itskovitz-Eldor J, et al. Differentiation of Human Embryonic Stem Cells into Embryoid Bodies Compromising the Three Embryonic Germ Layers. Mol. Med. 6, 2000: 88-95.
44. Keller GM. In Vitro Differentiation of Embryonic Stem Cells. Curr. Opin. Cell Biol. 7, 1995: 862-869.
45. Serra M, et al. Novel Culture Strategy for Human Stem Cell Proliferation and Neuronal Differentiation. J. Neurosc. Res. 85, 2007: 3557-3566. (Pubitemid 350228701)
46. Amit M, et al. Suspension Culture of Undifferentiated Human Embryonic and Induced Pluripotent Stem Cells. Stem Cell Rev. 6, 2010: 248-259.
47. Krawetz R, et al. Large-Scale Expansion of Pluripotent Human Embryonic Stem Cells in Stirred Suspension Bioreactors. Tiss. Eng. C Meth. 16(4) 2010: 573-582.
48. Singh H, et al. Up-Scaling Single Cell-Inoculated Suspension Culture of Human Embryonic Stem Cells. Stem Cell Res. 4, 2010: 165-179.
49. Steiner D, et al. Derivation, Propagation and Controlled Differentiation of Human Embryonic Stem Cells in Suspension. Nat. Biotechnol. 28, 2010: 361-364.
50. Baghbaderani BA, et al. Expansion of Human Neural Precursor Cells in Large-Scale Bioreactors for the Treatment of Neurodegenerative Disorders. Biotechnol. Prog. 24, 2008: 859-870.
51. Baghbaderani BA, et al. Bioreactor Expansion of Human Neural Precursor Cells in Serum-Free Media Retains Neurogenic Potential. Biotechnol. Bioeng. 105, 2010: 823-833.
52. Chawla M, et al. Production of Islet-Like Structures from Neonatal Porcine Pancreatic Tissue in Suspension Bioreactors. Biotechnol. Prog. 22, 2006: 561-567.
53. Akasha AA, et al. Entrapment of Embryonic Stem Cells-Derived Cardiomyocytes in Macroporous Biodegradable Microspheres: Preparation and Characterization. Cell Physiol. Biochem. 22, 2008: 665-672.
54. Fernandes AM, et al. Mouse Embryonic Stem Cell Expansion in a Microcarrier-Based Stirred Culture System. J. Biotechnol. 132, 2007: 227-236.
55. Eibes G, et al. Maximizing the Ex Vivo Expansion of Human Mesenchymal Stem Cells Using a Microcarrier-Based Stirred Culture System. J. Biotechnol. 146, 2010: 194-197.
56. Sart S, Schneider YJ, Agathos SN. Ear Mesenchymal Stem Cells: An Efficient Adult Multipotent Cell Population Fit for Rapid and Scalable Expansion. J. Biotechnol. 139, 2009: 291-299.
57. Lock LT, Tzanakakis ES. Expansion and Differentiation of Human Embryonic Stem Cells to Endoderm Progeny in a Microcarrier Stirred-Suspension Culture. Tiss. Eng. A 15, 2009: 2051-2063.
58. Nie Y, et al. Scalable Culture and Cryopreservation of Human Embryonic Stem Cells on Microcarriers. Biotechnol. Prog. 25, 2009: 20-31.
59. Oh SK, et al. Long-Term Microcarrier Suspension Cultures of Human Embryonic Stem Cells. Stem Cell Res. 2, 2009: 219-230.
60. Phillips BW, et al. Attachment and Growth of Human Embryonic Stem Cells on Microcarriers. J. Biotechnol. 138, 2008: 24-32.
61. Serra M, et al. Improving Expansion of Pluripotent Human Embryonic Stem Cells in Perfused Bioreactors Through Oxygen Control. J. Biotechnol. 148, 2010: 208-215.
62. Bauwens C, et al. Development of a Perfusion Fed Bioreactor for Embryonic Stem Cell-Derived Cardiomyocyte Generation: Oxygen-Mediated Enhancement of Cardiomyocyte Output. Biotechnol. Bioeng. 90, 2005: 452-461. (Pubitemid 40779195)
63. Lee SH, et al. Human Beta-Cell Precursors Mature into Functional Insulin-Producing Cells in an Immunoisolation Device: Implications for Diabetes Cell Therapies. Transplantation 87, 2009: 983-991.
64. Goldstein AS, et al. Effect of Convection on Osteoblastic Cell Growth and Function in Biodegradable Polymer Foam Scaffolds. Biomaterials 22, 2001: 1279-1288. (Pubitemid 32409949)
65. Kuo CK, et al. Cartilage Tissue Engineering: Its Potential and Uses. Curr. Opin. Rheumatol. 18, 2006: 64-73. (Pubitemid 43740407)
66. Liu H, Roy K. Biomimetic Three- Dimensional Cultures Significantly Increase Hematopoietic Differentiation Efficacy of Embryonic Stem Cells. Tissue Eng. 11, 2005: 319-330. (Pubitemid 40515199)
67. Delcroix GJ, et al. Adult Cell Therapy for Brain Neuronal Damages and the Role of Tissue Engineering. Biomaterials 31, 2010: 2105-2120.
68. Nieponice A, et al. Development of a Tissue-Engineered Vascular Graft Combining a Biodegradable Scaffold, Muscle-Derived Stem Cells and a Rotational Vacuum Seeding Technique. Biomaterials 29, 2008: 825-833. (Pubitemid 350266044)
69. Xie L, Wang DI. Fed-Batch Cultivation of Animal Cells Using Different Medium Design Concepts and Feeding Strategies. Biotechnol. Bioeng. 43, 1994: 1175-1189. (Pubitemid 24162416)
70. Stolzing A, Scutt A. Effect of Reduced Culture Temperature on Antioxidant Defences of Mesenchymal Stem Cells. Free Radic. Biol. Med. 41, 2006: 326-338. (Pubitemid 43928506)
71. Proulx C, et al. Increased Megakaryopoiesis in Cultures of CD34-Enriched Cord Blood Cells Maintained at 39 Degrees C. Biotechnol. Bioeng. 88, 2004: 675-680. (Pubitemid 40775323)
72. McAdams TA, Miller WM, Papoutsakis ET. pH is a Potent Modulator of Erythroid Differentiation. Br. J. Haematol. 103, 1998: 317-325. (Pubitemid 28522434)
73. Yang H, Miller WM, Papoutsakis ET. Higher pH Promotes Megakaryocytic Maturation and Apoptosis. Stem Cells 20, 2002: 320-328. (Pubitemid 34765091)
74. Fischer B, Bavister BD. Oxygen Tension in the Oviduct and Uterus of Rhesus Monkeys, Hamsters and Rabbits. J. Reprod. Fertil. 99, 1993: 673-679. (Pubitemid 24052018)
75. Ottosen LD, et al. Observations on Intrauterine Oxygen Tension Measured By Fibre-Optic Microsensors. Reprod. Biomed. Online 13, 2006: 380-385. (Pubitemid 44375417)
76. Ezashi T, Das P, Roberts RM. Low O2 Tensions and the Prevention of Differentiation of hES Cells. Proc. Nat. Acad. Sci. USA 102, 2005: 4783-4788. (Pubitemid 40471531)
77. Prasad SM, et al. Continuous Hypoxic Culturing Maintains Activation of Notch and Allows Long-Term Propagation of Human Embryonic Stem Cells Without Spontaneous Differentiation. Cell Prolif. 42, 2009: 63-74.