Points to consider in the development of seed stocks of pluripotent stem cells for clinical applications: International Stem Cell Banking Initiative (ISCBI)

Regenerative Medicine

Volumn 10, Issue , 2015, Pages 1-44

  Andrews, P W ^a   Baker, D ^a   Benvinisty, N ^b   Miranda, B ^c   Bruce, K ^d   Brustle O ^e   Choi, M ^f   Choi, Y M ^g   Crook, J M ^h   De Sousa, P A ⁱ   Dvorak, P ^j   Freund, C ^k   Firpo, M ^l   Furue, M K ^m   Gokhale, P ^a   Ha, H Y ⁿ   Han, E ^f   Haupt, S ^o   Healy, L ^p   Hei, D J ^q   Hovatta, O ^r   Hunt, C ^p   Hwang, S M ^s   Inamdar, M S ^t   Isasi, R M ^u   Jaconi, M ^v   Jekerle, V ^w   Kamthorn, P ^x   Kibbey, M C ^y   Knezevic, I ^z   Knowles, B B ^aa,aw   Koo, S K ⁿ   Laabi, Y ^ab   Leopoldo, L ^ac   Liu, P ^ad   Lomax, G P ^ae   Loring, J F ^af   Ludwig, T E ^ag   Montgomery, K ^ag   Mummery, C ^k   Nagy, A ^ah   Nakamura, Y ^ai   Nakatsuji, N ^aj   Oh, S ^ak   Oh, S K ^g   Otonkoski, T ^al   Pera, M ^h   Peschanski, M ^ab   Pranke, P ^am   Rajala, K M ^an   Rao, M ^ao   Ruttachuk, R ^x   Reubinoff, B ^ap   Ricco, L ^ac   Rooke, H ^aq   Sipp, D ^ar   Stacey, G N ^p   Suemori, H ^as   Takahashi, T A ^as   Takada, K ^as   Talib, S ^ae   Tannenbaum, S ^ap   Yuan, B Z ^at   Zeng, F ^au   Zhou, Q ^av   more..

^a UNIVERSITY OF SHEFFIELD   (United Kingdom)

^b HEBREW UNIVERSITY OF JERUSALEM   (Israel)

^c Biobank Andalousian Public Health System   (Spain)

^d Roslin Cells Limited   (United Kingdom)

^e UNIVERSITY OF BONN   (Germany)

^f Ministry of Food and Drugs Safety (MFDS) (KFDA)   (South Korea)

^g Seoul National University   (South Korea)

^h UNIVERSITY OF MELBOURNE   (Australia)

ⁱ UNIVERSITY OF EDINBURGH   (United Kingdom)

^j MASARYK UNIVERSITY   (Czech Republic)

^k LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

^l UNIVERSITY OF MINNESOTA MEDICAL SCHOOL   (United States)

^m NATIONAL INSTITUTE OF BIOMEDICAL INNOVATION   (Japan)

ⁿ Korea National Institute of Health   (South Korea)

^o Strategy and Mktg Consultants GmbH   (Germany)

^p NATIONAL INSTITUTE FOR BIOLOGICAL STANDARDS AND CONTROL   (United Kingdom)

^q UNIVERSITY OF WISCONSIN MADISON   (United States)

^r KAROLINSKA INSTITUTE   (Sweden)

^s Bioresource Collection and Research Center   (Taiwan)

^t JAWAHARLAL NEHRU CENTRE FOR ADVANCED SCIENTIFIC RESEARCH   (India)

^u MCGILL UNIVERSITY   (Canada)

^v UNIVERSITY OF GENEVA   (Switzerland)

^w EUROPEAN MEDICINES AGENCY   (United Kingdom)

^x CHULALONGKORN UNIVERSITY   (Thailand)

^y United States Pharmacopeia   (United States)

^z WORLD HEALTH ORGANIZATION   (Switzerland)

^aa JACKSON LABORATORY   (United States)

^ab INSERM   (France)

^ac Andalousian Initiative Advanced Therapies (IATA)   (Spain)

^ad WELLCOME TRUST SANGER INSTITUTE   (United Kingdom)

^ae California Institute for Regenerative Medicine   (United States)

^af SCRIPPS RESEARCH INSTITUTE   (United States)

^ag WiCell Research Institute   (United States)

^ah MOUNT SINAI HOSPITAL   (Canada)

^ai RIKEN BIORESOURCE CENTER   (Japan)

^aj KYOTO UNIVERSITY   (Japan)

^ak AGENCY FOR SCIENCE   (Singapore)

^al UNIVERSITY OF HELSINKI   (Finland)

^am FEDERAL UNIVERSITY OF RIO GRANDE DO SUL   (Brazil)

^an TAMPERE UNIVERSITY OF TECHNOLOGY   (Finland)

^ao New York Stem Cell Foundation   (United States)

^ap HADASSAH HEBREW UNIVERSITY MEDICAL CENTER   (Israel)

^aq International Society for Stem Cell Research   (United States)

^ar RIKEN Center for Biosystems Dynamics Research   (Japan)

^as KYOTO UNIVERSITY   (Japan)

^at NATIONAL INSTITUTES FOR FOOD AND DRUG CONTROL   (China)

^au SHANGHAI JIAO TONG UNIVERSITY SCHOOL OF MEDICINE   (China)

^av INSTITUTE OF ZOOLOGY   (China)

^aw MAHIDOL UNIVERSITY   (Thailand)

more..

Author keywords

[No Author keywords available]

Indexed keywords

CRYOPROTECTIVE AGENT;

ALLOGENEIC STEM CELL TRANSPLANTATION; ANTIGEN EXPRESSION; ARTICLE; CELL LABELING; CONSENSUS DEVELOPMENT; CRYOPRESERVATION; DONOR SELECTION; GENETIC DISORDER; GENETIC SCREENING; GENETIC STABILITY; HEALTH CARE ORGANIZATION; HEALTH CARE POLICY; HUMAN; INFORMED CONSENT; LEGAL ASPECT; MEDICAL AUDIT; MEDICAL HISTORY; MEDICAL INFORMATION; MEDICAL RECORD; MICROBIOLOGICAL EXAMINATION; PLURIPOTENT STEM CELL LINE; PRACTICE GUIDELINE; PRIORITY JOURNAL; PROFESSIONAL STANDARD; QUALITY CONTROL; REIMBURSEMENT; RESEARCH ETHICS; CARCINOGEN TESTING; CELL LINE; DONOR; ETHICS; GENOMIC INSTABILITY; HEALTH CARE FACILITY; INTERNATIONAL COOPERATION; PLURIPOTENT STEM CELL; PROCEDURES; RISK ASSESSMENT; SAFETY; TISSUE PRESERVATION;

BIOLOGICAL SPECIMEN BANKS; CARCINOGENICITY TESTS; CELL LINE; GENOMIC INSTABILITY; HUMANS; INTERNATIONAL COOPERATION; PLURIPOTENT STEM CELLS; PRACTICE GUIDELINES AS TOPIC; RISK ASSESSMENT; SAFETY; TISSUE DONORS; TISSUE PRESERVATION;

EID: 84923189564     PISSN: 17460751     EISSN: 1746076X     Source Type: Journal    
DOI: 10.2217/rme.14.93     Document Type: Article

References (113)

1. ISCBI. International Stem Cell Initiative. Andrews P, Arias-Diaz J, Auerbach J et al. Consensus guidance for banking and supply of human embryonic stem cell lines for research purposes. Stem Cell Reviews and Reports 2009, 5, 301-314 (2009).
2. PAS 84. Cell Therapy and Regenerative Medicine Glossary. Regenerative Medicine 7(3, Suppl. 1) (2012). http://shop.bsigroup.com/Browse-by-Sector/Healthcare/PAS-84
3. World Health Organization. Recommendations for the evaluation of animal cell cultures as substrates for the manufacture of biological medicinal products and for the characterization of cell banks .WHO Technical Report Series 978, Annex 3 (2010). Replacement of WHO Technical Report Series, No. 878, Annex 1. www.who.int/biologicals/vaccines/TRS-978-Annex-3.pdf
4. Isasi R, Knoppers B. Monetary payments for the procurement of oocytes for stem cell research: in search of ethical and political consistency. Stem Cell Research 1, 37-44 (2007).
5. Isasi R, Knoppers B, Andrews P et al. International Stem Cell Forum Ethics Working Party. Disclosure and Management of Research Findings in Stem Cell Research and Banking: Policy Statement by the ISCF-EWP. Regen. Med. 7(3), 439-448 (2012).
6. ISSCR (2006). International Society for Stem Cell Research (ISSCR) Guidelines for the Conduct of Human Embryonic Stem Cell Research (December 2006). Dickens BM. Med Law 27(1), 179-190 (2008).
7. ISCFEWP. International Stem Cell Forum Ethics Working Party. Knoppers BM, Andrews PW, Bredenoord A et al. Ethics issues in stem cell research. Science 312(5772), 366-367 (2006).
8. Murdoch A, Braude P, Stacey G et al. The Procurement Working Group of the National Clinical hESC Forum. The Procurement of cells for the derivation of human embryonic stem cell lines for therapeutic use: recommendations for good practice. Stem Cell Rev. Reports 8 (1), 91-99 (2011).
9. Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO). Donation of starting material for cell-based advanced therapies: a SaBTO review, Department of Health, UK (2014).
10. Gymrek M, McGuire AL, Golan D, Halperin E, Erlich Y. Identifying personal genomes by surname inference. Science 339(6117), 321-324 (2013).
11. Isasi R, Andrews P, Baltz J et al. Identifiability and privacy in pluripotent stem cell research. Cell Stem Cell 14(4), 427-30 (2014).
12. Lomax G, Hull S, Lowenthal J, Rao M, Isasi R. The DISCUSS Project: induced pluripotent stem cell lines from previously collected research biospecimens and informed consent: points to consider. Stem Cells Trans. Med. 2(10) (2013)
13. ICH Q5D Derivation and Characterization of cell substrates used for production of biotechnological/biological products (1997). www.ich.org/products/guidelines/quality/quality-single/article/derivation-and-characterisation-of-cell-substrates-used-for-production-of-biotechnologicalbiologica.html
14. Malone JH, Oliver B. Microarrays, deep sequencing and the true measure of the transcriptome. BMC Biol. 9, 34 (2011).
15. Lui L, Li Y, Li S et al. Comparison of next generation sequencing systems.J. Biomed. Biotechnol. 251364 (2012).
16. Frese K, Katus, H, Meder B. Next-generation sequencing: from understanding biology to personalized medicine. Biology 2, 378-398 (2013).
17. Victoria J, Wang C, Jones M et al. Viral nucleic acids in live-attenuated vaccines: detection of minority variants and an adventitious virus. J. Virol. 84(12), 6033-40 (2010).
18. Gilliland S, Forrest L, Carre H et al. Investigation of porcine circovirus contamination in human vaccines. Biologicals 40(4), 270-277 (2012).
19. World Health Organisation. Community genetics services: report of a WHO consultation on community genetics in low- and middle-income countries. (2011).
20. Brazma A. On the importance of standardization in life sciences. Bioinformatics 17(2), 113-114 (2001).
21. World Health Organization. WHO Guidelines on Tissue Infectivity Distribution in Transmissible Spongiform Encephalopathies. WHO, Geneva (2010). www.who.int/bloodproducts/tablestissueinfectivity.pdf
22. EMA. CHMP/CAT position statement on Creutzfeldt-Jakob disease and advanced therapy medicinal products. Committee for Medicinal Products for Human Use (CHMP) and Committee for Advanced Therapies (CAT). London, UK (2011).
23. EMA. Note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products (EMA/410/01 rev.3). Official Journal of The European Union. (2011). 2011/C 73/01.
24. Young L, Sung J, Stacey G, Masters J. Detection of mycoplasma in cell cultures. Nat. Protoc. 5(5), 929-934 (2010).
25. Volokhov D, Graham L, Brorson K, Chizhikov V. Mycoplasma testing of cell substrates and biologics: review of alternative non-microbiological techniques. Mol. Cell Probes. 25(2-3), 69-77 (2011).
26. Martins-Taylor K, Xu R-H. Concise review: genomic stability of human induced pluripotent stem cells. Stem Cells 30, 22-27 (2012).
27. Nguyen H, Geens M, Spits C. Genetic and epigenetic instability in human pluripotent stem cells. Human Reproduction Update 19, 187-205 (2013).
28. Ben-David U, Arad G, Weissbein U et al. Aneuploidy induces profound changes in gene expression, proliferation and tumorigenicity of human pluripotent stem cells. Nat. Commun. 5, 4825 (2014).
29. Lund J, Emani M, Barbaric I et al. Karyotypically abnormal ESCs are sensitive to HDAC inhibitors and show altered regulation of genes linked to cancers and neurological diseases. Stem Cell Res. 11, 1022-1036 (2013).
30. Sun Y, Yang Y, Zeng S, Tan Y, Lu G, Lin G. Identification of proteins related to epigenetic regulation in the malignant transformation of aberrant karyotypic human embryonic stem cells by quantitative proteomics. PLoS One 2014, 9, e85823.
31. Chen Z, Zhao T, Xu Y. The genomic stability of induced pluripotent stem cells. Protein Cell 3(4), 271-277 (2012).
32. Hyka-Nouspikel N, Desmarais J, Gokhale PJ et al. Deficient DNA damage response and cell cycle checkpoints lead to accumulation of point mutations in human embryonic stem cells. Stem Cells 30(9), 1901-1910 (2012).
33. ISCI. International Stem Cell Initiative. Amps K, Andrews P, Anyfantis G et al. Screening ethnically diverse human embryonic stem cells identifies a chromosome 20 minimal amplicon conferring growth advantage. Nat. Biotechnol. 29(12), 1132-1144 (2011).
34. Laurent LC, Ulitsky I, Slavin I et al. Dynamic changes in the copy number of pluripotency and cell proliferation genes in human ESCs and hiPSCs during reprogramming and time in culture. Cell Stem Cell 8(1), 106-118 (2011).
35. Steinemann D, Göhring G, Schlegelberger B. Genetic instability of modified stem cells - a first step towards malignant transformation? Am. J. Stem Cells 2(1),39-51 (2013).
36. Yang S, Lin G, Tan Y, Deng L, Yuan D, Lu G. Differences between karyotypically normal and abnormal human embryonic stem cells. Cell Prolif. 43(3),195-206 (2010).
37. Gore A, Li Z, Fung HL, Young JE et al. Somatic coding mutations in human induced pluripotent stem cells. Nature 471(7336), 63-67(2011).
38. Sugiura M, Kasama Y, Araki R et al. Induced pluripotent stem cell generation-associated point mutations arise during the initial stages of the conversion of these cells. Stem Cell Reports 2, 52-63 (2014).
39. Avery S, Hirst A, Baker D et al. BCL-XL mediates the strong selective advantage of a 20q11.21 amplification commonly found in human embryonic stem cell cultures. Stem Cell Reports 1, 379-386 (2013).
40. Närvä E, Autio R, Rahkonen N et al. High-resolution DNA analysis of human embryonic stem cell lines reveals culture-induced copy number changes and loss of heterozygosity. 28, 371-377 (2010).
41. Chen KG, Mallon BS, McKay RDG, Robey PG. Human pluripotent stem cell culture: considerations for maintenance, expansion, and therapeutics. Cell Stem Cell 14, 13-26 (2014).
42. Anguiano A, Wang B, Wang S et al. Spectral Karyotyping for identification of constitutional chromosomal abnormalities at a national reference laboratory. Mol. Cytogenet. 5, 3 (2012)
43. Das K, Tan P. Molecular cytogenetics: recent developments and applications in cancer. Clin. Gen. 84, 315-325(2013).
44. Moralli D, Yusuf M, Mandegar MA, Khoja S, Monaco ZL, Volpi EV. An improved technique for chromosomal analysis of human ES and iPS cells. Stem Cell Rev. Reports 7, 471-477 (2011).
45. Peterson SE, Westra JW, Rehen SK et al. Normal human pluripotent stem cell lines exhibit pervasive mosaic aneuploidy. PLoS One 6, e23018 (2011).
46. Riegel M. Human molecular cytogenetics: from cells to nucleotides. Genetics Mol. Biol. 37, 194-209 (2014).
47. Ben-David U, Mayshar Y, Benvenisty N. Vurtual karyotyping of pluripotent stem cells on the basis of their global gene expression profiles. Nat. Protocols 8, 989-997 (2013)
48. Zhang F, Gu W, Hurles M, Lupski J. Copy number variation in human health, disease and evolution. Ann. Rev. Hum. Genet. 10, 451-481 (2009).
49. Liang G, Zhange Y. Embryonic stem cell and induced pluripotent stem cell: an epigenetic perspective. Cell Res. 23, 49-69 (2013).
50. Liang G and Zhange Y. Genetic and epigenetic variations in iPSCs: potential consequences and implications for application. Cell Stem Cell 13, 149-159 (2013).
51. Frost J, Monk D, Moschidou D, Guillot PV, Stanier P, Minger SL, Fisk NM, Moore HD, Moore GE. The effects of culture on genomic imprinting profiles in human embryonic and fetal mesenchymal stem cells. Epigenetics 6(1), 52-62 (2011).
52. Nazor KL, Altun G, Lynch C et al. Recurrent variations in DNA methylation in human pluripotent stem cells and their differentiated derivatives. Cell Stem Cell 10(5), 620-634 (2012).
53. Tompkins J, Hall C, Chen V et al. Epigenetic stability, adaptability, and reversibility in human embryonic stem cells. Proc. Natl Acad. Sci. USA 109(31), 12544-12549 (2012).
54. Association for Clinical Cytogenetics: Professional Guidelines for Clinical Cytogenetics Constitutional Postnatal Chromosomal Microarray Best Practice Guidelines. Volume 2 (2011).
55. Gropp M, Shilo V, Vainer G et al. Standardization of the teratoma assay for analysis of pluripotency of human ES cells and biosafety of their differentiated progeny. PLoS One 7(9), e45532 doi:10.1371/journal.pone.0045532 (2012).
56. Buta C, David R, Dressel R et al. Reconsidering pluripotency tests: do we still need teratoma assays? Stem Cell Res. 11(3), 1022-1036 (2013).
57. Aleckovic M, Simón C. Is teratoma formation in stem cell research a characterization tool or a window to developmental biology? Reprod. Biomed. Online 17, 270-280 (2008).
58. Prokhorova TA, Harkness LM, Frandsen U et al. Teratoma formation by human embryonic stem cells is site dependent and enhanced by the presence of Matrigel. Stem Cells Dev. 18(1),47-54 (2009).
59. Quintana E, Shackleton M, Sabel MS, Fullen DR, Johnson TM, Morrison SJ. Efficient tumor formation by single human melanoma cells. Nature 456, 593-598 (2008).
60. Ito M, Hiramatsu H, Kobayashi K et al. NOD/SCID/gamma(c)(null) mouse: an excellent recipient mouse model for engraftment of human cells. Blood 100, 3175-3182 (2002).
61. Kanemura H, Go MJ, Shikamura M et al. Tumorigenicity studies of induced pluripotent stem cell (iPSC)-derived retinal pigment epithelium (RPE) for the treatment of age-related macular degeneration. PLoS One 14, e85336 (2014).
62. Shultz LD, Lyons BL, Burzenski LM. Human lymphoid and myeloid development in NOD/LtSz-scid ILR2 gamma null mice engrafted with mobilised human hemopoetic stem cells. J. Immunol. 174, 6477-6489 (2005).
63. Coecke S, Balls M, Bowe G et al. Guidance on Good Cell Culture Practice. A report of the second ECVAM Task Force on Good Cell Culture Practice, ATLA, 2005, 33, 1-27.
64. Andrews P. From teratocarcinomas to embryonic stem cells. Philos. Trans. R Soc. Lond. B Biol. Sci. 357(1420), 405-17 (2002).
65. Solter D. From teratocarcinomas to embryonic stem cells and beyond: a history of embryonic stem cell research. Nat. Rev. Genet. 7(4),319-27 (2006).
66. Croce CM. Oncogenes and cancer. N. Engl. J. Med. 358, 502-511 (2008).
67. Kerrigan L,Nims RW. Authentication of human cell-based products: the role of a new consensus standard. Regen. Med. 6(2), 255-260 (2011).
68. Knoppers BM, Isasi R, Benvenisty N et al. Publishing SNP genotypes of human embryonic stem cell lines: policy statement of the International Stem Cell Forum Ethics Working Party. Stem Cell Rev. 7(3), 482-4 (2001).
69. Luong MX, Auerbach J, Crook JM et al. A call for standardized naming and reporting of human ESC and iPSC lines. Cell Stem Cell 8(4), 357-359.
70. O'Connor MD, Kardel MD, Iosfina I et al.Alkaline phosphatase-positive colony formation is a sensitive, specific, and quantitative indicator of undifferentiated human embryonic stem cells. Stem Cells 26, 1109-1116 (2008).
71. Calloni R, Cordero EA, Henriques JA, Bonatto D. Reviewing and updating the major molecular markers for stem cells. Stem Cells Dev. 22, 1455-1476 (2013).
72. Zhao W, Ji X, Zhang F, Li L, Ma L. Embryonic stem cell markers. Molecules 17, 6196-6236 (2012).
73. ISCI. International Stem Cell Initiative. Adewumi O, Aflatoonian B, Ahrlund-Richter L et al. Characterization of human embryonic stem cell lines by the International Stem Cell Initiative. Nat. Biotechnol. 25, 803-816 (2007).
74. Josephson R, Ording CJ, Liu Y et al. Qualification of embryonal carcinoma 2102Ep as a reference for human embryonic stem cell research. Stem Cells 25, 437-446 (2007).
75. Loring JF, Rao MS. Establishing standards for the characterization of human embryonic stem cell lines. Stem Cells 24(1), 145-50 (2006).
76. Durruthy-Durruthy J, Briggs S, Awe J et al. Rapid and efficient conversion of integration-free human induced pluripotent stem cells to GMP-grade culture conditions. PLoS One 204, 9, e94231.
77. Goh PA, Caxaria S, Casper C, Rosales C, Warner TT, Coffey PJ, Nathwani AC. A systematic evaluation of integration free reprogramming methods for deriving clinically relevant patient specific induced pluripotent stem (iPS) cells. PLoS One 8(11), e81622 (2013).
78. Müller FJ, Goldmann J, Löser P, Loring JF. A call to standardize teratoma assays used to define human pluripotent cell lines. Cell Stem Cell 6, 412-414 (2010).
79. Müller FJ, Schuldt BM, Williams R et al. A bioinformatic assay for pluripotency in human cells. Nat. Methods 8(4), 315-317 (2001).
80. Müller FJ, Brändl B, Loring JF. Assessment of human pluripotent stem cells with PluriTest. StemBook [Internet]. Cambridge (MA, USA), Harvard Stem Cell Institute, 2008-2012.
81. Bock, C, Kiskinis E, Verstappen G et al. Reference maps of human ES and iPS cell variation enable high-throughput characterization of pluripotent cell lines. Cell 144(3), 439-52 (2001).
82. Sheridan SD, Surampudi V, Rao RR. Analysis of embryoid bodies derived from human induced pluripotent stem cells as a means to assess pluripotency. Stem Cells Int. 73, 8910 (2012).
83. USFDA. Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps). (2011)
84. EudraLex. EudraLex Volume 4, Chapter 1 (2011). http://ec.europa.eu/health/files/eudralex/vol-4/pdfs-en/2008-02-14-gmp-part1-chapter1-q9-en.pdf
85. MHRA. Rules and Guidance for Pharmaceutical manufacturers and Distributors. 2014. http://www.mhra.gov.uk/Publications/Regulatoryguidance/Medicines/CON2030291
86. World Health Organization (2006). Annex 4 Supplementary guidelines on GMPs: validation, WHO Technical Report Series, No. 937, (2006). http://apps.who.int/prequal/info-general/documents/TRS937/WHO-TRS-937-Annex4.pdf
87. World Health Organisation (2007). Quality assurance of pharmaceuticals: A compendium of guidelines and related materials, Volume 2, 2nd Updated Edition, Good Manufacturing Practices And Inspection. (2007). www.who.int/vaccines-documents/DocsPDF/www9666.pdf
88. EUTCD (2004). Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. (2004). http://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32004L0023
89. Beck G, Schenerman M, Dougherty J et al. Raw material control strategies for bioprocesses. BioProcess International 18-33 (2009).
90. Melton L, and Wahlgren C. Participating in the Rx360 pilot joint audit programme: a suppliers perspective. BioProcess International 10(10), 20-23 (2012).
91. Unger C, Skottman H, Blomberg P, Dilber MS, Hovatta O. Good manufacturing practice and clinical-grade human embryonic stem cell lines. Hum. Mol. Genet. 17(R1), R48-53(2008)
92. USFDA 2008. Guidance for FDA reviewers and sponsors: content and review of chemistry, manufacturing, and control (CMC) information for human somatic cell therapy investigational new drug applications (INDs).
93. PAS 93. Characterization of Human Cells for Clinical Applications. BSI Standards Limited. (2011).
94. Sheridan B, Stacey G, Wilson A, Ginty P, Bravery C, Marshall D. Standards can help bring cell therapy products to market. BioProcess International 10(4), 18-20 (2012).
95. Andrews P, Cavagnaro J, Deans R et al. Harmonizing standards for producing clinical-grade therapies from pluripotent stem cells. Nat. Biotechnol. 32, 724-726 (2014).
96. Benson EE, Betsuo F, Fuller BJ, Harding K, Kofanova O. Translating cryobiology principles into transdisciplinary storage guidelines for biorepositories and biobanks: a concept paper. Cryoletters 34, 277-312(2013).
97. Pegg D. Cryopreservation and Freezedrying Methods. Day DG, Stacey GN (Eds). Humana Press, Totowa, USA, 39-58 (2007).
98. Pegg D. Viability assays for preserved cells, tissues, and organs. Cryobiology 26, 212-231 (1989).
99. Fahy GM, Wowk B, Wu J, Paynter S. Improved vitrification solutions based on the predictability of vitrification solution toxicity. Cryobiology 48(1), 22-35 (2004).
100. - 100 Hunt CJ. Cryopreservation of human stem cells for clinical application: a review. Transfus. Med. Hemother. 38(2), 107-123 (2011).
101. Day JG, Stacey GN. Cryopreservation and Freeze-drying Protocols. Day DG, Stacey GN (Eds). Humana Press, Totowa, USA (2007).
102. Lawrence D. Stem cells in toxicology. Curr. Protocol. Toxicol. 47, 22:22.0.1 (2011).
103. Inoue H, Yamanaka S. The use of induced pluripotent stem cells in drug development. Clin. Pharmacol. Therap. 89 (5), 655-661 (2011).
104. Pistollato F, Bremer-Hoffmann S, Healy L, Young L, Stacey G. Standardization of pluripotent stem cell cultures for toxicity testing. Exp. Opin. Drug Metab. Toxicol. 8(2), 239-257 (2012).
105. ICHQA (R1). Quality of Biotechnological Products: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin. Geneva (1997). www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2009/09/WC500002801.pdf
106. ICH Q 3A-3D: Impurities. Geneva. 2006-2014. www.ich.org/products/guidelines/quality/quality-single/article/impurities-in-new-drug-substances.html
107. Code of Federal Regulations PART 1271 - Human cells, Tissues, and Cellular and Tissue-based Products FDA, 21 CFR 1271.3(y). Revised as of April 1, 2013. www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=1271.3
108. International Conference On Harmonisation Of Technical Requirements For Registration Of Pharmaceuticals For Human Use. ICH Harmonised Tripartite Guideline. Clinical Safety Data Management: Definitions And Standards For Expedited Reporting E2A. www.ich.org/fileadmin/Public-Web-Site/ICH-Products/Guidelines/Efficacy/E2A/Step4/E2A-Guideline.pdf
109. Wang L, Pegg DE, Lorrison J, Vaughan D, Rooney P. Further work on the cryopreservation of articular cartilage with particular reference to the liquidus tracking (LT) method. Cryobiology 55(2),138-47 (2007).
110. Wowk B, Leitl E, Rasch CM, Mesbah-Karimi N, Harris SB, Fahy GM. Vitrification enhancement by synthetic ice blocking agents. Cryobiology 40(3), 228-236 (2007).
111. Morris GJ, Acton E. Controlled ice nucleation in cryopreservation - a review. Cryobiology 66, 85-92 (2013).
112. Morris GJI, Acton E, Faszer K et al. Cryopreservation of murine embryos, human spermatozoa and embryonic stem cells using a liquid nitrogen-free, controlled rate freezer. Reprod. Biomed. Online 13(3), 421-426 (2006).
113. Morris GJ, Acton E, Collins D, Bos-Mikich A, de Sousa P. Optimisation of current Good Manufacturing Practice (cGMP) compliant controlled rate freezing for human embryonic stem cells. Cryobiology 61, 406 (2010).