Guidance for removal of fetal bovine serum from cryopreserved heart valve processing

Cells Tissues Organs

Volumn 193, Issue 4, 2011, Pages 264-273

  Brockbank, Kelvin G M ^a,b   Heacox, Albert E ^c   Schenke Layland, Katja ^d,e  

^a Cell and Tissue Systems Inc   (United States)

^b GEORGIA INSTITUTE OF TECHNOLOGY   (United States)

^c CRYOLIFE INC   (United States)

^d UNIVERSITY OF CALIFORNIA   (United States)

^e FRAUNHOFER INSTITUTE FOR INTERFACIAL ENGINEERING AND BIOTECHNOLOGY IGB   (Germany)

Author keywords

Cryopreservation; Extracellular matrix; Fetal bovine serum; Heart valves; Viability

Indexed keywords

DEXTRAN 40; DIMETHYL SULFOXIDE;

ANIMAL TISSUE; ARTICLE; AUTOFLUORESCENCE IMAGING; BIOMECHANICS; COLLOID; CONCENTRATION (PARAMETERS); CONTROLLED STUDY; COW; CRYOPRESERVATION; CRYOPROTECTION; HEART VALVE; HISTOLOGY; MICROSCOPY; NONHUMAN; PRIORITY JOURNAL; SERUM; WARMING;

ANIMALS; BIOMECHANICS; CATTLE; CRYOPRESERVATION; FETUS; HEART VALVES; MICROSCOPY, FLUORESCENCE, MULTIPHOTON; SERUM; SUS SCROFA; TISSUE CULTURE TECHNIQUES; TISSUE SURVIVAL;

BOVINAE; SUS;

EID: 79952576023     PISSN: 14226405     EISSN: None     Source Type: Journal    
DOI: 10.1159/000321166     Document Type: Article

References (52)

1. Asher, D.M. (1999) The transmissible spongiform encephalopathy agents: concerns and responses of United States regulatory agencies in maintaining the safety of biologics. Dev Biol Stand 100: 103-118.
2. Bradley, R. (2004) Bovine spongiform encephalopathy and its relationship to the variant form of Creutzfeldt-Jakob disease. Contrib Microbiol 11: 146-185.
3. Brockbank, K.G.M. (2007) Current practices in heart valve preservation. Part 1. Bioprocessing 6: 29-36.
4. Brockbank, K.G.M., F.G. Lightfoot, Y.C. Song, M.J. Taylor (2000): Interstitial ice formation in cryopreserved homografts: a possible cause of tissue deterioration and calcification in vivo. J Heart Valve Dis 9: 200-206. (Pubitemid 30187001)
5. Brown, P., R.G. Will, R. Bradley, D.M. Asher, L. Detwiler (2001) Bovine spongiform encephalopathy and variant Creutzfeldt-Jakob disease: background, evolution, and current concerns. Emerg Infect Dis 7: 6-16. (Pubitemid 32173328)
6. Campbell, L.H., K.G.M. Brockbank (2007) Serum-free solutions for cryopreservation of cells. In Vitro Cell Dev Biol Anim 43: 269-275.
7. Committee for Veterinary Medicinal Products (2001) Guideline on requirements and controls applied to bovine serum used in the production of immunological veterinary medicinal products. EMEA/CVMP/743-00. London, European Medicines Agency.
8. Croes, E.A., C.M. van Duijn (2003) Variant Creutzfeldt-Jakob disease. Eur J Epidemiol 18: 473-477. (Pubitemid 36899550)
9. Dahl, S., Z. Chen, A. Solan, F. Lightfoot, C. Li, K.G.M. Brockbank, L. Niklason, Y.C. Song (2006) Tissue engineered blood vessels. Tissue Eng 12: 291-300.
10. Elder, E., Z. Chen, A. Ensley, R. Nerem, K. Brockbank, Y. Song (2005) Enhanced tissue strength in cryopreserved, collagen-based blood vessel constructs. Transplant Proc 37: 4625-4629. (Pubitemid 43016096)
11. Erickson, G.A., S.R. Bolin, J.G. Landgraf (1991) Viral contamination of fetal bovine serum used for tissue culture: risks and concerns. Dev Biol Stand 75: 173-175.
12. Erickson, G.A., J.G. Landgraf, S.J. Wessman, T.A. Koski, L.M. Moss (1989) Detection and elimination of adventitious agents in continuous cell lines. Dev Biol Stand 70: 59-66.
13. Food and Drug Administration (1998) International Conference on Harmonisation; guidance on quality of biotechnological/biological products: derivation and characterization of cell substrates used for production of biotechnological/ biological products; availability. Notice. Food and Drug Administration, HHS. Fed Regist 63: 50244-50249.
14. Food and Drug Administration (2001) BSE estimating risks for vCJD in vaccines using bovine- derived materials. http://www.fda.gov/cber/bse/risk.htm.
15. Froud, S.J. (1999) The development, benefits and disadvantages of serum-free media. Dev Biol Stand 99: 157-166.
16. Gerson, C.J., S. Goldstein, A.E. Heacox (2009) Retained structural integrity of collagen and elastin within cryopreserved human heart valve tissue as detected by two-photon laser scanning confocal microscopy. Cryobiology 59: 171-179.
17. Gonzalez-Lavin, L., L.B. McGrath, S. Amini, D. Graf (1988) Homograft valve preparation and predicting viability at implantation. J Card Surg 3: 309-312.
18. Hilbert S.L., R.E. Luna, J. Zhang, Y. Wang, R.A. Hopkins, Z.X. Yu, V.J. Ferrans (1999) Allograft heart valves: the role of apoptosismediated cell loss. J Thorac Cardiovasc Surg 117: 454-462. (Pubitemid 29117524)
19. Irani, D. N., R.T. Johnson (2003) Diagnosis and prevention of bovine spongiform encephalopathy and variant Creutzfeldt-Jakob disease. Annu Rev Med 54: 305-319. (Pubitemid 37386399)
20. Ironside, J.W., M.W. Head (2003) Variant Creutzfeldt-Jakob disease and its transmission by blood. J Thromb Haemost 1: 1479-1486.
21. Jayme, D.W. (1999) An animal origin perspective of common constituents of serum-free medium formulations. Dev Biol Stand 99: 181-187.
22. Jennings, A. (1999) Detecting viruses in sera: methods used and their merits. Dev Biol Stand 99: 51-59.
23. Jonas, R.A., G. Ziemer, L. Britton, L.C. Armiger (1988) Cryopreserved and fresh antibioticsterilized valved aortic homograft conduits in a long-term sheep model. J Thorac Cardiovasc Surg 96: 746-755.
24. König, K., K. Schenke-Layland, I. Riemann, U.A. Stock (2005) Multiphoton autofluorescence imaging of intratissue elastic fibers. Biomaterials 26: 495-500. (Pubitemid 38969979)
25. Lee, J.M., D.R. Boughner (1981) Tissue mechanics of canine pericardium in different test environments. Evidence for time-dependent accommodation, absence of plasticity, and new roles for collagen and elastin. Circ Res 49; 533-544.
26. Lee, J.M., D.W. Courtman, D.R. Boughner (1984) The glutaraldehyde- stabilized porcine aortic valve xenograft. I. Tensile viscoelastic properties of the fresh leaflet material. J Biomed Mater Res 18: 61-77.
27. Levings, R.L., S.J. Wessman (1991) Bovine viral diarrhea virus contamination of nutrient serum, cell cultures and viral vaccines. Dev Biol Stand 75: 177-181.
28. Makoschey, B., P.T. van Gelder, V. Keijsers, D. Goovaerts (2003) Bovine viral diarrhoea virus antigen in foetal calf serum batches and consequences of such contamination for vaccine production. Biologicals 31: 203-208. (Pubitemid 36993716)
29. McNally, R.T., A. Heacox, K.G.M. Brockbank, H.L. Bank (1990) Method for cryopreserving heart valves. US Patent No 4890457.
30. Merten, O.W. (1999) Safety issues of animal products used in serum-free media. Dev Biol Stand 99: 167-180.
31. Nakayama, S., T. Ban, S. Okamoto (1994) Fetal bovine serum is not necessary for the cryopreservation of aortic valve tissues. J Thorac Cardiovasc Surg 108: 583-586. (Pubitemid 24299686)
32. Narine, K., E.C. Ing, M. Cornelissen, F. Desomer, H. Beele, L. Vanlangenhove, S. De Smet, G. Van Nooten (2006) Readily available porcine aortic valve matrices for use in tissue valve engineering. Is cryopreservation an option? Cryobiology 53: 169-181. (Pubitemid 44353449)
33. Nuttall, P.A., P.D. Luther, E.J. Stott (1977) Viral contamination of bovine foetal serum and cell cultures. Nature 266: 835-837. (Pubitemid 8074715)
34. O'Brien, J., I. Wilson, T. Orton, F. Pognan (2000) Investigation of the Alamar Blue (resazurin) fluorescent dye for the assessment of mammalian cell cytotoxicity. Eur J Biochem 267: 5421-5426.
35. O'Brien, M., E.G. Stafford, M.A. Gardner, P.G. Pohlner, D.C. McGiffin (1987) A comparison of aortic valve replacement with viable cryopreserved and fresh allograft valves with a note on chromosomal studies. J Thorac Cardiovasc Surg 94: 812-823. (Pubitemid 18006850)
36. Pearson, K., N. Dock, S. Brubaker (eds) (2008) Standards for Tissue Banking, ed 12. McLean, American Association of Tissue Banks.
37. Pegg, D.E. (2010) The relevance of ice crystal formation for the cryopreservation of tissues and organs. Cryobiology 60(3 suppl): S36-S44.
38. Reuther, T., C. Kettmann, M. Scheer, M. Kochel, S. Lida, A. Kubler (2006) Cryopreservation of osteoblast-like cells: viability and differentiation with replacement of fetal bovine serum in vitro. Cells Tissues Organs 183: 32-40. (Pubitemid 44401341)
39. Ross, D. (1962) Homograft replacement of the aortic valve. Lancet ii: 487.
40. Schenke-Layland, K. (2008) Non-invasive multiphoton maging of extracellular matrix structures. J Biophotonics 1: 451-462.
41. Schenke-Layland, K., N. Madershahian, I. Riemann, B. Starcher, K.J. Halbhuber, K. König, U.A. Stock (2006) Impact of cryopreservation on extracellular matrix structures of heart valve leaflets. Ann Thorac Surg 81: 918-926. (Pubitemid 43247661)
42. Schenke-Layland, K., J. Xie, S. Haydarkhan- Hagvall, S.F. Hamm-Alvarez, U.A. Stock, K.G.M. Brockbank, W.R. MacLellan (2007) Optimized preservation of extracellular matrix damage in cardiac tissues: implications for long-term graft durability. Ann Thorac Surg 83: 1641-1650. (Pubitemid 46616768)
43. Taylor, M.J., L.H. Campbell, R.N. Rutledge, K.G.M. Brockbank (2001) Comparison of Unisol(TM) with Euro-Collins solution as a vehicle solution for cryoprotectants. Transplant Proc 33: 677-679. (Pubitemid 32237569)
44. Thakrar, R.R., V.P. Patel, G. Hamilton, B.J. Fuller, A.M. Seifalian (2006) Vitreous cryopreservation maintains the viscoelastic property of human vascular grafts. FASEB J 20: 874-881. (Pubitemid 44943946)
45. Trevitt, C.R., P.N. Singh (2003) Variant Creutzfeldt-Jakob disease: pathology, epidemiology, and public health implications. Am J Clin Nutr 78: 651S-656S.
46. Tuna, I.C., T.A. Orszulak, H.V. Schaff, G.K. Danielson (1990) Results of homograft aortic valve replacement for active endocarditis. Ann Thorac Surg 49: 619-624. (Pubitemid 20149263)
47. Vesely I., L. Gonzalez-Lavin, D. Graf, D. Boughner (1990) Mechanical testing of cryopreserved aortic allografts. Comparison with xenografts and fresh tissue, J Thorac Cardiovasc Surg 99: 119-123. (Pubitemid 20041523)
48. Ward, H.J., M.W. Head, R.G. Will, J.W. Ironside (2003) Variant Creutzfeldt-Jakob disease. Clin Lab Med 23: 87-108. (Pubitemid 36514041)
49. Weber, D.J. (2004) Biosafety considerations for cell-based therapies. Biopharm Int 17: 48-55.
50. Wessman, S.J., R.L. Levings (1999) Benefits and risks due to animal serum used in cell culture production. Dev Biol Stand 99: 3-8.
51. Will, R.G., J.W. Ironside, M. Zeidler, S.N. Cousens, K. Estibeiro, A. Alperovitch, S. Poser, M. Pocchiari, A. Hofman, P.G. Smith (1996) A new variant of Creutzfeldt-Jakob disease in the UK. Lancet 347: 921-925. (Pubitemid 26102546)
52. Zabal, O., A.L. Kobrak, I.A. Lager, A.A. Schudel, E.L. Weber (2000) Contamination of bovine fetal serum with bovine viral diarrhea virus (in Spanish). Rev Argent Microbiol 32: 27-32. (Pubitemid 30205094)