Standards in cell and tissue engineering

Standardisation in Cell and Tissue Engineering: Methods and Protocols

Volumn , Issue , 2013, Pages 107-126

  Tomlins, P ^a  

^a Englefield Green   (United Kingdom)

Author keywords

Characterization; Materials; Standards; Tissue engineering; Tissue scaffolds

Indexed keywords

CELL ENGINEERING; CHARACTERIZATION; MATERIALS; SCAFFOLDS (BIOLOGY); STANDARDS; TISSUE;

BEST PRACTICES; CELL BEHAVIOURS; CELL TYPES; DELIVERY ROUTES; GUIDANCE DOCUMENT; TECHNICAL CHALLENGES; TISSUE SCAFFOLDS;

TISSUE ENGINEERING;

EID: 84903811039     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1533/9780857098726.2.107     Document Type: Chapter

References (60)

1. Advanced Therapy Medicinal Products Directive 2001/83/EC. Since updated, see Regulation (EC) No 1394/2007 1983.
2. Agrawal C.M., McKinney J.S., Lanctot D., Athanasiou K.A. Effects of fluid flow on the in vitro degradation kinetics of biodegradable scaffolds for tissue engineering. Biomaterials 2000, 21(23):2443-2452.
3. ASTM Dictionary of Engineering Science and Technology. http://www.astm.org.
4. ASTM F2900-11 Standard Guide for Characterization of Hydrogels used in Regenerative Medicine http://www.astm.org.
5. BSI BS5750 part 1: Quality systems. Specification for design, manufacture and installation 1979, http://www.bsi.org.
6. BSI BSI PAS 84:2008 Regenerative Medicine - Glossary http://www.bsi.org.
7. Darcy H. Les fontaines publiques de la ville de Dijon 1856, Dalmont, Paris.
8. Davies J., Lam J.K.W., Tomlins P.E., Marshall D. An in vitro multi-parametric approach to measuring the effect of implant surface characteristics on cell behaviour. Biomedical Materials 2010, 5:15002-15008. 10.1088/1748-6041/5/1/015002.
9. Standard Test Method for Permeabilty of Rocks by Flowing Air 2008, D4525-08. http://www.astm.org.
10. Deligiannia D.D., Katsalaa N., Ladasb S., Sotiropouloub D., Amedeec J., Missirlisa Y.F. Effect of surface roughness of the titanium alloy Ti-6Al-4V on human bone marrow cell response and on protein adsorption. Biomaterials 2001, 22(11):1241-1251.
11. European Commission Medical Device Directive (Council Directive 93/42/ EEC of 14 June 1993 concerning medical devices, OJ No L 169/1 of 1993-07-12) 2003.
12. Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices 2010, F748-06. http://www.astm.org.
13. Standard Guide for Characterization and Testing of Raw or Starting Biomaterials for Tissue Engineered medical Products 2008, F2027-08. http://www.astm.org.
14. Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue Engineered Medical Products 2007, F2150-07. http://www.astm.org.
15. ASTM F2210-02(2010) Standard Guide for Processing Cells, Tissues, and Organs for Use in Tissue Engineered Medical Product 2010, F2210-2. http://www.astm.org.
16. Standard Classification for Tissue Engineered Medical Products (TEMPs) 2004, F2211-04. http://www.astm.org.
17. Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs) 2009, F2212-09. http://www.astm.org.
18. Standard Guide for the Immobilization or Encapsulation of Living Cells or Tissue in alginate Gels 2011, F2315-11. http://www.astm.org.
19. Standard Guide for Assessment of Adventitious Agents in Tissue Engineered Medical Products (TEMPs) 2011, F2383-11. http://www.astm.org.
20. Standard Guide for Preservation of Tissue Engineered Medical Products 2004, F2386-04. http://www.astm.org.
21. Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue Engineered Medical Products 2010, F2450-10. http://www.astm.org.
22. Standard Guide for in vivo Assessment of Implantable Devices Intended to Repair or Regenerate Articular Cartilage 2010, F2451-10. http://www.astm.org.
23. Standard Guide for Interpreting Images of Polymeric Tissue Scaffolds 2006, F2603-06. http://www.astm.org.
24. Standard Guide for assessing the attachment of cells to biomaterial surfaces by Physical Methods 2007, F2664-07.
25. Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects 2009, F2721-09. http://www.astm.org.
26. Standard Guide for Quantitating Cell Viability within biomaterial scaffolds 2008, F2739-08. http://www.astm.org.
27. Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions 2009, F2791-09. http://www.astm.org.
28. FDA Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications 2010, http://www.fda.gov/downloads/biologicsbloodvaccines/ucm202439.pd.
29. Glowacki J., Mizuno S. Collagen scaffolds for tissue engineering. Biopolymers 2008, 89(5):338-344.
30. Haug A., Larsen B., Baardseth E. Comparison of the constitution of alginates from different sources. Proc VI Int Seaweed Symp 1969, 443-451.
31. Hedberg E.L., Kroese-Deutman H.C., Shih C.K., Crowther R.S., Carney D.H., Mikos A.G., Jansen J.A. In vivo degradation of porous poly(propylene fumarate)/poly(DL-lactic-co-glycolic acid) composite scaffolds. Biomaterials 2005, 26(22):4616-4623. Epub 18 January 2005.
32. ISO ISO 4287:1997 Geometrical Product Specifications (GPS) - Surface texture: Profile method - Terms, definitions and surface texture parameters 1997, http://www.iso.org.
33. ISO ISO 9000:2005. Quality management systems - fundamentals and vocab- ulary.ISO (2008) ISO 9001:2008. Quality management systems - requirements 2005, http://www.iso.org.
34. ISO 10993 parts 1-20. Details of these documents can be found at . http://www.iso.org.
35. ISO ISO 10993-13: 2010. Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices 2010, http://www.iso.org.
36. ISO ISO 13408 Aseptic Processing of Health Care Products Package 2003-2008, http://www.iso.org.
37. ISO ISO 13485:2003. Medical devices - quality management systems - requirements for regulatory purposes 2003, http://www.iso.org.
38. Jacchetti E., Emilitri E., Rodighiero S., Indrieri M., Gianfelice A., Lenardi C., Podestà A., Ranucci E., Ferruti P., Milani P. Biomimetic poly(amidoamine) hydrogels as synthetic materials for cell culture. Journal of Nanobiotechnology 2008, 6:14. 10.1186/1477-3155-6-1.
39. Johnson P.C., Bertram T.A., Tawil B., Hellman K.B. Hurdles in tissue engineering/regenerative medicine product commercialization: a survey of North American academia and industry. Tissue Engineering Part A 2011, 17(1-2):5-15.
40. Kaplan D.S., Hitchins V.M., Vegella T.J., Malinauskas R.A., Frondoza C.G., Kimberly M., Ferlin K.M., Fisher J.P. Centrifugation assay for measuring adhesion of serially-passaged bovine chondrocytes to polystyrene surfaces. Tissue Engineering Part C: Methods 2012, 18(7):537-544.
41. Li Z., Ramay H.R., Hauch K.D., Xiao D., Zhang M. Chitosan-alginate hybrid scaffolds for bone tissue engineering. Biomaterials 2005, 26(18):3919-3928.
42. Liu H., Li X., Zhou G., Fan H., Fan Y. Electrospun sulfated silk fibroin nanofibrous scaffolds for vascular tissue engineering. Biomaterials 2011, 32(15):3784-3793. Epub 3 March 2011.
43. Mason C., Dunnill P. A brief definition of regenerative medicine. Regenerative Medicine 2008, 3:1.
44. Miller I.J. Alginate composition of some New Zealand brown Seaweeds. Phytochemistry 1996, 41:1315-1317.
45. Messenger M.P., Tomlins P.E. Regenerative medicine: a snapshot of the current regulatory environment and standards. Advanced Materials 2011, 23(12):H10-H17.
46. Mather M.L., Morgan S.P., White L.J., Tai H., Kockenberger W., Howdle S.M., Shakesheff K.M., Crowe J.A. Image-based characterization of foamed polymeric tissue scaffolds. Biomedical Materials 2008, 3:15011-15022.
47. Mouriño V., Newby P., Boccaccini A.R. Preparation and characterization of gallium releasing 3-D alginate coated 45S5 Bioglass® based scaffolds for bone tissue engineering. Advanced Engineering Materials 2010, 12(7):B283-B291.
48. Otsu N. A threshold selection method from gray-level histograms. IEEE Transactions on Systems Man and Cybernetics 1979, 9(1):62-66. 10.1109/ TSMC.1979.4310076.
49. Pêgo A.P., Siebum B., Van Luyn M.J., Gallego y Van Seijen X.J., Poot A.A., Grijpma D.W., Feijen J. Preparation of degradable porous structures based on 1,3-trimethylene carbonate and D,L-lactide (co)polymers for heart tissue engineering. Tissue Engineering 2003, 9(5):981-994.
50. Plagnol A.C., Rowley E., Martin P., Livesey F. Industry perceptions of barriers to commercialization of regenerative medicine products in the UK. Regenerative Medicine 2009, 4(4):549-559.
51. RM 8396 - Tissue Engineering Reference, Scaffold available from . http://www.nist.gov.
52. South G.R. Alginate levels in New Zealand Durvillaea (Phaeophyceae), with particular reference to age variations in D. Antarctica 1979, 9:133-142. i.e. Symp, (9).
53. The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010, http://www.legislation.gov.uk/uksi/2010/1882/schedules/made.
54. Torrisi L., Mondio G., Miracoli R., Torrisi A. Laser and electron beams physical analyses applied to the comparison between two silver tetradrachm Greek coins. 35th EPS Conference on Plasma Phys. Hersonissos 2008, 32D. 9-13 June 2008 ECA 4.170.
55. Trieu H.H., Qutubuddin S. Polyvinyl alcohol hydrogels I. Microscopic structure by freeze-etching and critical point drying techniques. Colloid and Polymer Science 1994, 272(3):301-309. 10.1007/BF00655501.
56. Wang C.C., Yang K.C., Lin K.H., Liu Y.L., Liu H.C., Lin F.H. Cartilage regeneration in SCID mice using a highly organized three-dimensional alginate scaffold. Biomaterials 2012, 33(1):120-127. Epub 5 Oct 2011.
57. Wang Y., Tomlins P.E., Coombes A.G.A., Rides M. On the determination of Darcy permeability coefficients for a microporous tissue scaffold. Tissue Engineering Part C 2010, 16(2):281-289.
58. Weir N.A., Buchanan F.J., Orr J.F., Farrar D.F., Dickson G.R. Degradation of poly L lactide. Prat 2: Increased temperature accelerated degradation. Proceedings of the Institution Mechanical Engineers, Engineering in Medicine 2004, 218(H):321.
59. Wu L., Ding J. In vitro degradation of three-dimensional porous poly(DL lactide-co-glycolide) scaffolds for tissue engineering. Biomaterials 2004, 25:5821-5830.
60. Yoon J.J., Park T.G. Degradation behaviors of biodegradable macroporous scaffolds prepared by gas foaming of effervescent salts. Journal of Biomedical Materials Research 2001, 55(3):401-408.