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ASTM Selected Technical Papers
Tissue Engineered Medical Products (TEMPs)
By
E Schutte
E Schutte
editor
Search for other works by this author on:
GL Picciolo
GL Picciolo
editor
Search for other works by this author on:
D Kaplan
D Kaplan
editor
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ISBN-10:
0-8031-3471-1
ISBN:
978-0-8031-3471-3
No. of Pages:
272
Publisher:
ASTM International
Publication date:
2004

A prominent barrier to widespread commercialization of tissue engineered medical products (TEMPs) is the development of storage and transport technologies to maintain high product viability and integrity at point of use. Advances in biostabilization and low temperature biology have produced effective preservation technologies for cells and tissues in areas of hypothermic storage, cryopreservation by freezing and vitrification, and anhydrobiotic preservation. Preservation methods are anticipated to progress in step with development of TEMPs and may ultimately influence construct designs, as the final form of these products are determined. However, development of preservation methods is complex and requires optimization of several chemical and biophysical processes to achieve maximal viability and stability. The development of standards for materials and processes used in preserving TEMPs will be integral in ensuring final product quality and integrity pertaining to pre-process treatment, materials and containment systems, preservation processes, storage, transport, restoration and post-process treatment.

1.
Franks
,
F.
, “
The Properties of Aqueous Solutions at Subzero Temperatures
,”
Water: A Comprehensive Treatise
, Vol.
7
,
Franks
F.
, Ed.,
Plenum Press
,
New York
,
1982
.
2.
Taylor
,
M.J.
,
Elrifai
A.M.
, and
Bailes
,
J.E.
, “
Hypothermia in Relation to the Acceptable Limits of Ischemia for Bloodless Surgery
,”
Advances in Low Temperature Biology
, Vol
3
,
Steponkus
P.L.
, Ed.,
JAI Press
,
London UK and Greenwich, CT
,
1996
, pp. 1–64.
3.
Taylor
,
M.J.
, US Patent Serial # 5,405,742. April, 1995.
4.
Taylor
,
M.J.
, “
Biology of Cell Survival in the Cold
Transplantation: Principles and Practice
,
Dubernard
J.M.
and
McMaster
P.
, Eds.,
Harwood Academic Publishers
,
Amsterdam
, (In Press).
5.
Kruuv
,
J.
and
Lepock
,
J.R.
, “
Factors Influencing Survival of Mammalian Cells Exposed to Hypothermia. VI. Effects of Prehypothermic Hypoxia Followed by Aerobic or Hypoxic Storage at Various Hypothermic Temperatures
,”
Cryobiology
, Vol.
35
,
1995
, pp. 191–198.
6.
Kruuv
,
J.
,
Glofcheski
,
D.J.
and
Lepock
,
J.R.
, “
Evidence for Two Modes of Hypothermic Damage in Five Cell Lines
,”
Cryobiology
, Vol.
32
,
1995
, pp. 182–190.
7.
Kruuv
,
J.
, “
Survival of Mammalian Cells Exposed to Pure Hypothermia in Culture
”.
Advances in Molecular and Cell Biology, Vol. 19
,
JAI Press
.
Greenwich CT
,
1997
, pp. 143–192.
8.
Taylor
,
M.J.
and
Hunt
,
C.J.
, “
A New Preservation Solution for Storage of Corneas at Low Temperatures
,”
Current Eye Research
, Vol.
4
, No.
9
,
1985
, pp. 963–973.
9.
Brockbank
,
K.G.M.
and
Smith
,
K.M.
, “
Synergistic Interaction of Low-Molecular-Weight Poly-vinylpyrrolidones with Dimethyl Sulfoxide During Cell Preservation
.”
Transplant Proceedings
., Vol.
25
,
1993
, pp. 3185.
10.
Brockbank
,
K.G.M.
, U.S. Patent 5,145,769, and Patent 5,158,867,
1992
.
11.
Rail
,
W.F.
, “
Factors Affecting the Survival of Mouse Embryos Cryopreserved by Vitrification
,”
Cryobiology
, Vol.
24
,
1987
, pp. 387–402.
12.
Fahy
,
G.M.
, “
Vitrification
,”
Low Temperature Biotechnology: Emerging Applications and Engineering Contributions
,
McGrath
J.J.
and
Diller
K.R.
, Eds.,
American Society of Mechanical Engineers
,
New York
,
1988
, pp. 113–146.
13.
Jutte
,
N.H.P.M.
,
Heyse
,
P.
,
Jansen
,
H.G.
,
Bruining
,
G.J.
and
Zeilmaker
,
G.H.
, “
Vitrification of Mouse Islets of Langerhans: Comparison With a More Conventional Freezing Method
,”
Cryobiology
, Vol.
24
,
1987
, pp. 292–302.
14.
Jutte
,
N.H.P.M.
,
Heyse
,
P.
,
Jansen
,
H.G.
,
Bruining
,
G.J.
and
Zeilmaker
,
G.H.
, “
Vitrification of Human Islets of Langerhans
,”
Cryobiology
, Vol.
24
,
1987
, pp. 403–411.
15.
Van Wagtendonk-De Leeuw
,
A.M.
,
Den Daas
,
J.H.G.
,
Kruip
,
T.A.M.
and
Rail
,
W.F.
, “
Comparison of the Efficacy of Conventional Slow Freezing and Rapid Cryopreservation Methods for Bovine Embryos
,”
Cryobiology
Vol.
32
,
1995
, pp. 157–167.
16.
Boutron
,
P.
,
Mehl
,
P.
,
Kaufmann
,
A.
, and
Augibaud
,
P.
, “
Glass Forming Tendency and Stability of the Amorphous Stat in Aqueous Solutions of Polyalcohols with Four Carbons. I Binary Systems Water-Polyalcohols
,”
Cryobiology
 0011-2240, Vol.
23
,
1986
, pp. 453–469.
17.
Boutron
,
P.
, and
Mehl
,
P.
, “
Theoretical Predictions of Devitrification Tendency: Determination of Critical Warming Rates Using Finite Expansions
,”
Cryobiology
, Vol.
27
,
1990
, pp. 359–377.
18.
Brockbank
,
K.G.M.
,
Carpenter
,
J.F.
and
Dawson
,
P.E.
, “
Effects of Storage Temperature on Viable Bioprosthetic Heart Valves
,”
Cryobiology
, Vol.
29
,
1992
pp. 537.
19.
Karow
,
A.M.
, “
Biophysical and Chemical Considerations in Cryopreservation
,”
Organ Preservation for Transplantation
,
Karow
A.M.
and
Pegg
D.E.
, Eds.,
Dekker
,
New York
, p. 113,
1981
.
20.
Mazur
,
P.
, “
Freezing of Living Cells: Mechanisms and Implications
.”
American Journal of Physiology
,
1984
, pp. 247–125.
21.
Fahy
,
G.M.
,
Saur
,
J.S.
, and
Williams
,
R.J.
, “
Physical Problems With the Vitrification of Large Biological Systems
,”
Cryobiology
, Vol.
27
,
1990
, pp. 492–510.
22.
Wolfinbarger
,
L.
,
Adam
,
M.
,
Lange
,
P.
,
Hu
,
J.F.
, “
Microfractures in Cryopreserved Heart Valves: Valve Submersion in Liquid Nitrogen Revisited
,”
Applications of Cryogenic Technology, Vol. 10
,
Plenum Press
,
1991
, pp. 227–233.
23.
Kroener
,
C.
and
Luyet
,
B.
, “
Discontinuous Change in Expansion Coefficient at the Glass Transition Temperature in Aqueous Solutions of Glycerol
,”
Biodynamica
, Vol.
10
,
1966
, pp. 41–45.
24.
Kroener
,
C.
and
Luyet
,
B.
, “
Formation of Cracks During the Vitrification of Glycerol Solutions and Disappearance of the Cracks During Rewarming
.”
Biodynamica
, Vol.
10
,
1966
, pp. 47–51.
25.
Rubinsky
,
B.
,
Lee
,
C.
,
Bastacky
,
J.
and
Onik
,
G.
, “
The Process of Freezing in the Liver and the Mechanisms of Damage
.”
Proceedings, CRYO 87, 24th Annual Meeting of the Society for Cryobiology
,
1987
.
26.
Rajotte
,
R.
,
Shnitka
,
T.
,
Liburd
,
E.
,
Dossetor
,
J.
and
Voss
,
W.
, “
Histological Studies on Cultured Canine Heart Valves Recovered From -196°C
.”
Cryobiology
Vol.
14
,
1977
, pp. 15–22.
27.
Baudot
,
A.
,
Boutron
,
P.
, and
Descotes
,
J. L.
, “
Physical Vitrification of Rabbit Aortas Without Any Fracture
,”
Proceedings, CRYO 2001, 38th Annual Meeting of the Society for Cryobiology
,
2001
.
28.
Adam
,
M.
,
Hu
,
J.F.
,
Lange
,
P.
and
Wolfinbarger
,
L.
, “
The Effect of Liquid Nitrogen Submersion on Cryopreserved Human Heart Valves
.”
Cryobiology
, Vol.
27
,
1990
, pp. 605–614.
29.
Whittingham
,
D.G.
,
Leibo
,
S.P.
,
Mazur
,
P.
, “
Survival of Mouse Embryos Frozen to-196°C and -269°C
,”
Science
, Vol.
178
,
1972
, pp. 411–414.
30.
Miller
,
R.H.
, and
Mazur
,
P.
, “
Survival of Frozen—Thawed Human Red Cells as a Function of Cooling and Warming Velocities
,”
Cryobiology
, Vol.
13
,
1976
, pp. 404–414.
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