Cryopreservation and Freeze-Drying Protocols, Second Edition

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34 Adams 1. Temperature. Whereas a freeze-dried product is more shelf stable than its solution counterpart, freeze-dried materials are sensitive to thermal decay and will be influenced by storage temperature (45). 2. Moisture content (46–53). 3. Reactive gases (54). 4. Light. 5. Free radical damage (55). 6. Background nuclear radiation. 7. Specific chemical reactions including Maillard reactions (56). The interrelationship between sample formulation, dried cake moisture cake, storage conditions, and glass transition temperature (Tg) are complex. In general terms, any physical distortion of the dry cake during storage will often result in a much more rapid loss of sample activity than predicted using the Arrhenius equation for reviewing similar samples (21,29,32,33,57–59). 7.1. Influence of Suspending Medium Composition on Survival of Live Cells to Freeze-Drying Attempts to freeze-dry cells in water or a simple salt solution typically result in poor survival. A wide range of protective media has been developed for preserving freeze-dried vaccines, including augmented growth media or sugar solutions. Carbohydrates are widely used as freeze-drying protectants either individually or in combination with other solutes. They should be chosen on the basis of experimentally determining their freeze-drying characteristics rather than on a pragmatic basis. Monosaccharides, such as glucose, provide good bioprotection during freezing and freeze-drying but exhibit low glass transition (Tg′) or collapse temperatures (Tc) and dry with collapse when orthodox freezedrying cycles are used. Disaccharides are effective freeze-drying protectants, and because they display higher collapse than monosaccharides, freeze-dry successfully when conventional drying cycles are used. Reducing sugars may induce damaging Maillard reactions, thereby compromising stability, and for this reason nonreducing disaccharides, such as sucrose or trehalose, are preferred to reducing sugars such as lactose (62). The addition of salts to formulations containing sugars will markedly depress Tg′ or Tc. (1,3,20,23,31,58,60). Although presenting technical difficulties such as sample collapse, during freeze-drying the amorphous phase may be an essential prerequisite for stabilizing biomaterials, such as vaccines and live cells, by providing an integration of the protective additive, and biomolecule thereby minimizing damage level during freeze-drying and drying. It is not possible in a review of this length to provide anything other than an overview of freeze-drying relevant to the freeze-drying of labile biomolecules and both inactivated or attenuated vaccines. In producing this chapter, the
Principles of Freeze-Drying 35 author nevertheless has attempted to examine all aspects of freeze-drying, because even a basic understanding of this complex technology requires an appreciation of all the factors in the process that can influence the acceptability or unacceptability, safety, and efficacy of the preparation. References 1. Adams, G. D. J. (1995) The preservation of inocula. In: Microbiological Quality Assurance: A Guide Towards Relevance and Reproducibility of Inocula, (Brown, M.R.W and Gilbert, P., eds.), CRC Press, London, UK, pp. 89–119. 2. Fanget, B. and Francon, A. (1996) A Varicella vaccine stable at 5 degrees C. Dev. Biol. Stand. 87, 167–171. 3. Adams, G. D. J. (1996) Lyophilization of vaccines. In: Vaccine Protocols, (Robinson, A., Farrar, G. H., and Wiblin, C. N., eds.), Humana Press, Totowa, NJ, pp. 167–185. 4. Gheorghiu, M., Lagranderie, M., and Balazuc, A. M. (1996) Stabilsation of BCG vaccines Dev. Biol. Stand. 87, 251–261. 5. Bindschaedler, C. (1999) Lyophilization process validation. In: Freeze- Drying/Lyophilization of Pharmaceutical and Biological Products, (Rey, L and May, J. C., eds.), Marcel Dekker, New York, pp. 373–408. 6. Mackenzie, A. P. (1985) A current understanding of the freeze-drying of representative aqueous solutions. In: Refrigeration Science and Technology: Fundamentals and Applications of Freeze-Drying to Biological Materials, Drugs and Foodstuffs. International Institute of Refrigeration, Science et Technique du Froid, Refrigeration Science and Technology, Commission C1, Paris, France, pp. 21–34. 7. Oetjen, G. (1999) Industrial freeze-drying for pharmaceutical applications. In: Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products, (Rey, L and May, J. C., eds.), Marcel Dekker, New York, pp. 267–335. 8. Adams, G. D. J. (1995) Freeze-Drying—The Integrated Approach Pharmaceutical Manufacturing International Published by Sterling Publications Limited, London, UK, pp. 177–180. 9. Carpenter, J. F., Izutsu, K., and Randolph, T. W. (1999) Freezing- and dryinginduced perturbations of protein structure and mechanisms of protein protection by stabilizing additives. In: Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products, (Rey, L and May, J. C., eds.), Marcel Dekker, New York, pp. 123–161. 10. Gheorghiu, M., Lagranderie, M., and Balazuc, A. M. (1996) Stabilsation of BCG vaccines. Dev. Biol. Stand. 87, 251–261. 11. Cammack, K. A. and Adams, G. D. J. (1985) Formulation and storage. In: Animal Cell Biotechnology, vol. 2, (Spiers, R. E. and Griffiths, J. B., eds.), Academic, London, UK, pp. 251–288. 12. Adebayo, A. A., Sim-Brandenburg, J. W., Emmel, H., Olaeye, D. O., Niedrig, M. (1998) Stability of 17D Yellow fever virus vaccine using different stabilisers. Biologicals 26, 309–316.
Page 1: METHODS IN MOLECULAR BIOLOGY 368 C
Page 5: M E T H O D S I N M O L E C U L A R
Page 8 and 9: © 2007 Humana Press Inc. 999 River
Page 11 and 12: Contents Preface ..................
Page 13 and 14: Contributors SUE ARMITAGE • Natio
Page 15 and 16: Glossary of Specialized Terms Cell
Page 17 and 18: 2 Stacey and Day However, such coll
Page 19 and 20: 4 Stacey and Day bank prepared meet
Page 21 and 22: 6 Table 2 Standards for Cell Bankin
Page 23 and 24: 8 Stacey and Day Table 3 Examples o
Page 25 and 26: 10 Table 4 Typical Storage and Tran
Page 27 and 28: 12 Stacey and Day 5. Hebert, P. D.,
Page 29: 14 Stacey and Day 38. Stacey, G. N.
Page 32 and 33: 16 Adams inactivation, and is more
Page 34 and 35: 18 Adams However, freeze-drying is
Page 36 and 37: 20 Adams chambered vials, and prefi
Page 38 and 39: 22 Adams 2.3.1. Shelf-Cooling Rate
Page 40 and 41: 24 Adams Although heat annealing wi
Page 42 and 43: 26 Adams noncrystalline, glass. Whe
Page 44 and 45: 28 Adams system, or (2) isolating t
Page 46 and 47: 30 Adams moisture, is converted int
Page 48 and 49: 32 Adams 4. Reconstituting the Prod
Page 52 and 53: 36 Adams 13. Mackenzie, A. P. (1977
Page 54 and 55: 38 Adams Pharmaceutical and Biologi
Page 56 and 57: 40 Pegg of diffusion and osmosis ha
Page 58 and 59: 42 Pegg Fig. 1. Schematic represent
Page 60 and 61: 44 Pegg Fig. 4. Human erythrocytes
Page 62 and 63: 46 Pegg Fig. 6. Hemolysis observed
Page 64 and 65: 48 Pegg solutes. Biological systems
Page 66 and 67: 50 Pegg reach their final volume. T
Page 68 and 69: 52 Pegg is frozen is outside the sy
Page 70 and 71: 54 Pegg Fig. 10. Diagram constructe
Page 72 and 73: 56 Pegg 5. Pegg, D. E. (1972) Cryob
Page 75 and 76: 4 Lyophilization of Proteins Paul M
Page 77 and 78: Lyophilization of Proteins 61 In or
Page 79 and 80: Lyophilization of Proteins 63 Fig.1
Page 81 and 82: Lyophilization of Proteins 65 A num
Page 83 and 84: Lyophilization of Proteins 67 Fig.
Page 85 and 86: Lyophilization of Proteins 69 Large
Page 87 and 88: Lyophilization of Proteins 71 The t
Page 89 and 90: 5 Vacuum-Drying and Cryopreservatio
Page 91 and 92: Cryopreservation of Prokaryotes 75
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Cryopreservation of Prokaryotes 85
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100 Bond The removed water vapor is
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102 Bond Fig. 1. Centrifuge head wi
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104 Bond Fig. 3. 8. Removal of ampo
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106 Bond 5. Both lyoprotectants lis
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7 Cryopreservation of Yeast Culture
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Cryopreservation of Yeast Cultures
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120 Tan, van Ingen, and Stalpers is
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122 Tan, van Ingen, and Stalpers Ta
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124 Tan, van Ingen, and Stalpers an
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9 Cryopreservation and Freeze-Dryin
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Centrifugal and Shelf Freeze-Drying
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10 Cryopreservation of Microalgae a
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Cryopreservation of Microalgae and
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154 Grout 2. The production of spec
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156 Grout must undergo a similar tr
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158 Grout 9. To recover the cells,
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160 Grout 13. Mohamed, S. V., Sung,
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12 Cryopreservation of Shoot Tips a
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Cryopreservation of Shoot Tips and
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186 Pritchard or other nonconventio
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188 Pritchard Table 1 Examples of S
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190 Pritchard 3.1.2.1. MOIST SEEDS
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192 Pritchard 2. Assume that the mo
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194 Pritchard 4. Manipulation of se
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196 Pritchard (see Note 9). Lipid-r
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198 Pritchard 10. Daws, M. I., Clel
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200 Pritchard 41. Vasquez, N., Sala
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14 Cryopreservation of Fish Sperm E
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Cryopreservation of Fish Sperm 205
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220 Wishart outlined previously. Fu
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222 Wishart pellets that move aroun
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224 Wishart 7. The original method
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16 Cryopreservation of Animal and H
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Animal and Human Cell Lines 229 4.
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Animal and Human Cell Lines 231 equ
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Animal and Human Cell Lines 233 A b
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Animal and Human Cell Lines 235 3.
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17 Cryopreservation of Hematopoieti
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HSC/HPC for Therapeutic Use 239 num
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HSC/HPC for Therapeutic Use 241 26.
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HSC/HPC for Therapeutic Use 247 Tab
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HSC/HPC for Therapeutic Use 249 UCB
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HSC/HPC for Therapeutic Use 251 3.2
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HSC/HPC for Therapeutic Use 253 the
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HSC/HPC for Therapeutic Use 257 (se
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262 Hunt and Timmons Methods for th
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264 Hunt and Timmons straws for ope
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266 Hunt and Timmons 8. Place the v
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268 Hunt and Timmons However, this
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270 Hunt and Timmons 6. Heng, B. C.
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272 Stacey and Dowall tissue by cry
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274 Stacey and Dowall 5. Humidified
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276 Stacey and Dowall 2. Inspect an
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278 Stacey and Dowall liquid nitrog
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280 Stacey and Dowall but to try to
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20 Cryopreservation of Red Blood Ce
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Cryopreservation of RBCs and PLT 28
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304 Curry semen cryopreservation ha
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306 Curry The problems encountered
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308 Curry 4. Notes 1. In some speci
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310 Curry into the liquid nitrogen
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22 Cryopreservation of Mammalian Oo
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Cryopreservation of Mammalian Oocyt
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23 Cryopreservation of Mammalian Em
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Mammalian Embryos 327 Fig. 1. Micro
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Mammalian Embryos 329 requirement t
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Mammalian Embryos 331 3. Methods Th
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Mammalian Embryos 333 7. Initiate t
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Mammalian Embryos 335 4. Notes Some
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Mammalian Embryos 337 numerical ID
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Mammalian Embryos 339 14. Rall, W.
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342 Index microscopic analysis, 229
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344 Index red blood cell cryopreser
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346 Index hydroxyethyl starch-rapid
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METHODS IN MOLECULAR BIOLOGY • 3
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