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Volumn 98, Issue 9, 2009, Pages 3072-3087

Freeze-dry microscopy of protein/sugar mixtures: Drying behavior, interpretation of collapse temperatures and a comparison to corresponding glass transition data

Author keywords

Collapse temperature; Freeze dry microscopy; Glass transition temperature; Proteins

Indexed keywords

BOVINE SERUM ALBUMIN; HUMAN SERUM ALBUMIN; SUCROSE; TREHALOSE;

EID: 68949109864     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.21586     Document Type: Article
Times cited : (104)

References (53)
  • 1
    • 33847115952 scopus 로고    scopus 로고
    • Freeze Drying
    • Swarbrick J, Boylan JC, series editors. New York: Marcel Dekker
    • Pikal MJ. 2002. Freeze Drying. In: Swarbrick J, Boylan JC, series editors. Encyclopaedia of Pharmaceutical Technology. New York: Marcel Dekker. pp 1299-1326.
    • (2002) Encyclopaedia of Pharmaceutical Technology , pp. 1299-1326
    • Pikal, M.J.1
  • 2
    • 28244432903 scopus 로고    scopus 로고
    • Lyophilization of biopharmaceuticals
    • Borchard RT, Middaught CR, series editors. Arlington, VA: AAPS Press. ISBN: 0-9711767-6-0
    • Pikal MJ, Costantino HR. 2004. Lyophilization of biopharmaceuticals. In: Borchard RT, Middaught CR, series editors. Biotechnology: Pharmaceutical aspects, Vol.II. Arlington, VA: AAPS Press. ISBN: 0-9711767-6-0.
    • (2004) Biotechnology: Pharmaceutical Aspects , vol.2
    • Pikal, M.J.1    Costantino, H.R.2
  • 3
    • 2942722679 scopus 로고    scopus 로고
    • Antibodies and genetically engineered related molecules: Production and purification
    • Roque ACA, Lowe CR, Taipa MA. 2004. Antibodies and genetically engineered related molecules: Production and purification. Biotechnol Prog 20:639-654.
    • (2004) Biotechnol Prog , vol.20 , pp. 639-654
    • Roque, A.C.A.1    Lowe, C.R.2    Taipa, M.A.3
  • 4
    • 14844285410 scopus 로고    scopus 로고
    • The therapeutic antibodies market to 2008
    • Pavlou AK, Belsey MJ. 2005. The therapeutic antibodies market to 2008. Eur J Pharm Biopharm 59:389-396.
    • (2005) Eur J Pharm Biopharm , vol.59 , pp. 389-396
    • Pavlou, A.K.1    Belsey, M.J.2
  • 6
    • 0030770631 scopus 로고    scopus 로고
    • Rational design of stable lyophilized protein formulations: Some practical advice
    • Carpenter JF, Pikal MJ, Chang BS, Randolph TW. 1997. Rational design of stable lyophilized protein formulations: Some practical advice. Pharm Res 14:969-975.
    • (1997) Pharm Res , vol.14 , pp. 969-975
    • Carpenter, J.F.1    Pikal, M.J.2    Chang, B.S.3    Randolph, T.W.4
  • 7
    • 0001904754 scopus 로고
    • Freeze-drying of proteins. Part II: Formulation selection
    • Pikal MJ. 1990. Freeze-drying of proteins. Part II: Formulation selection. Bio Pharm 3:26-29.
    • (1990) Bio Pharm , vol.3 , pp. 26-29
    • Pikal, M.J.1
  • 8
    • 35748979712 scopus 로고    scopus 로고
    • Protein stability during freezing: Separation of stresses and mechanisms of protein stabilization
    • Bhatnagar BS, Bogner RH, Pikal MJ. 2007. Protein stability during freezing: Separation of stresses and mechanisms of protein stabilization. Pharm Dev Technol 12:505-523.
    • (2007) Pharm Dev Technol , vol.12 , pp. 505-523
    • Bhatnagar, B.S.1    Bogner, R.H.2    Pikal, M.J.3
  • 9
    • 0034255393 scopus 로고    scopus 로고
    • Lyophilization and development of solid protein pharmaceuticals
    • DOI 10.1016/S0378-5173(00)00423-3, PII S0378517300004233
    • Wang W. 2000. Lyophilization and development of solid protein pharmaceuticals. Int J Pharm 203:1-60. (Pubitemid 30627625)
    • (2000) International Journal of Pharmaceutics , vol.203 , Issue.1-2 , pp. 1-60
    • Wang, W.1
  • 11
    • 55449104956 scopus 로고    scopus 로고
    • Mechanisms of aggregate formation and carbohydrate excipient stabilization of lyophilized humanized monoclonal antibody formulations
    • Article 10
    • Andaya JD, Hsu CC, Shire SJ. 2003. Mechanisms of aggregate formation and carbohydrate excipient stabilization of lyophilized humanized monoclonal antibody formulations. AAPS Pharm Sci 5:94-104. Article 10.
    • (2003) AAPS Pharm Sci , vol.5 , pp. 94-104
    • Andaya, J.D.1    Hsu, C.C.2    Shire, S.J.3
  • 13
    • 2642550862 scopus 로고    scopus 로고
    • Challenges in the development of high protein concentration formulations
    • DOI 10.1002/jps.20079
    • Shire SJ, Shahrokh Z, Liu J. 2004. Challenges in the development of high protein concentration formulations. J Pharm Sci 93:1390-1402. (Pubitemid 38725014)
    • (2004) Journal of Pharmaceutical Sciences , vol.93 , Issue.6 , pp. 1390-1402
    • Shire, S.J.1    Shahrokh, Z.2    Liu, J.3
  • 14
    • 0001844127 scopus 로고
    • Freeze drying: From empiricism to predictability
    • Franks F. 1990. Freeze drying: From empiricism to predictability. Cryo-Letters 11:93-110.
    • (1990) Cryo-Letters , vol.11 , pp. 93-110
    • Franks, F.1
  • 15
    • 0001332667 scopus 로고
    • Freeze-drying: Principles and practice
    • Avis KE, Lieberman HA, Lechman L, editors. New York: Marcel Dekker
    • Nail SL, Gatlin LA. 1993. Freeze-drying: Principles and practice. In: Avis KE, Lieberman HA, Lechman L, editors. Pharmaceutical dosage forms: Parenteral medications, Vol.2. New York: Marcel Dekker. pp 163-233.
    • (1993) Pharmaceutical Dosage Forms: Parenteral Medications , vol.2 , pp. 163-233
    • Nail, S.L.1    Gatlin, L.A.2
  • 16
    • 0032078241 scopus 로고    scopus 로고
    • Freeze-drying of bioproducts: Putting principles into practice
    • DOI 10.1016/S0939-6411(98)00004-6, PII S0939641198000046
    • Franks F. 1998. Freeze-drying of bioproducts: Putting principles into practice. Eur J Pharm Biopharm 45:221-229. (Pubitemid 28270810)
    • (1998) European Journal of Pharmaceutics and Biopharmaceutics , vol.45 , Issue.3 , pp. 221-229
    • Franks, F.1
  • 18
    • 1242314686 scopus 로고    scopus 로고
    • Design of Freeze-Drying Processes for Pharmaceuticals: Practical Advice
    • DOI 10.1023/B:PHAM.0000016234.73023.75
    • Tang X, Pikal MJ. 2004. Design of freeze-drying processes for pharmaceuticals: Practical advice. Pharm Res 21:191-200. (Pubitemid 38221965)
    • (2004) Pharmaceutical Research , vol.21 , Issue.2 , pp. 191-200
    • Tang, X.1    Pikal, M.J.2
  • 19
    • 0025006471 scopus 로고
    • The collapse temperature in freeze drying: Dependence on measurement methodology and rate of water removal from the glassy phase
    • DOI 10.1016/0378-5173(90)90231-R
    • Pikal MJ, Shah S. 1990. The collapse temperature in freeze drying: Dependence on measurement methodology and rate of water removal from the glassy phase. Int J Pharm 62:165-186. (Pubitemid 20261787)
    • (1990) International Journal of Pharmaceutics , vol.62 , Issue.2-3 , pp. 165-186
    • Pikal, M.J.1    Shah, S.2
  • 22
    • 0027435684 scopus 로고
    • Stabilization of lyophilized porcine pancreatic elastase
    • Chang BS, Randall CS, Lee YS. 1993. Stabilization of lyophilized porcine pancreatic elastase. Pharm Res 10:1478-1483.
    • (1993) Pharm Res , vol.10 , pp. 1478-1483
    • Chang, B.S.1    Randall, C.S.2    Lee, Y.S.3
  • 23
    • 0032190182 scopus 로고    scopus 로고
    • Effects of drying methods and additives on structure and function of actin: Mechanisms of dehydration-induced damage and its inhibition
    • DOI 10.1006/abbi.1998.0832
    • Allison SD, Randolph TW, Manning MC, Middleton K, Davis A, Carpenter JF. 1998. Effects of drying methods and additives on structure and function of actin: Mechanisms of dehydration-induced damage and its inhibition. Arch Biochem Biophys 358:171-181. (Pubitemid 28471387)
    • (1998) Archives of Biochemistry and Biophysics , vol.358 , Issue.1 , pp. 171-181
    • Allison, S.D.1    Randolph, T.W.2    Manning, M.C.3    Middleton, K.4    Davis, A.5    Carpenter, J.F.6
  • 25
    • 33644983601 scopus 로고    scopus 로고
    • Physical characterization of pharmaceutical formulations in frozen and freeze-dried solid states: Techniques and applications in freeze-drying development
    • Liu J. 2006. Physical characterization of pharmaceutical formulations in frozen and freeze-dried solid states: Techniques and applications in freeze-drying development. Pharm Dev Technol 11:3-28.
    • (2006) Pharm Dev Technol , vol.11 , pp. 3-28
    • Liu, J.1
  • 27
    • 33644974907 scopus 로고    scopus 로고
    • Analytical tools for characterization of frozen systems in the development of freeze-dried pharmaceuticals
    • Nail SL, Schwegman JJ, Kamp V. 2000. Analytical tools for characterization of frozen systems in the development of freeze-dried pharmaceuticals. Am Pharm Rev 3:17-25.
    • (2000) Am Pharm Rev , vol.3 , pp. 17-25
    • Nail, S.L.1    Schwegman, J.J.2    Kamp, V.3
  • 28
    • 0031613850 scopus 로고    scopus 로고
    • Investigations of the sub-ambient transitions in frozen sucrose by Modulated Differential Scanning Calorimetry (MDSC)
    • Aubuchon SR, Thomas LC, Theuerl W, Renner H. 1998. Investigation of the sub-ambient transitions in frozen sucrose by modulated differential scanning calorimetry (MDSC). J Therm Anal 52:53-64. (Pubitemid 128511447)
    • (1998) Journal of Thermal Analysis and Calorimetry , vol.52 , Issue.1 , pp. 53-64
    • Aubuchon, S.R.1    Thomas, L.C.2    Theuerl, W.3    Renner, H.4
  • 29
    • 33646349201 scopus 로고    scopus 로고
    • Using modulated DSC to investigate the origin of multiple thermal transitions in frozen 10% sucrose solutions
    • DOI 10.1016/j.tca.2006.03.006, PII S0040603106001663
    • Chang L, Milton N, Rigsbee D, Mishra DS, Tang X, Thomas LC, Pikal MJ. 2006. Using modulated DSC to investigate the origin of multiple thermal transitions in frozen 10% sucrose solutions. Thermochim Acta 444:141-147. (Pubitemid 43668422)
    • (2006) Thermochimica Acta , vol.444 , Issue.2 , pp. 141-147
    • Chang, L.1    Milton, N.2    Rigsbee, D.3    Mishra, D.S.4    Tang, X.5    Thomas, L.C.6    Pikal, M.J.7
  • 30
    • 37049075919 scopus 로고
    • Structural glass transitions and thermophysical processes in amorphous carbohydrates and their super-saturated solutions
    • Shalaev EY, Franks F. 1995. Structural glass transitions and thermophysical processes in amorphous carbohydrates and their super-saturated solutions. J Chem Soc Faraday Trans 91:1511-1517.
    • (1995) J Chem Soc Faraday Trans , vol.91 , pp. 1511-1517
    • Shalaev, E.Y.1    Franks, F.2
  • 31
    • 0031835707 scopus 로고    scopus 로고
    • Characterization of the sucrose/glycine/water system by differential scanning calorimetry and freeze-drying microscopy
    • Kasraian K, Spitznagel TM, Juneau JA, Yim K. 1998. Characterization of the sucrose/glycine system by differential scanning calorimetry and freeze-drying microscopy. Pharm Dev Technol 3:233-239. (Pubitemid 28310939)
    • (1998) Pharmaceutical Development and Technology , vol.3 , Issue.2 , pp. 233-239
    • Kasraian, K.1    Spitznagel, T.M.2    Juneau, J.A.3    Yim, K.4
  • 32
    • 0021836493 scopus 로고
    • Use of laboratory data in freeze drying process design: Heat and mass transfer coefficients and the computer simulation of freeze drying
    • Pikal MJ. 1995. Use of laboratory data in freeze drying process design: Heat and mass transfer coefficients and the computer simulation of freeze drying. J Parent Sci Technol 39:115-138.
    • (1995) J Parent Sci Technol , vol.39 , pp. 115-138
    • Pikal, M.J.1
  • 33
    • 0030638567 scopus 로고    scopus 로고
    • Characteristics and Significance of the Amorphous State in Pharmaceutical Systems
    • Hancock BC, Zografi G. 1997. Characteristics and significance of the amorphous state in pharmaceutical systems. J Pharm Sci 86:1-12. (Pubitemid 127489650)
    • (1997) Journal of Pharmaceutical Sciences , vol.86 , Issue.1
    • Hancock, B.C.1    Zografi, G.2
  • 35
    • 1142269554 scopus 로고    scopus 로고
    • Collapse Temperature of Freeze-Dried Lactobacillus bulgaricus Suspensions and Protective Media
    • DOI 10.1021/bp034136n
    • Fonseca F, Passot S, Cunin O, Marin M. 2004. Collapse temperature of freeze-dried lactobacillus bulgaricus suspensions and protective media. Biotechnol Prog 20:229-238. (Pubitemid 38204193)
    • (2004) Biotechnology Progress , vol.20 , Issue.1 , pp. 229-238
    • Fonseca, F.1    Passot, S.2    Cunin, O.3    Marin, M.4
  • 36
    • 68949106578 scopus 로고    scopus 로고
    • Active standard: ASTM E1356-03, Standard Test Method for Assignment of the Glass Transition Temperatures by Differential Scanning Calorimetry
    • American Society for Testing and Materials. 14.02
    • American Society for Testing and Materials. 2007. Active standard: ASTM E1356-03, Standard Test Method for Assignment of the Glass Transition Temperatures by Differential Scanning Calorimetry. Book of Standards, Vol.14.02.
    • (2007) Book of Standards
  • 37
    • 2542627629 scopus 로고    scopus 로고
    • Elastic behavior of cross-linked and bundled actin networks
    • DOI 10.1126/science.1095087
    • Gardel ML, Shin JH, MacKintosh FC, Mahadevan L, Matsudaira P, Weitz DA. 2004. Elastic behavior of cross-linked and bundled actin networks. Science 304:1301-1305. (Pubitemid 38697422)
    • (2004) Science , vol.304 , Issue.5675 , pp. 1301-1305
    • Gardel, M.L.1    Shin, J.H.2    MacKintosh, F.C.3    Mahadevan, L.4    Matsudaira, P.5    Weitz, D.A.6
  • 38
    • 23144460878 scopus 로고    scopus 로고
    • Heat and mass transfer scale-up issues during freeze drying: II. Control and characterization of the degree of supercooling
    • Article 58
    • Rambhatla S, Ramot R, Bhugra C, Pikal MJ. 2004. Heat and mass transfer scale-up issues during freeze drying: II. Control and characterization of the degree of supercooling. AAPS Pharm SciTech 5:1-9. Article 58.
    • (2004) AAPS Pharm SciTech , vol.5 , pp. 1-9
    • Rambhatla, S.1    Ramot, R.2    Bhugra, C.3    Pikal, M.J.4
  • 39
    • 0020596449 scopus 로고
    • Physical chemistry of freeze-drying: Measurement of sublimation rates for frozen aqueous solutions by a microbalance technique
    • Pikal MJ, Shah S, Senior D, Lang JE. 1983. Physical chemistry of freeze-drying: Measurement of sublimation rates for frozen aqueous solutions by a microbalance technique. J Pharm Sci 72:635-650.
    • (1983) J Pharm Sci , vol.72 , pp. 635-650
    • Pikal, M.J.1    Shah, S.2    Senior, D.3    Lang, J.E.4
  • 40
    • 38149002933 scopus 로고    scopus 로고
    • Use of manometric temperature measurement (MTM) and SMART freeze dryer technology for development of an optimized freeze-drying cycle
    • Gieseler H, Kramer T, Pikal MJ. 2007. Use of manometric temperature measurement (MTM) and SMART freeze dryer technology for development of an optimized freeze-drying cycle. J Pharm Sci 96:3402-3418.
    • (2007) J Pharm Sci , vol.96 , pp. 3402-3418
    • Gieseler, H.1    Kramer, T.2    Pikal, M.J.3
  • 41
    • 34447580430 scopus 로고    scopus 로고
    • PAT for freeze drying: Cycle optimization in the laboratory
    • Gieseler H. 2007. PAT for freeze drying: Cycle optimization in the laboratory. Eur Pharm Rev 1:62-67.
    • (2007) Eur Pharm Rev , vol.1 , pp. 62-67
    • Gieseler, H.1
  • 43
    • 0000245766 scopus 로고
    • Modes of stabilization of a protein by organic solutes during desiccation
    • Carpenter JF, Crowe JH. 1988. Modes of stabilization of a protein by organic solutes during desiccation. Cryobiology 25:459-470.
    • (1988) Cryobiology , vol.25 , pp. 459-470
    • Carpenter, J.F.1    Crowe, J.H.2
  • 44
    • 0024549238 scopus 로고
    • An infrared spectroscopic study of interactions of carbohydrates with dried proteins
    • Carpenter JF, Crowe JH. 1989. An infrared spectroscopic study of interactions of carbohydrates with dried proteins. Biochemistry 28:3916-3922.
    • (1989) Biochemistry , vol.28 , pp. 3916-3922
    • Carpenter, J.F.1    Crowe, J.H.2
  • 45
  • 46
    • 0032543119 scopus 로고    scopus 로고
    • Water sorption behavior of lyophilized protein-sugar systems and implications for solid-state interactions
    • DOI 10.1016/S0378-5173(98)00050-7, PII S0378517398000507
    • Costantino HR, Gurley JG, Wu S, Hsu CC. 1998. Water sorption of lyophilized protein-sugar systems and implications for solid-state interactions. Int J Pharm 166:211-221. (Pubitemid 28255228)
    • (1998) International Journal of Pharmaceutics , vol.166 , Issue.2 , pp. 211-221
    • Costantino, H.R.1    Curley, J.G.2    Wu, S.3    Hsu, C.C.4
  • 47
    • 0001610230 scopus 로고
    • The adsorption of water by proteins
    • Pauling L. 1945. The adsorption of water by proteins. J Am Chem Soc 67:555-557.
    • (1945) J Am Chem Soc , vol.67 , pp. 555-557
    • Pauling, L.1
  • 48
    • 15144356720 scopus 로고
    • The adsorption of water vapor on casein
    • Green RW. 1948. The adsorption of water vapor on casein. Trans R Soc N Z 77:313-317.
    • (1948) Trans R Soc N Z , vol.77 , pp. 313-317
    • Green, R.W.1
  • 50
    • 0028268210 scopus 로고
    • The relationship between the glass transition temperature and the water content of amorphous pharmaceutical solids
    • DOI 10.1023/A:1018941810744
    • Hancock BC, Zografi G. 1994. The relationship between the glass transition temperature and the water content of amorphous pharmaceutical solids. Pharm Res 11:471-477. (Pubitemid 24144434)
    • (1994) Pharmaceutical Research , vol.11 , Issue.4 , pp. 471-477
    • Hancock, B.C.1    Zografi, G.2
  • 51
    • 0028029152 scopus 로고
    • Measurement of glass transition temperatures of freeze-concentrated solutes by differential scanning calorimetry
    • Her LM, Nail SL. 1994. Measurement of glass transition temperatures of freeze-concentrated solutes by differential scanning calorimetry. Pharm Res 11:54-59.
    • (1994) Pharm Res , vol.11 , pp. 54-59
    • Her, L.M.1    Nail, S.L.2
  • 52
    • 39749167336 scopus 로고    scopus 로고
    • Characterization of amorphous solids with weak glass transitions using high ramp rate differential scanning calorimetry
    • DOI 10.1002/jps.20991
    • Katayama DS, Carpenter JF, Manning MC, Randolph TW, Setlow P, Menard KP. 2008. Characterization of amorphous solids with weak glass transitions using high ramp rate differential scanning calorimetry. J Pharm Sci 97:1013-1024. (Pubitemid 351293899)
    • (2008) Journal of Pharmaceutical Sciences , vol.97 , Issue.2 , pp. 1013-1024
    • Katayama, D.S.1    Carpenter, J.F.2    Manning, M.C.3    Randolph, T.W.4    Setlow, P.5    Menard, K.P.6
  • 53
    • 0000818501 scopus 로고
    • Use of subambient thermal analysis to optimize protein lyophilization
    • Chang BS, Randall CS. 1992. Use of subambient thermal analysis to optimize protein lyophilization. Cryobiology 29:632-656.
    • (1992) Cryobiology , vol.29 , pp. 632-656
    • Chang, B.S.1    Randall, C.S.2


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