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Volumn 63, Issue 2, 1999, Pages 166-174

Protein formulation and lyophilization cycle design: Prevention of damage due to freeze-concentration induced phase separation

Author keywords

Cooling rate; Lyophilization; Phase separation; Protein stability; Spray freeze drying

Indexed keywords

ANNEALING; COMPOSITION EFFECTS; CRYSTALLIZATION; DRYING; FOURIER TRANSFORM INFRARED SPECTROSCOPY; FREEZING; NITROGEN; PHASE SEPARATION; REACTION KINETICS; SPRAYING; THERMODYNAMIC STABILITY;

EID: 0033586786     PISSN: 00063592     EISSN: None     Source Type: Journal    
DOI: 10.1002/(SICI)1097-0290(19990420)63:2<166::AID-BIT5>3.0.CO;2-H     Document Type: Article
Times cited : (143)

References (42)
  • 3
    • 0024549238 scopus 로고
    • An infrared spectroscopic study of the interactions of carbohydrates with dried proteins
    • Carpenter JF, Crowe JH. 1989. An infrared spectroscopic study of the 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
  • 4
    • 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
  • 5
    • 0027256589 scopus 로고
    • Separation of freezing-and drying-induced denaturation of lyophilized proteins using stress-specific stabilization. I. Enzyme activity and calorimetric studies
    • Carpenter JF, Prestrelski SJ, Arakawa T. 1993. Separation of freezing-and drying-induced denaturation of lyophilized proteins using stress-specific stabilization. I. Enzyme activity and calorimetric studies. Arch Biochem Biophys 303:456-464.
    • (1993) Arch Biochem Biophys , vol.303 , pp. 456-464
    • Carpenter, J.F.1    Prestrelski, S.J.2    Arakawa, T.3
  • 6
    • 0030443567 scopus 로고    scopus 로고
    • Surface-induced denaturation of proteins during freezing and its inhibition by surfactants
    • Chang B, Kendrick B, Carpenter J. 1996. Surface-induced denaturation of proteins during freezing and its inhibition by surfactants. J Pharm Sci 85:1325-1330.
    • (1996) J Pharm Sci , vol.85 , pp. 1325-1330
    • Chang, B.1    Kendrick, B.2    Carpenter, J.3
  • 7
    • 0004080557 scopus 로고    scopus 로고
    • Princeton, NJ: Princeton University Press
    • Debenedetti PG. 1996. Metastable liquids. Princeton, NJ: Princeton University Press.
    • (1996) Metastable Liquids
    • Debenedetti, P.G.1
  • 8
    • 0028307232 scopus 로고
    • Infrared methods for study of hemoglobin reactions and structures
    • Dong A, Caughey WS. 1994. Infrared methods for study of hemoglobin reactions and structures. Methods Enzymol 232:139-175.
    • (1994) Methods Enzymol , vol.232 , pp. 139-175
    • Dong, A.1    Caughey, W.S.2
  • 9
    • 0025357111 scopus 로고
    • Protein secondary structures in water from second-derivative amide I infrared spectra
    • Dong A, Huang P, Caughey WS. 1990. Protein secondary structures in water from second-derivative amide I infrared spectra. Biochemistry 29:3303-3308.
    • (1990) Biochemistry , vol.29 , pp. 3303-3308
    • Dong, A.1    Huang, P.2    Caughey, W.S.3
  • 10
    • 0017802795 scopus 로고
    • Supercooled water as a medium for enzyme reactions at subzero temperatures
    • Douzou P, Debey P, Franks F. 1978. Supercooled water as a medium for enzyme reactions at subzero temperatures. Biochim Biophys Acta 523: 1-8.
    • (1978) Biochim Biophys Acta , vol.523 , pp. 1-8
    • Douzou, P.1    Debey, P.2    Franks, F.3
  • 11
    • 0000286988 scopus 로고
    • Ion-pairing as indicator for enhanced mobility in the glassy state of hyperquenched solution
    • Fleissner G, Hallbrucker A, Mayer E. 1995. Ion-pairing as indicator for enhanced mobility in the glassy state of hyperquenched solution. J Phys Chem 99:8401-8404.
    • (1995) J Phys Chem , vol.99 , pp. 8401-8404
    • Fleissner, G.1    Hallbrucker, A.2    Mayer, E.3
  • 13
    • 0002228416 scopus 로고
    • Freeze-drying: A combination of physics, chemistry, engineering and economics
    • Franks F. 1992. Freeze-drying: A combination of physics, chemistry, engineering and economics. Jpn J Freezing Drying 38:5-16.
    • (1992) Jpn J Freezing Drying , vol.38 , pp. 5-16
    • Franks, F.1
  • 14
    • 0002398428 scopus 로고
    • Materials science and production of shelf-stable biologicals
    • Franks F, Hatley RHM, Mathias SF. 1991. Materials science and production of shelf-stable biologicals. Biopharmaceuticals 4:38-42.
    • (1991) Biopharmaceuticals , vol.4 , pp. 38-42
    • Franks, F.1    Hatley, R.H.M.2    Mathias, S.F.3
  • 15
    • 0027183176 scopus 로고
    • Determination of the unfrozen water content of maximally freeze-concentrated carbohydrate solutions
    • Hatley RHM, Mant A. 1993. Determination of the unfrozen water content of maximally freeze-concentrated carbohydrate solutions. Int J Biol Macromol 15:227-232.
    • (1993) Int J Biol Macromol , vol.15 , pp. 227-232
    • Hatley, R.H.M.1    Mant, A.2
  • 16
    • 0030443488 scopus 로고    scopus 로고
    • Effects of phase separating systems on lyophilized hemoglobin
    • Heller M, Carpenter J, Randolph T. 1996. Effects of phase separating systems on lyophilized hemoglobin. J Pharm Sci 85:1358-1362.
    • (1996) J Pharm Sci , vol.85 , pp. 1358-1362
    • Heller, M.1    Carpenter, J.2    Randolph, T.3
  • 17
    • 0031239857 scopus 로고    scopus 로고
    • Protein phase separation during freeze-drying: Implications for pharmaceutical proteins
    • Heller M, Carpenter J, Randolph T. 1997a. Protein phase separation during freeze-drying: Implications for pharmaceutical proteins. Biotechnol Prog 13:590-596.
    • (1997) Biotechnol Prog , vol.13 , pp. 590-596
    • Heller, M.1    Carpenter, J.2    Randolph, T.3
  • 18
    • 0031239857 scopus 로고    scopus 로고
    • Manipulation of lyophilization induced phase separation: Implications for pharmaceutical proteins
    • Heller MC, Carpenter JF, Randolph TW. 1997b. Manipulation of lyophilization induced phase separation: Implications for pharmaceutical proteins. Biotechnol Prog 13:590-596.
    • (1997) Biotechnol Prog , vol.13 , pp. 590-596
    • Heller, M.C.1    Carpenter, J.F.2    Randolph, T.W.3
  • 19
    • 0029040644 scopus 로고
    • Electrolyte-induced changes in glass transition temperatures of freeze-concentrated solutes
    • Her L-M, Deras M, Nail SL. 1995. Electrolyte-induced changes in glass transition temperatures of freeze-concentrated solutes. Pharm Res 12: 768-772.
    • (1995) Pharm Res , vol.12 , pp. 768-772
    • Her, L.-M.1    Deras, M.2    Nail, S.L.3
  • 20
    • 0028816797 scopus 로고
    • Surface denaturation at solid-void interface: A possible pathway by which opalescent particulates form during the storage of lyophilized tissue-type plasminogen activator at high temperatures
    • Hsu CC, Nguyen HM, Yeung DA, Brooks DA, Koe DS, Bewley TA, Pearlman R. 1995. Surface denaturation at solid-void interface: A possible pathway by which opalescent particulates form during the storage of lyophilized tissue-type plasminogen activator at high temperatures. Pharm Res 12:69-77.
    • (1995) Pharm Res , vol.12 , pp. 69-77
    • Hsu, C.C.1    Nguyen, H.M.2    Yeung, D.A.3    Brooks, D.A.4    Koe, D.S.5    Bewley, T.A.6    Pearlman, R.7
  • 21
    • 0029020745 scopus 로고
    • Increased stabilizing effects of amphilic excipients on freeze-drying of lactate dehydrogenase (LDH) by dispersion into sugar matrices
    • Izutsu K-i, Yoshioka S, Kojima S. 1995. Increased stabilizing effects of amphilic excipients on freeze-drying of lactate dehydrogenase (LDH) by dispersion into sugar matrices. Pharm Res 12:838-843.
    • (1995) Pharm Res , vol.12 , pp. 838-843
    • Izutsu, K.-I.1    Yoshioka, S.2    Kojima, S.3
  • 22
    • 0029855850 scopus 로고    scopus 로고
    • Effects of sugars and polymers on crystallization of poly(ethylene glycol) in frozen solutions: Phase separation between incompatible polymers
    • Izutsu K-i, Yoshioka S, Kojima S, Randolph TW, Carpenter JF. 1996. Effects of sugars and polymers on crystallization of poly(ethylene glycol) in frozen solutions: Phase separation between incompatible polymers. Pharm Res 13:1393-1400.
    • (1996) Pharm Res , vol.13 , pp. 1393-1400
    • Izutsu, K.-I.1    Yoshioka, S.2    Kojima, S.3    Randolph, T.W.4    Carpenter, J.F.5
  • 23
    • 0028098067 scopus 로고
    • Effect of mannitol crystallinity on the stabilization of enzymes during freeze-drying
    • Izutsu K-i, Yoshioka S, Terao T. 1994. Effect of mannitol crystallinity on the stabilization of enzymes during freeze-drying. Chem Pharm Bull 42:5-8.
    • (1994) Chem Pharm Bull , vol.42 , pp. 5-8
    • Izutsu, K.-I.1    Yoshioka, S.2    Terao, T.3
  • 24
    • 0031660957 scopus 로고    scopus 로고
    • Effects of Tween 80 and sucrose on acute short-term stability and long-term storage at -20°C of a recombinant hemoglobin
    • Kerwin BA, Heller MC, Levin SH, Randolph TW. 1998. Effects of Tween 80 and sucrose on acute short-term stability and long-term storage at -20°C of a recombinant hemoglobin. J Pharm Sci 87(9):1062-1068.
    • (1998) J Pharm Sci , vol.87 , Issue.9 , pp. 1062-1068
    • Kerwin, B.A.1    Heller, M.C.2    Levin, S.H.3    Randolph, T.W.4
  • 26
    • 0014360915 scopus 로고
    • Study by differential thermal analysis of the temperatures of instability of rapidly cooled solutions of glycerol, ethylene glycol, sucrose and glucose
    • Luyet B, Rasmussen DH. 1968. Study by differential thermal analysis of the temperatures of instability of rapidly cooled solutions of glycerol, ethylene glycol, sucrose and glucose. Biodynamica 10:167-191.
    • (1968) Biodynamica , vol.10 , pp. 167-191
    • Luyet, B.1    Rasmussen, D.H.2
  • 27
    • 0001732030 scopus 로고
    • Devitrification in glass-forming aqueous solutions
    • MacFarlane DR. 1986. Devitrification in glass-forming aqueous solutions. Cryobiology 23:230-244.
    • (1986) Cryobiology , vol.23 , pp. 230-244
    • MacFarlane, D.R.1
  • 28
    • 0000012841 scopus 로고
    • Physical aspects of vitrification in aqueous solutions
    • MacFarlane DR. 1987. Physical aspects of vitrification in aqueous solutions. Cryobiology 24:181-195.
    • (1987) Cryobiology , vol.24 , pp. 181-195
    • MacFarlane, D.R.1
  • 29
    • 0025300823 scopus 로고
    • Recent insights on the role of cryoprotective agents in vitrification
    • MacFarlane DR, Forsyth M. 1990. Recent insights on the role of cryoprotective agents in vitrification. Cryobiology 27:345-358.
    • (1990) Cryobiology , vol.27 , pp. 345-358
    • MacFarlane, D.R.1    Forsyth, M.2
  • 30
    • 0017785395 scopus 로고
    • Non-equilibrium freezing behavior of aqueous systems
    • MacKenzie AP. 1977. Non-equilibrium freezing behavior of aqueous systems. Phil Trans R Soc London, Ser B, Biol 278:167-189.
    • (1977) Phil Trans R Soc London, Ser B, Biol , vol.278 , pp. 167-189
    • MacKenzie, A.P.1
  • 32
    • 0030965088 scopus 로고    scopus 로고
    • Use of subambient differential scanning calorimetry to monitor the frozen-state behavior of blends of excipients for freeze-drying
    • Martini A, Kume S, Crivellente M, Artico R. 1997. Use of subambient differential scanning calorimetry to monitor the frozen-state behavior of blends of excipients for freeze-drying. PDA J Pharm Sci Technol 51:62-67.
    • (1997) PDA J Pharm Sci Technol , vol.51 , pp. 62-67
    • Martini, A.1    Kume, S.2    Crivellente, M.3    Artico, R.4
  • 33
    • 36549099427 scopus 로고
    • New method for vitrifying water and other liquids by rapid cooling of their aerosols
    • Mayer E. 1985. New method for vitrifying water and other liquids by rapid cooling of their aerosols. J Appl Phys 58:663-667.
    • (1985) J Appl Phys , vol.58 , pp. 663-667
    • Mayer, E.1
  • 34
    • 0027176042 scopus 로고
    • Separation of freezing-and drying-induced denaturation of lyophilized proteins using stress-specific stabilization. II. Structural studies using infrared spectroscopy
    • Prestrelski SJ, Arakawa T, Carpenter JF. 1993. Separation of freezing-and drying-induced denaturation of lyophilized proteins using stress-specific stabilization. II. Structural studies using infrared spectroscopy. Arch Biochem Biophys 303:465-473.
    • (1993) Arch Biochem Biophys , vol.303 , pp. 465-473
    • Prestrelski, S.J.1    Arakawa, T.2    Carpenter, J.F.3
  • 35
    • 0014893852 scopus 로고
    • Contribution to the establishment of the temperature-concentration curves of homogeneous nucleation in solutions of some cryoprotective agents
    • Rasmussen D, Luyet B. 1970. Contribution to the establishment of the temperature-concentration curves of homogeneous nucleation in solutions of some cryoprotective agents. Biodynamica 11:33-44.
    • (1970) Biodynamica , vol.11 , pp. 33-44
    • Rasmussen, D.1    Luyet, B.2
  • 36
    • 0002739208 scopus 로고
    • Effect of solute on ice-solution interfacial free energy: Calculation from measured homogeneous nucleation temperatures
    • Jellinrk HHG, editor. New York: Plenum
    • Rasmussen DH, MacKenzie AP. 1972. Effect of solute on ice-solution interfacial free energy: Calculation from measured homogeneous nucleation temperatures. In: Jellinrk HHG, editor. Water Structure and the Water-Polymer Interface. New York: Plenum. p 126.
    • (1972) Water Structure and the Water-Polymer Interface , pp. 126
    • Rasmussen, D.H.1    MacKenzie, A.P.2
  • 38
    • 0030043206 scopus 로고    scopus 로고
    • Proteins in frozen solutions: Evidence of ice-induced partial unfolding
    • Strambini GB, Gabellieri E. 1996. Proteins in frozen solutions: Evidence of ice-induced partial unfolding. Biophys J 70:971-976.
    • (1996) Biophys J , vol.70 , pp. 971-976
    • Strambini, G.B.1    Gabellieri, E.2
  • 39
    • 0022463740 scopus 로고
    • Resolution-enhanced Fourier transform infrared spectroscopy of enzymes
    • Susi H, Byler DM. 1986. Resolution-enhanced Fourier transform infrared spectroscopy of enzymes. Methods Enzymol 130:290-311.
    • (1986) Methods Enzymol , vol.130 , pp. 290-311
    • Susi, H.1    Byler, D.M.2
  • 40
    • 0002514501 scopus 로고
    • Critical cooling rates to avoid ice crystallization in aqueous cryoprotectant solutions containing polymers
    • Sutton RL. 1991. Critical cooling rates to avoid ice crystallization in aqueous cryoprotectant solutions containing polymers. J Chem Soc, Faraday Trans 87:3747-3751.
    • (1991) J Chem Soc, Faraday Trans , vol.87 , pp. 3747-3751
    • Sutton, R.L.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.