-
1
-
-
45149102199
-
Storage Consideration As Part of the Formulation Development Program for Biologics
-
Singh SK. Storage Consideration As Part of the Formulation Development Program for Biologics. Amer. Pharmaceut. Rev. 10(3) 2007: 26-33.
-
(2007)
Amer. Pharmaceut. Rev
, vol.10
, Issue.3
, pp. 26-33
-
-
Singh, S.K.1
-
2
-
-
70449712980
-
Best Practices for Formulation and Manufacturing of Biotech Drug Products
-
Singh SK, et al. Best Practices for Formulation and Manufacturing of Biotech Drug Products. BioPharm Int. 22(6) 2009: 32-48.
-
(2009)
BioPharm Int
, vol.22
, Issue.6
, pp. 32-48
-
-
Singh, S.K.1
-
3
-
-
0028925570
-
Protein Destabilization at Low Temperatures
-
Franks F. Protein Destabilization at Low Temperatures. Adv. Protein Chem. 46, 1995: 105-139.
-
(1995)
Adv. Protein Chem
, vol.46
, pp. 105-139
-
-
Franks, F.1
-
4
-
-
0038700496
-
Nucleation of Ice and Its Management in Ecosystems
-
Franks F. Nucleation of Ice and Its Management in Ecosystems. Phil. Trans. Royal Soc. London, A. 361, 2003: 557-574.
-
(2003)
Phil. Trans. Royal Soc. London, A
, vol.361
, pp. 557-574
-
-
Franks, F.1
-
5
-
-
35748979712
-
Protein Stability During Freezing: Separation of Stresses and Mechanisms of Protein Stabilization
-
Bhatnagar B, Bogner RH, Pikal MJ. Protein Stability During Freezing: Separation of Stresses and Mechanisms of Protein Stabilization. Pharm. Dev. Technol. 12, 2007: 505-523.
-
(2007)
Pharm. Dev. Technol
, vol.12
, pp. 505-523
-
-
Bhatnagar, B.1
Bogner, R.H.2
Pikal, M.J.3
-
6
-
-
0016204251
-
Phase Diagram Relationships in Cryobiology
-
Cocks FH, Brower WE. Phase Diagram Relationships in Cryobiology. Cryobiol. 11, 1974: 340-358.
-
(1974)
Cryobiol
, vol.11
, pp. 340-358
-
-
Cocks, F.H.1
Brower, W.E.2
-
7
-
-
0026411964
-
-
Roos Y, Karel M. Applying State Diagrams to Food Processing and Development. Food Technol. 45, 1991: 66-71, 107.
-
Roos Y, Karel M. Applying State Diagrams to Food Processing and Development. Food Technol. 45, 1991: 66-71, 107.
-
-
-
-
8
-
-
0036319970
-
Calculation of the Cg? and Tg? Interaction Point in the State Diagram of Frozen Solutions
-
Matveev YI, Ablett S. Calculation of the Cg? and Tg? Interaction Point in the State Diagram of Frozen Solutions. Food Hydrocoll. 16, 2002: 419-422.
-
(2002)
Food Hydrocoll
, vol.16
, pp. 419-422
-
-
Matveev, Y.I.1
Ablett, S.2
-
9
-
-
0345732482
-
The H2O-NaCl-Sucrose Phase Diagram and Applications in Cryobiology
-
Gayle FW, Cocks FH, Shepard ML. The H2O-NaCl-Sucrose Phase Diagram and Applications in Cryobiology. J. Appl. Chem. Biotechnol. 27, 1977: 599-607.
-
(1977)
J. Appl. Chem. Biotechnol
, vol.27
, pp. 599-607
-
-
Gayle, F.W.1
Cocks, F.H.2
Shepard, M.L.3
-
10
-
-
17444419893
-
The Water to Ice Transition: Implications for Living Cells
-
Fuller BJ, Benson EF, Lane N, Eds. CRC Press: Boca Raton, FL
-
Muldrew K, et al. The Water to Ice Transition: Implications for Living Cells. Life in the Frozen State. Fuller BJ, Benson EF, Lane N, Eds. CRC Press: Boca Raton, FL, 2004: 67-108.
-
(2004)
Life in the Frozen State
, pp. 67-108
-
-
Muldrew, K.1
-
11
-
-
36048943434
-
-
accessed August 2009
-
Chaplin M. Protein Hydration, 2008; www.lsbu.ac.uk/water/protein. html#r1197; accessed August 2009.
-
(2008)
Protein Hydration
-
-
Chaplin, M.1
-
12
-
-
6844241962
-
Real Time In Situ Monitoring of Lysozyme During Lyophilization Using Infrared Spectroscopy: Dehydration Stress in the Presence of Sucrose
-
Remmele RL, Stushnoff C, Carpenter JF. Real Time In Situ Monitoring of Lysozyme During Lyophilization Using Infrared Spectroscopy: Dehydration Stress in the Presence of Sucrose. Pharm. Res. 14, 1997: 1548-1555.
-
(1997)
Pharm. Res
, vol.14
, pp. 1548-1555
-
-
Remmele, R.L.1
Stushnoff, C.2
Carpenter, J.F.3
-
13
-
-
0035981605
-
Thermodynamic Quantities for the Ionization Reaction of Buffers
-
Goldberg RN, Kishore N, Lennen RM. Thermodynamic Quantities for the Ionization Reaction of Buffers. J. Phys. Chem. Ref. Data 31(2) 2002: 231-370.
-
(2002)
J. Phys. Chem. Ref. Data
, vol.31
, Issue.2
, pp. 231-370
-
-
Goldberg, R.N.1
Kishore, N.2
Lennen, R.M.3
-
14
-
-
77953416654
-
-
Larsen SS. Studies on Stability of Drugs in Frozen Systems, VI: The Effect of Freezing upon pH for Buffered Aqueous Solutions. Arch. Pharm. Chemi. Sci. Ed. 1, 1973: 41-53.
-
Larsen SS. Studies on Stability of Drugs in Frozen Systems, VI: The Effect of Freezing upon pH for Buffered Aqueous Solutions. Arch. Pharm. Chemi. Sci. Ed. 1, 1973: 41-53.
-
-
-
-
15
-
-
77953430310
-
Impact of Freezing upon pH of Buffered Solutions and Consequences for Monoclonal Antibody Aggregation
-
submitted
-
Kolhe P, Amend E, Singh SK. Impact of Freezing upon pH of Buffered Solutions and Consequences for Monoclonal Antibody Aggregation. Biotechnol. Prog. 2009: submitted.
-
(2009)
Biotechnol. Prog
-
-
Kolhe, P.1
Amend, E.2
Singh, S.K.3
-
16
-
-
77953438131
-
-
Cromwell M. Opalescence: A Clarifying Case Study. IBC's Fourth Annual BioProcess International European Conference and Exhibition: Vienna, Austria, 21-24 April 2008.
-
Cromwell M. Opalescence: A Clarifying Case Study. IBC's Fourth Annual BioProcess International European Conference and Exhibition: Vienna, Austria, 21-24 April 2008.
-
-
-
-
17
-
-
77953439418
-
Methods for Reducing or Preventing Liquid-Liquid Phase Separation in High Concentration Protein Solutions
-
US patent application /0070230 A1: 2008; www.wipo.int/pctdb/en/wo.jsp?WO= 2007146268
-
Li L, Kantor A, Warne NW. Methods for Reducing or Preventing Liquid-Liquid Phase Separation in High Concentration Protein Solutions. US patent application 2008/0070230 A1: 2008; www.wipo.int/pctdb/en/wo.jsp?WO= 2007146268.
-
(2008)
-
-
Li, L.1
Kantor, A.2
Warne, N.W.3
-
18
-
-
33751552849
-
Liquid-Liquid Phase Separation of Aqueous Lysozyme Solutions: Effects of pH and Salt Identity
-
Taratuta VG, et al. Liquid-Liquid Phase Separation of Aqueous Lysozyme Solutions: Effects of pH and Salt Identity. J. Phys. Chem. 94, 1990: 2140-2144.
-
(1990)
J. Phys. Chem
, vol.94
, pp. 2140-2144
-
-
Taratuta, V.G.1
-
19
-
-
0037172992
-
Liquid-Liquid Separation in Solutions of Normal and Sickle Cell Hemoglobin
-
Galkin O, et al. Liquid-Liquid Separation in Solutions of Normal and Sickle Cell Hemoglobin. Proc. Natl. Acad. Sci. 99, 2002: 8479-8483.
-
(2002)
Proc. Natl. Acad. Sci
, vol.99
, pp. 8479-8483
-
-
Galkin, O.1
-
20
-
-
0023430928
-
Binary Liquid Phase Separation and Critical Phenomena in a Protein/Water Solution
-
Thomson JA, et al. Binary Liquid Phase Separation and Critical Phenomena in a Protein/Water Solution. Proc. Natl. Acad. Sci. 84, 1987: 7079-7083.
-
(1987)
Proc. Natl. Acad. Sci
, vol.84
, pp. 7079-7083
-
-
Thomson, J.A.1
-
21
-
-
33646007703
-
-
Shen VK, et al. Coarse-Grained Strategy for Modeling Protein Stability in Concentrated Solutions, II: Phase Behavior. Biophys. J. 90, 2006: 1949-1960.
-
Shen VK, et al. Coarse-Grained Strategy for Modeling Protein Stability in Concentrated Solutions, II: Phase Behavior. Biophys. J. 90, 2006: 1949-1960.
-
-
-
-
22
-
-
0030043206
-
Proteins in Frozen Solutions: Evidence of Ice-Induced Partial Unfolding
-
Strambini GB, Gabellieri E. Proteins in Frozen Solutions: Evidence of Ice-Induced Partial Unfolding. Biophys. J. 70, 1996: 971-976.
-
(1996)
Biophys. J
, vol.70
, pp. 971-976
-
-
Strambini, G.B.1
Gabellieri, E.2
-
23
-
-
0030443567
-
Surface-Induced Denaturation of Proteins During Freezing and Its Inhibition By Surfactants
-
Chang BS, Kendrick BS, Carpenter JF. Surface-Induced Denaturation of Proteins During Freezing and Its Inhibition By Surfactants. J. Pharm. Sci. 85, 1996: 1325-1330.
-
(1996)
J. Pharm. Sci
, vol.85
, pp. 1325-1330
-
-
Chang, B.S.1
Kendrick, B.S.2
Carpenter, J.F.3
-
24
-
-
33947627702
-
Protein Stability in Ice
-
Strambini GB, Gonnelli M. Protein Stability in Ice. Biophys. J. 92, 2007: 2131-2138.
-
(2007)
Biophys. J
, vol.92
, pp. 2131-2138
-
-
Strambini, G.B.1
Gonnelli, M.2
-
26
-
-
0001571730
-
Stability of Proteins at Subzero Temperatures: Thermodynamics and Some Ecological Consequences
-
Franks F, Hatley RHM. Stability of Proteins at Subzero Temperatures: Thermodynamics and Some Ecological Consequences. Pure Appl. Chem. 63, 1991: 1367-1380.
-
(1991)
Pure Appl. Chem
, vol.63
, pp. 1367-1380
-
-
Franks, F.1
Hatley, R.H.M.2
-
30
-
-
0024456040
-
The Cold-Induced Denaturation of Lactate Dehydrogenase at Sub-Zero Temperatures in the Absence of Perturbants
-
Hatley RHM, Franks F. The Cold-Induced Denaturation of Lactate Dehydrogenase at Sub-Zero Temperatures in the Absence of Perturbants. FEBS Lett. 257, 1989: 171-173.
-
(1989)
FEBS Lett
, vol.257
, pp. 171-173
-
-
Hatley, R.H.M.1
Franks, F.2
-
31
-
-
0008530768
-
Cold Denaturation of Staphylococcal Nuclease
-
Griko YV, et al. Cold Denaturation of Staphylococcal Nuclease. Proc. Natl. Acad. Sci. USA. 85, 1988: 3343-3347.
-
(1988)
Proc. Natl. Acad. Sci. USA
, vol.85
, pp. 3343-3347
-
-
Griko, Y.V.1
-
33
-
-
0035854688
-
Structural Determinants of Cold Adaptation and Stability in a Large Protein
-
D'Amico S, Gerday C, Fellert G. Structural Determinants of Cold Adaptation and Stability in a Large Protein. J. Biol. Chem. 276, 2001: 25791-25796.
-
(2001)
J. Biol. Chem
, vol.276
, pp. 25791-25796
-
-
D'Amico, S.1
Gerday, C.2
Fellert, G.3
-
34
-
-
4344622456
-
Conformational Stability and Thermodynamic Characterization of the Lipoic Acid Bearing Domain of the Human Mitochondrial Branched Chain ?-Ketoacid Dehydrogenase
-
Naik MT, Huang T-H. Conformational Stability and Thermodynamic Characterization of the Lipoic Acid Bearing Domain of the Human Mitochondrial Branched Chain ?-Ketoacid Dehydrogenase. Protein Sci. 13, 2004: 2483-2492.
-
(2004)
Protein Sci
, vol.13
, pp. 2483-2492
-
-
Naik, M.T.1
Huang, T.-H.2
-
35
-
-
23744490027
-
The Effect of Stabilizers and Denaturants on the Cold Denaturation Temperatures of Proteins and Implications for Freeze Drying
-
Tang X, Pikal MJ. The Effect of Stabilizers and Denaturants on the Cold Denaturation Temperatures of Proteins and Implications for Freeze Drying. Pharm. Res. 22, 2005: 1167-1175.
-
(2005)
Pharm. Res
, vol.22
, pp. 1167-1175
-
-
Tang, X.1
Pikal, M.J.2
-
36
-
-
85009900563
-
Glass Transitions and Product Stability: An Overview
-
Schenz TW. Glass Transitions and Product Stability: An Overview. Food Hydrocoll. 9, 1995: 307-315.
-
(1995)
Food Hydrocoll
, vol.9
, pp. 307-315
-
-
Schenz, T.W.1
-
37
-
-
33845410077
-
Sorbitol Crystallization Can Lead to Protein Aggregation in the Frozen State
-
Piedmonte DM, et al. Sorbitol Crystallization Can Lead to Protein Aggregation in the Frozen State. Pharm. Res. 24, 2006: 136-146.
-
(2006)
Pharm. Res
, vol.24
, pp. 136-146
-
-
Piedmonte, D.M.1
-
38
-
-
48549086114
-
Effect of Solution Conditions, Processing Parameters and Container Materials on Aggregation of a Monoclonal Antibody During Freeze Thawing
-
Kueltzo LA, et al. Effect of Solution Conditions, Processing Parameters and Container Materials on Aggregation of a Monoclonal Antibody During Freeze Thawing. J. Pharm. Sci. 97(5) 2008: 1801-1812.
-
(2008)
J. Pharm. Sci
, vol.97
, Issue.5
, pp. 1801-1812
-
-
Kueltzo, L.A.1
-
39
-
-
37049068040
-
Thermomechanical Properties of Small Carbohydrate-Water Glasses and Rubbers: Kinetically Metastable Systems at Sub-Zero Temperatures
-
Levine H, Slade L. Thermomechanical Properties of Small Carbohydrate-Water Glasses and Rubbers: Kinetically Metastable Systems at Sub-Zero Temperatures. J. Chem. Soc. Faraday Trans. I. 84, 1988a: 2619-2633.
-
(1988)
J. Chem. Soc. Faraday Trans. I
, vol.84
, pp. 2619-2633
-
-
Levine, H.1
Slade, L.2
-
40
-
-
0001962269
-
Principles of "Cryostabilization" Technology from Structure/Property Relationships of Carbohydrate/Water Systems: A Review
-
Levine H, Slade L. Principles of "Cryostabilization" Technology from Structure/Property Relationships of Carbohydrate/Water Systems: A Review. Cryolett. 9, 1988b: 21-63.
-
(1988)
Cryolett
, vol.9
, pp. 21-63
-
-
Levine, H.1
Slade, L.2
-
41
-
-
37049085493
-
Differential Scanning Calorimetric Study of Frozen Sucrose and Glycerol Solutions
-
Ablett S, Izzard MJ, Lillford PJ. Differential Scanning Calorimetric Study of Frozen Sucrose and Glycerol Solutions. J. Chem. Soc. Faraday Trans. I. 1992, 789-794.
-
(1992)
J. Chem. Soc. Faraday Trans. I
, pp. 789-794
-
-
Ablett, S.1
Izzard, M.J.2
Lillford, P.J.3
-
42
-
-
0000818501
-
Use of Subambient Thermal Analysis to Optimize Protein Lyophilization
-
Chang BS, Randall CS. Use of Subambient Thermal Analysis to Optimize Protein Lyophilization. Cryobiol. 29, 1992: 632-656.
-
(1992)
Cryobiol
, vol.29
, pp. 632-656
-
-
Chang, B.S.1
Randall, C.S.2
-
43
-
-
33544464424
-
Large-Scale Freezing and Thawing of Biopharmaceutical Products
-
Eds. Interpharm Press: Buffalo Grove, IL
-
Wisniewski R, Wu V. Large-Scale Freezing and Thawing of Biopharmaceutical Products. Biotechnology and Biopharmaceutical Manufacturing, Processing, and Preservation. Avis KE, Wu VL, Eds. Interpharm Press: Buffalo Grove, IL, 1996: 7-59.
-
(1996)
Biotechnology and Biopharmaceutical Manufacturing, Processing, and Preservation
, pp. 7-59
-
-
Wisniewski, R.1
Wu, V.2
-
44
-
-
0022743346
-
The Effects of Cooling Rate on Solid Phase Transitions and Associated Vial Breakage Occurring in Frozen Mannitol Solutions
-
Williams NA, et al. The Effects of Cooling Rate on Solid Phase Transitions and Associated Vial Breakage Occurring in Frozen Mannitol Solutions. PDA J. Parenter. Sci. Technol. 40, 1986: 135-141.
-
(1986)
PDA J. Parenter. Sci. Technol
, vol.40
, pp. 135-141
-
-
Williams, N.A.1
-
45
-
-
34547223487
-
Vial Breakage During Freeze-Drying: Crystallization of Sodium Chloride in Sodium Chloride-Sucrose Frozen Aqueous Solutions
-
Milton N, et al. Vial Breakage During Freeze-Drying: Crystallization of Sodium Chloride in Sodium Chloride-Sucrose Frozen Aqueous Solutions. J. Pharm. Sci. 96, 2007: 1848-1853.
-
(2007)
J. Pharm. Sci
, vol.96
, pp. 1848-1853
-
-
Milton, N.1
-
46
-
-
0023905575
-
The Mechanism of Cryoprotection of Proteins by Solutes
-
Carpenter JF, Crowe JH. The Mechanism of Cryoprotection of Proteins by Solutes. Cryobiol. 25, 1988: 244-255.
-
(1988)
Cryobiol
, vol.25
, pp. 244-255
-
-
Carpenter, J.F.1
Crowe, J.H.2
-
47
-
-
0025732448
-
Protein-Solvent Interactions in Pharmaceutical Formulations
-
Arakawa T, Kita Y, Carpenter JF. Protein-Solvent Interactions in Pharmaceutical Formulations. Pharm. Res. 8, 1991: 285-291.
-
(1991)
Pharm. Res
, vol.8
, pp. 285-291
-
-
Arakawa, T.1
Kita, Y.2
Carpenter, J.F.3
-
48
-
-
0027272126
-
Freeze-Thaw Studies of a Model Protein, Lactate Dehydrogenase, in the Presence of Cryoprotectants
-
Nema S, Avis KE. Freeze-Thaw Studies of a Model Protein, Lactate Dehydrogenase, in the Presence of Cryoprotectants. J. Parenteral Sci. Technol. 47, 1993: 76-83.
-
(1993)
J. Parenteral Sci. Technol
, vol.47
, pp. 76-83
-
-
Nema, S.1
Avis, K.E.2
-
49
-
-
0030770631
-
Rational Design of Stable Lyophilized Protein Formulations: Some Practical Advice
-
Carpenter JF, et al. Rational Design of Stable Lyophilized Protein Formulations: Some Practical Advice. Pharm. Res. 14, 1997: 969-975.
-
(1997)
Pharm. Res
, vol.14
, pp. 969-975
-
-
Carpenter, J.F.1
-
50
-
-
66349137053
-
Synchrotron X-Ray Diffraction Investigation of the Anomalous Behavior of Ice During Freezing of Aqueous Systems
-
Varshney DB, et al. Synchrotron X-Ray Diffraction Investigation of the Anomalous Behavior of Ice During Freezing of Aqueous Systems. J. Phys. Chem. B. Lett. 113, 2009: 6177-6182.
-
(2009)
J. Phys. Chem. B. Lett
, vol.113
, pp. 6177-6182
-
-
Varshney, D.B.1
|