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Protein Aggregation And Its Inhibition In Biopharmaceutics.

W. Wang
Published 2005 · Chemistry, Medicine

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Protein aggregation is arguably the most common and troubling manifestation of protein instability, encountered in almost all stages of protein drug development. Protein aggregation, along with other physical and/or chemical instabilities of proteins, remains to be one of the major road barriers hindering rapid commercialization of potential protein drug candidates. Although a variety of methods have been used/designed to prevent/inhibit protein aggregation, the end results are often unsatisfactory for many proteins. The limited success is partly due to our lack of a clear understanding of the protein aggregation process. This article intends to discuss protein aggregation and its related mechanisms, methods characterizing protein aggregation, factors affecting protein aggregation, and possible venues in aggregation prevention/inhibition in various stages of protein drug development.
This paper references
10.1023/A:1025771421906
Physical Stability of Proteins in Aqueous Solution: Mechanism and Driving Forces in Nonnative Protein Aggregation
Eva Y. Chi (2004)
10.1023/A:1018951530927
Aggregates Formed During Storage of β-Galactosidase in Solution and in the Freeze-Dried State
S. Yoshioka (2004)
10.1023/A:1018893115557
Reversibility of Heat-Induced Denaturation of the Recombinant Human Megakaryocyte Growth and Development Factor
L. Narhi (2004)
10.1021/JS980140V
Effects of Tween 80 and Sucrose on Acute Short-Term Stability and Long-Term Storage at − 20 C of a Recombinant Hemoglobin
B. Kerwin (1998)
10.1002/JPS.2600831202
Approaches to analysis of aggregates and demonstrating mass balance in pharmaceutical protein (basic fibroblast growth factor) formulations.
Z. Shahrokh (1994)
The formulation of recombinant factor IX: stability, robustness, and convenience.
L. Bush (1998)
10.1006/JMBI.2001.4845
Protein refolding versus aggregation: computer simulations on an intermediate-resolution protein model.
A. V. Smith (2001)
10.1016/0014-4835(90)90137-J
In vitro non-enzymatic glycation and formation of browning products in the bovine lens alpha-crystallin.
J. Liang (1990)
10.1111/j.1423-0410.1995.tb02535.x
Thermal Stability of Human Immunoglobulins with Sorbitol: A Critical Evaluation
M. González (1995)
Enhanced stability of two model proteins in an agitated solution environment using poloxamer 407.
P. L. Wang (1993)
10.1021/BI990510+
Water-soluble beta-sheet models which self-assemble into fibrillar structures.
K. Janek (1999)
10.1002/(SICI)1097-0290(19980805)59:3<281::AID-BIT3>3.0.CO;2-7
II. Electrostatic effect in the aggregation of heat-denatured RNase A and implications for protein additive design.
A. M. Tsai (1998)
10.1023/A:1015959604616
The Effects of Formulation Additives on the Degradation of Freeze-Dried Ribonuclease A
M. W. Townsend (2004)
10.1007/978-1-4899-1236-7_9
Formulation and Stability of Recombinant α 1 -Antitrypsin
S. Vemuri (1993)
10.1248/CPB.45.525
Varying effects of cyclodextrin derivatives on aggregation and thermal behavior of insulin in aqueous solution.
K. Tokihiro (1997)
10.1016/S0092-8674(00)80143-9
For Protein Misassembly, It's the “I” Decade
R. Wetzel (1996)
10.1002/BIT.260480513
Approaches for increasing the solution stability of proteins.
M. Manning (1995)
10.1021/BI00046A016
Effects of a naturally occurring compatible osmolyte on the internal dynamics of ribonuclease A.
A. Wang (1995)
10.1006/JMBI.1997.1538
Thermodynamic stability and folding of GroEL minichaperones.
R. Golbik (1998)
10.1016/S0076-6879(99)09019-9
Analysis of protein aggregation kinetics.
F. Ferrone (1999)
Stability of rhbFGF as determined by UV spectroscopic measurements of turbidity.
G. Eberlein (1994)
10.1128/AEM.61.4.1220-1225.1995
Protein aggregation kinetics in an Escherichia coli strain overexpressing a Salmonella typhimurium CheY mutant gene.
J. Klein (1995)
10.1021/BC9901189
Synthesis and characterization of poly(ethylene glycol)-insulin conjugates.
K. Hinds (2000)
10.1021/JS9800127
Moisture effects on protein-excipient interactions in spray-dried powders. Nature of destabilizing effects of sucrose.
S. Tzannis (1999)
10.1002/(SICI)1097-0290(19970505)54:3<221::AID-BIT3>3.0.CO;2-H
Oxidative renaturation of lysozyme at high concentrations.
D. Hevehan (1997)
Pharmaceutics of protein drugs.
R. Pearlman (1992)
10.1038/NBT0992-1013
Polyethylene Glycol Enhanced Protein Refolding
J. Cleland (1992)
10.1006/BBRC.1997.6863
β-Helical Fibrils from a Model Peptide
N. Lazo (1997)
10.1006/ABBI.1996.0337
Polymers protect lactate dehydrogenase during freeze-drying by inhibiting dissociation in the frozen state.
T. Anchordoquy (1996)
10.1016/0167-4838(88)90080-5
Kinetics of adsorption of proteins at interfaces: role of protein conformation in diffusional adsorption.
S. Damodaran (1988)
10.1016/S0076-6879(99)09017-5
Inhibition of aggregation side reactions during in vitro protein folding.
E. De Bernardez Clark (1999)
10.1016/S1359-0278(98)00002-9
Protein aggregation: folding aggregates, inclusion bodies and amyloid.
A. Fink (1998)
10.1021/JS980221R
Acute and long-term stability studies of deoxy hemoglobin and characterization of ascorbate-induced modifications.
B. Kerwin (1999)
10.1006/BBRC.1999.1667
An FT-IR study of the beta-amyloid conformation: standardization of aggregation grade.
Z. Szabó (1999)
10.1021/JS9800679
Effect of mannitol crystallization on the stability and aerosol performance of a spray-dried pharmaceutical protein, recombinant humanized anti-IgE monoclonal antibody.
H. Costantino (1998)
10.1111/J.1470-8744.1997.TB01322.X
Applications of site‐specific chemical modification in the manufacture of biopharmaceuticals: I. An overview
R. Lundblad (1997)
10.1016/0003-9861(92)90735-F
Kinetics of aggregation of synthetic β-amyloid peptide
S. J. Tomski (1992)
10.1023/A:1016286600229
Stability of Protein Formulations: Investigation of Surfactant Effects by a Novel EPR Spectroscopic Technique
N. Bam (2004)
10.1007/s00109-003-0464-5
Protein aggregation and aggregate toxicity: new insights into protein folding, misfolding diseases and biological evolution
M. Stefani (2003)
10.1016/S0021-9673(96)01020-5
Studies of the hydrodynamic volume changes that occur during refolding of lysozyme using size-exclusion chromatography.
B. Batas (1997)
10.1006/JMBI.1999.3039
An NMR investigation of solution aggregation reactions preceding the misassembly of acid-denatured cold shock protein A into fibrils.
A. Alexandrescu (1999)
10.1021/bp960068b
Molten Globule Intermediate of Recombinant Human Growth Hormone: Stabilization with Surfactants
N. Bam (1996)
10.1021/J100189A013
Theory for the aggregation of proteins and copolymers
G. Fields (1992)
10.1074/JBC.274.23.16077
Identification of amino acid residues critical for aggregation of human CC chemokines macrophage inflammatory protein (MIP)-1alpha, MIP-1beta, and RANTES. Characterization of active disaggregated chemokine variants.
L. Czaplewski (1999)
Aggregation of insulin and its prevention by carbohydrate excipients.
M. Katakam (1995)
10.1089/cmb.1999.6.143
Lattice Simulations of Aggregation Funnels for Protein Folding
S. Istrail (1999)
10.1002/JPS.20014
Raman spectroscopic characterization of drying-induced structural changes in a therapeutic antibody: correlating structural changes with long-term stability.
Samir U. Sane (2004)
10.1002/JPS.2600840609
Effect of surfactants on the physical stability of recombinant human growth hormone.
M. Katakam (1995)
10.1023/A:1018919508463
Lyophilized Formulations of Recombinant Tumor Necrosis Factor
M. Hora (2004)
10.1093/emboj/18.17.4794
The oxidative refolding of hen lysozyme and its catalysis by protein disulfide isomerase
B. van den Berg (1999)
10.1002/PRO.5560040811
Control of aggregation in protein refolding: A variety of surfactants promote renaturation of carbonic anhydrase II
D. Wetlaufer (1995)
10.1016/S0141-8130(99)00060-4
Structural investigation of β-lactoglobulin gelation in ethanol/water solutions
D. Renard (1999)
10.1023/A:1015834724528
The Effects of Formulation Variables on the Stability of Freeze-Dried Human Growth Hormone
M. Pikal (2004)
10.1023/A:1011974512425
Structural and Functional Differences Between Glycosylated and Non-glycosylated Forms of Human Interferon-β (IFN-β)
L. Runkel (2004)
10.1021/BI00017A009
Comparing the refolding and reoxidation of recombinant porcine growth hormone from a urea denatured state and from Escherichia coli inclusion bodies.
M. Cardamone (1995)
10.1093/PROTEIN/6.7.733
Breakdown in the relationship between thermal and thermodynamic stability in an interleukin-1 beta point mutant modified in a surface loop.
B. Chrunyk (1993)
10.1002/BIT.260400805
Mechanism of insulin aggregation and stabilization in agitated aqueous solutions
V. Sluzky (1992)
10.1021/BI00027A012
NMR study of the cold, heat, and pressure unfolding of ribonuclease A.
J. Zhang (1995)
10.1023/A:1007570030368
Protein Spray-Freeze Drying. Effect of Atomization Conditions on Particle Size and Stability
H. Costantino (2004)
10.1016/S0141-8130(96)01150-6
Destabilization of human serum albumin by polyethylene glycols studied by thermodynamical equilibrium and kinetic approaches.
B. Farruggia (1997)
10.1002/(SICI)1097-0290(19970620)54:6<503::AID-BIT1>3.0.CO;2-N
Protein denaturation by combined effect of shear and air-liquid interface.
Y. Maa (1997)
10.1021/BI982120D
Secondary structure and oligomerization behavior of equilibrium unfolding intermediates of the lambda cro repressor.
H. Fabian (1999)
10.1006/ABBI.1997.0349
Spectroscopic study of secondary structure and thermal denaturation of recombinant human factor XIII in aqueous solution.
A. Dong (1997)
10.1016/S0378-5173(97)00155-5
Recombinant factor VIII SQ—influence of oxygen, metal ions, pH and ionic strength on its stability in aqueous solution
A. Fatouros (1997)
10.1002/(SICI)1097-0134(19990215)34:3<356::AID-PROT8>3.0.CO;2-O
Effect of amino acid substitutions at the subunit interface on the stability and aggregation properties of a dimeric protein: Role of Arg 178 and Arg 218 at the dimer interface of thymidylate synthase
V. Prasanna (1999)
10.1074/JBC.270.7.3063
The -Helical to -Strand Transition in the Amino-terminal Fragment of the Amyloid -Peptide Modulates Amyloid Formation *
C. Soto (1995)
10.1073/PNAS.88.21.9377
Kinetics of insulin aggregation in aqueous solutions upon agitation in the presence of hydrophobic surfaces.
V. Sluzky (1991)
10.1016/S0958-1669(98)80109-2
Refolding of recombinant proteins
Clark (1998)
10.1006/ABBI.1998.0948
Effects of additives on the stability of recombinant human factor XIII during freeze-drying and storage in the dried solid.
L. Kreilgaard (1998)
10.1016/S0141-8130(98)00008-7
Protein stability function relations: beta-lactoglobulin-A sulphydryl group reactivity and its relationship to protein unfolding stability.
R. K. Apenten (1998)
10.1159/000462877
Thermal Stability of Human Immunoglobulins with Sorbitol
M. Gonzalez (1995)
10.1038/NBT0396-329
Improved Refolding of an Immobilized Fusion Protein
G. Stempfer (1996)
10.1002/JPS.2600840407
Infrared spectroscopic studies of lyophilization- and temperature-induced protein aggregation.
A. Dong (1995)
10.1038/NBT0490-308
Solubility as a Function of Protein Structure and Solvent Components
C. Schein (1990)
10.1021/JS960148+
The secondary structure and aggregation of lyophilized tetanus toxoid.
H. Costantino (1996)
10.1023/A:1015851228163
Stability of Interleukin 1β (IL-1β) in Aqueous Solution: Analytical Methods, Kinetics, Products, and Solution Formulation Implications
L. Gu (2004)
10.1002/(SICI)1097-0290(19970520)54:4<333::AID-BIT6>3.0.CO;2-L
Polymerization mechanism of polypeptide chain aggregation.
M. Speed (1997)
10.1016/S0065-3233(08)60197-7
Protein hydration and function.
J. Rupley (1991)
10.1016/S0006-3495(93)81120-2
Dehydration-induced conformational transitions in proteins and their inhibition by stabilizers.
S. Prestrelski (1993)
10.1016/S0958-1669(97)80060-2
Protein folding pathways and intermediates
A. Clarke (1997)
10.1016/S0022-2836(95)80060-3
Domain structure, stability and domain-domain interactions in recombinant factor XIII.
I. V. Kurochkin (1995)
10.1002/PRO.5560060405
The kinetic basis for the stabilization of staphylococcal nuclease by xylose
K. Frye (1997)
10.1111/J.1432-1033.1994.00883.X
A model for the denaturation and aggregation of beta-lactoglobulin.
S. Roefs (1994)
10.1038/NBT0595-493
Aggregation of a Lyophilized Pharmaceutical Protein, Recombinant Human Albumin: Effect of Moisture and Stabilization by Excipients
H. Costantino (1995)
10.1093/PROTEIN/9.1.95
Effective renaturation of denatured and reduced immunoglobulin G in vitro without assistance of chaperone.
Y. Maeda (1996)
10.1021/BI00164A008
Amyloid fibril formation requires a chemically discriminating nucleation event: studies of an amyloidogenic sequence from the bacterial protein OsmB.
J. Jarrett (1992)
10.1016/S0065-3233(08)60656-7
Control of protein stability and reactions by weakly interacting cosolvents: the simplicity of the complicated.
S. N. Timasheff (1998)
10.1016/S0168-3659(98)00148-5
Stabilization of proteins against methylene chloride/water interface-induced denaturation and aggregation.
H. Sah (1999)
10.1006/BBRC.1996.1413
Inhibition of Alzheimer's amyloidosis by peptides that prevent beta-sheet conformation.
C. Soto (1996)
10.1002/PRO.5560031107
Folding and aggregation of TEM β‐lactamase: Analogies with the formation of inclusion bodies in Escherichia coli
G. Georgiou (1994)
10.1007/0-306-47452-2_2
Characterization, stability, and formulations of basic fibroblast growth factor.
Y. Wang (1996)
10.1023/A:1022535701279
High-Pressure Effects on Vacuolar H+-ATPase from Etiolated Mung Bean Seedlings
Y. Tsai (1998)
10.1002/JPS.10587
Optimizing storage stability of lyophilized recombinant human interleukin-11 with disaccharide/hydroxyethyl starch mixtures.
W. Garzon-Rodriguez (2004)
10.1023/A:1015888704365
Effect of Freezing on Aggregation of Human Growth Hormone
B. M. Eckhardt (2004)
10.1002/PRO.5560071218
Effect of denaturant and protein concentrations upon protein refolding and aggregation: A simple lattice model
P. Gupta (1998)
10.1023/A:1016219000963
A New Strategy for Enhancing the Stability of Lyophilized Protein: The Effect of the Reconstitution Medium on Keratinocyte Growth Factor
M. Zhang (2004)
10.1023/A:1016043114998
Development of a Stable Freeze-dried Formulation of Recombinant Human Interleukin-1 Receptor Antagonist
B. Chang (2004)
10.1016/S0006-3495(94)80922-1
Simulations of kinetically irreversible protein aggregate structure.
S. Patro (1994)
10.1023/A:1018935420680
Thermal Stability of Low Molecular Weight Urokinase During Heat Treatment. II. Effect of Polymeric Additives
M. Vrkljan (2004)
Characterization methods for the physical stability of biopharmaceuticals.
L. Nguyen (2003)
10.2174/1389201023378229
The stability factor: importance in formulation development.
R. Krishnamurthy (2002)
10.1023/A:1018805232453
The Effect of Formulation Excipients on Protein Stability and Aerosol Performance of Spray-Dried Powders of a Recombinant Humanized Anti-IgE Monoclonal Antibody1
J. Andya (2004)
10.1023/A:1018962732067
Major Degradation Products of Basic Fibroblast Growth Factor: Detection of Succinimide and Iso-aspartate in Place of Aspartate15
Z. Shahrokh (2004)
10.1271/BBB.60.1757
Fractal analysis of aggregates formed by heating dilute BSA solutions using light scattering methods.
T. Hagiwara (1996)
10.1007/BF02785589
Molecular chaperones, folding catalysts, and the recovery of active recombinant proteins fromE. coli
J. G. Thomas (1997)
10.3168/JDS.S0022-0302(90)79065-0
Comparison of Solute-Induced Protein Stabilization in Aqueous Solution and in the Frozen and Dried States
J. F. Carpenter (1990)
10.1002/JPS.10033
A new mechanism for decreasing aggregation of recombinant human interferon-gamma by a surfactant: slowed dissolution of lyophilized formulations in a solution containing 0.03% polysorbate 20.
S. D. Webb (2002)
10.1016/J.EJPS.2003.12.010
Effects of sucrose on rFVIIa aggregation and methionine oxidation.
S. Soenderkaer (2004)
10.1016/S0014-5793(97)01240-4
Effect of the chaperone‐like alpha‐crystallin on the refolding of lysozyme and ribonuclease A
B. Raman (1997)
10.1016/S0378-5173(99)00288-4
Stabilization of insulin against agitation-induced aggregation by the GMO cubic phase gel.
Y. Sadhale (1999)
10.1093/PROTEIN/8.1.81
Engineered turns of a recombinant antibody improve its in vivo folding.
A. Knappik (1995)
10.1126/SCIENCE.7701317
Biopreservation. Putting proteins under glass.
K. Fox (1995)
10.1006/ABBI.1993.1005
Physical stabilization of acidic fibroblast growth factor by polyanions.
D. Volkin (1993)
10.1023/A:1011961923870
Self-Association Properties of Monomeric Insulin Analogs Under Formulation Conditions
J. P. Richards (2004)
10.1016/0022-2836(92)90699-K
Molecular basis of co-operativity in protein folding. III. Structural identification of cooperative folding units and folding intermediates.
K. P. Murphy (1992)
10.1007/978-3-0348-9127-1_3
Chemical pathways of the Maillard reaction.
F. Ledl (1989)
10.1002/JPS.10334
Effects of annealing lyophilized and spray-lyophilized formulations of recombinant human interferon-gamma.
S. D. Webb (2003)
10.1006/ABIO.1996.0345
Size-exclusion chromatography with on-line light-scattering, absorbance, and refractive index detectors for studying proteins and their interactions.
J. Wen (1996)
10.1021/JS960080Y
Surface-induced denaturation of proteins during freezing and its inhibition by surfactants.
B. Chang (1996)
10.1016/S0076-6879(99)09029-1
Monitoring protein assembly using quasielastic light scattering spectroscopy.
A. Lomakin (1999)
10.1021/BI0105983
Probing the mechanism of insulin fibril formation with insulin mutants.
L. Nielsen (2001)
10.1002/BIT.10448
Effect of rate of chemical or thermal renaturation on refolding and aggregation of a simple lattice protein.
H. Nguyen (2002)
10.1002/JPS.10219
Stabilization of proteins by low molecular weight multi-ions.
Donald S Maclean (2002)
10.1271/bbb.66.880
Salts and Glycine Increase Reversibility and Decrease Aggregation during Thermal Unfolding of Ribonuclease-A
Y. Kita (2002)
10.1002/(SICI)1520-6017(200005)89:5<646::AID-JPS10>3.0.CO;2-J
Protection of bovine serum albumin from aggregation by Tween 80.
T. Arakawa (2000)
10.1074/jbc.274.26.18589
Formation of Fibrous Aggregates from a Non-native Intermediate: The Isolated P22 Tailspike β-Helix Domain*
B. Schuler (1999)
10.1021/MA970113B
Heat-Induced Gelation of Globular Proteins. 2. Effect of Environmental Factors on Single-Component and Mixed-Protein Gels
A. Tobitani (1997)
10.1021/JS980399D
Effects of additives on the stability of Humicola lanuginosa lipase during freeze-drying and storage in the dried solid.
L. Kreilgaard (1999)
10.1111/j.2042-7158.1994.tb03774.x
The Aggregation of Bovine Serum Albumin in Solution and in the Solid State
G. Jordan (1994)
10.1093/PROTEIN/9.3.265
Analysis of protein conformational characteristics related to thermostability.
E. Querol (1996)
10.1110/PS.8.1.161
Association of partially‐folded intermediates of staphylococcal nuclease induces structure and stability
Vladimir N. Uversky (1999)
10.1021/bp9800438
Effect of Additives on Refolding of a Denatured Protein
M. Yasuda (1998)
10.1023/A:1011993620177
A Solid-State NMR Study of Protein Hydration and Stability
F. Separovic (2004)
10.1016/0022-2836(91)90505-Z
Molecular basis of co-operativity in protein folding.
E. Freire (1991)
10.1002/1520-6017(200101)90:1<29::AID-JPS4>3.0.CO;2-4
Studies of the structure of insulin fibrils by Fourier transform infrared (FTIR) spectroscopy and electron microscopy.
L. Nielsen (2001)
10.1007/0-306-47452-2_3
The characterization, stabilization, and formulation of acidic fibroblast growth factor.
D. Volkin (1996)
10.1016/S0378-5173(99)00152-0
Instability, stabilization, and formulation of liquid protein pharmaceuticals.
W. Wang (1999)
10.1073/PNAS.96.18.9989
Amyloid diseases: abnormal protein aggregation in neurodegeneration.
E. Koo (1999)
10.1038/NBT1096-1231
The specificity of protein aggregation
J. Yon (1996)
10.1093/OXFORDJOURNALS.JBCHEM.A124994
Correlation among secondary structure, amyloid precursor protein accumulation, and neurotoxicity of amyloid beta(25-35) peptide as analyzed by single alanine substitution.
K. Sato (1995)
10.1002/JPS.2600840108
Physical stabilization of insulin by glycosylation.
Miroslav Baudyš (1995)
10.3109/10837459709022619
Use of poloxamer polymers to stabilize recombinant human growth hormone against various processing stresses.
M. Katakam (1997)
10.1023/A:1013054431517
Effect of Moisture on the Stability of a Lyophilized Humanized Monoclonal Antibody Formulation
E. Breen (2004)
10.1021/js980126i
Effect of Tween 20 on freeze-thawing- and agitation-induced aggregation of recombinant human factor XIII.
L. Kreilgaard (1998)
10.1016/S0378-5173(00)00423-3
Lyophilization and development of solid protein pharmaceuticals.
W. Wang (2000)
10.1006/jmbi.1998.2246
Global analysis of the effects of temperature and denaturant on the folding and unfolding kinetics of the N-terminal domain of the protein L9.
B. Kuhlman (1998)
10.1006/JMBI.1997.0930
Salt effects on protein stability: two-stranded alpha-helical coiled-coils containing inter- or intrahelical ion pairs.
W. Kohn (1997)
10.1021/JS9700311
Solid-state stability of human insulin. II. Effect of water on reactive intermediate partitioning in lyophiles from pH 2-5 solutions: stabilization against covalent dimer formation.
R. Strickley (1997)
10.1111/J.1432-1033.1997.T01-2-00684.X
Pathway of detergent-mediated and peptide ligand-mediated refolding of heterodimeric class II major histocompatibility complex (MHC) molecules.
J. Stöckel (1997)
10.1021/BI991503O
Protein folding as a diffusional process.
M. Jacob (1999)
10.1002/PRO.5560050314
Control of aggregation in protein refolding: The temperature‐leap tactic
Y. Xie (1996)
10.1021/JS980273G
Influence of calcium ions on the structure and stability of recombinant human deoxyribonuclease I in the aqueous and lyophilized states.
B. Chen (1999)
10.1021/JS980383N
Effects of buffer composition and processing conditions on aggregation of bovine IgG during freeze-drying.
J. M. Sarciaux (1999)
10.1016/S0378-5173(99)00218-5
Stabilization of aerosolized IFN-γ by liposomes
E. Kanaoka (1999)
10.1073/PNAS.94.22.11917
Preferential exclusion of sucrose from recombinant interleukin-1 receptor antagonist: role in restricted conformational mobility and compaction of native state.
B. Kendrick (1997)
10.1073/PNAS.94.20.10636
Protein folding kinetics exhibit an Arrhenius temperature dependence when corrected for the temperature dependence of protein stability.
M. Scalley (1997)
10.1211/0022357991772574
Stability Study of Human Serum Albumin Pharmaceutical Preparations
A. Oliva (1999)
10.1073/PNAS.92.24.11234
Stabilization of tetanus and diphtheria toxoids against moisture-induced aggregation.
S. Schwendeman (1995)
10.1002/JPS.2600831205
Solid-phase aggregation of proteins under pharmaceutically relevant conditions.
H. Costantino (1994)
10.1016/S0006-3495(96)79400-6
Counteracting effects of thiocyanate and sucrose on chymotrypsinogen secondary structure and aggregation during freezing, drying, and rehydration.
S. D. Allison (1996)
10.1023/A:1015825027737
Protein–Solvent Interactions in Pharmaceutical Formulations
T. Arakawa (2004)
10.1080/15216549900201473
Protein folding as a nonlinear nonequilibrium thermodynamic process
E. Popov (1999)
10.1021/BI00435A044
An infrared spectroscopic study of the interactions of carbohydrates with dried proteins.
J. Carpenter (1989)
10.1074/JBC.271.7.3478
Artificial Chaperone-assisted Refolding of Carbonic Anhydrase B
D. Rozema (1996)
10.1021/BI9730137
High hydrostatic pressure can reverse aggregation of protein folding intermediates and facilitate acquisition of native structure.
B. Gorovits (1998)
10.1073/PNAS.94.25.13520
Correct protein folding in glycerol.
R. V. Rariy (1997)
10.1093/emboj/18.24.6927
Effects of macromolecular crowding on protein folding and aggregation
B. van den Berg (1999)
10.1023/A:1015108115452
Inverse Relationship of Protein Concentration and Aggregation
M. Treuheit (2004)
10.1016/0731-7085(93)80128-N
Conformation of human calcitonin gene-related peptide (8-37) in aqueous solution as determined by circular dichroism spectroscopy.
J. Matsuura (1993)
10.1073/pnas.95.24.14142
A transient expansion of the native state precedes aggregation of recombinant human interferon-gamma.
B. Kendrick (1998)
10.1007/s00726-003-0014-z
Dityrosine as a product of oxidative stress and fluorescent probe
D. Malencik (2003)
10.1016/S0196-9781(02)00061-X
Imaging real-time aggregation of amyloid beta protein (1–42) by atomic force microscopy
A. Parbhu (2002)
10.1023/A:1018905720139
Aggregation Pathway of Recombinant Human Keratinocyte Growth Factor and Its Stabilization
B. Chen (2004)
10.1006/JMBI.1997.1146
An exceptionally stable helix from the ribosomal protein L9: implications for protein folding and stability.
B. Kuhlman (1997)
10.1023/A:1016286920643
The Effect of pH and Temperature on the Self-Association of Recombinant Human Interleukin-2 as Studied by Equilibrium Sedimentation
Siddharth J. Advant (2004)
10.1006/ABBI.1996.0305
Physical factors affecting the storage stability of freeze-dried interleukin-1 receptor antagonist: glass transition and protein conformation.
B. Chang (1996)
Strategies for stabilising tetanus toxoid towards the development of a single-dose tetanus vaccine.
S. Schwendeman (1996)
10.1021/BI982739F
Aggregation and assembly of phage P22 temperature-sensitive coat protein mutants in vitro mimic the in vivo phenotype.
C. Teschke (1999)
10.1006/ABBI.1998.0751
The Mechanism of α1-Antitrypsin Polymerization Probed by Fluorescence Spectroscopy
E. L. James (1998)
10.1021/JF00084A007
Formation of intermolecular .beta.-sheet structure during heat denaturation of ovalbumin
A. Kato (1988)
10.1073/PNAS.94.15.7942
Kinetic theory of fibrillogenesis of amyloid β-protein
A. Lomakin (1997)
10.1023/A:1016270103863
Surface Denaturation at Solid-Void Interface—A Possible Pathway by Which Opalescent Participates Form During the Storage of Lyophilized Tissue-Type Plasminogen Activator at High Temperatures
C. Hsu (2004)
10.1016/0378-3812(93)87148-T
Theory for protein solubilities
D. Stigter (1993)
10.3109/10837459809009861
Effects of formulation and process variables on the aggregation of freeze-dried interleukin-6 (IL-6) after lyophilization and on storage.
B. Lueckel (1998)
The effects of formulation and moisture on the stability of a freeze-dried monoclonal antibody-vinca conjugate: a test of the WLF glass transition theory.
Roy Ml (1992)
10.1016/S0168-3659(02)00488-1
Poly(ethylene glycol) as stabilizer and emulsifying agent: a novel stabilization approach preventing aggregation and inactivation of proteins upon encapsulation in bioerodible polyester microspheres.
I. J. Castellanos (2003)
10.1016/S0076-6879(99)09018-7
Inhibition of stress-induced aggregation of protein therapeutics.
J. Carpenter (1999)
10.1021/BI00502A009
Refolding and aggregation of bovine carbonic anhydrase B: quasi-elastic light scattering analysis.
J. Cleland (1990)
10.1002/JPS.2600841013
Stability of recombinant consensus interferon to air-jet and ultrasonic nebulization.
A. Ip (1995)
10.1021/BI00017A008
Aggregation and precipitation of human relaxin induced by metal-catalyzed oxidation.
S. Li (1995)
10.1021/BI9924720
Evidence for the involvement of histidine A(12) in the aggregation and precipitation of human relaxin induced by metal-catalyzed oxidation.
M. Khossravi (2000)
10.1016/S0141-8130(99)00107-5
Factors affecting the dissociation and aggregation of human interferon gamma.
T. Zlateva (1999)
10.1023/A:1007015416572
Advanced glycation end products in human senile and diabetic cataractous lenses
S. Zarina (2004)
10.1021/BI012006M
Aggregation of granulocyte colony stimulating factor under physiological conditions: characterization and thermodynamic inhibition.
S. Krishnan (2002)
10.1021/BI001782B
Partially folded intermediates as critical precursors of light chain amyloid fibrils and amorphous aggregates.
R. Khurana (2001)
10.1042/BA20030038
l‐Tyrosine prevents aggregation of therapeutic proteins by γ‐irradiation
Emma Assemand (2003)
10.1016/S0031-6865(96)00049-0
Degradation pathways, analytical characterization and formulation strategies of a peptide and a protein. Calcitonine and human growth hormone in comparison.
M. Cholewinski (1996)
Development of a lyophilized formulation of interleukin-2.
M. Hora (1992)
10.1021/BI961638J
Artificial chaperone-assisted refolding of denatured-reduced lysozyme: modulation of the competition between renaturation and aggregation.
D. Rozema (1996)
10.1006/JMBI.1996.0148
Specificity of abnormal assembly in immunoglobulin light chain deposition disease and amyloidosis.
L. R. Helms (1996)
10.1021/BI00193A027
Scrapie amyloid (prion) protein has the conformational characteristics of an aggregated molten globule folding intermediate.
J. Šafář (1994)
10.1074/jbc.274.46.32897
Structural Mapping of an Aggregation Nucleation Site in a Molten Globule Intermediate*
P. Hammarström (1999)
10.1023/A:1018981208076
Moisture-Induced Aggregation of Lyophilized Insulin
H. Costantino (2004)
10.1021/JS980175V
Tween protects recombinant human growth hormone against agitation-induced damage via hydrophobic interactions.
N. Bam (1998)
10.1021/JS9801384
Aggregation of recombinant human interferon gamma: kinetics and structural transitions.
B. Kendrick (1998)
10.1021/BI991518M
Aggregation events occur prior to stable intermediate formation during refolding of interleukin 1beta.
J. Finke (2000)
10.1006/CYTO.1997.0228
Recombinant human IL-2 is cytotoxic to oligodendrocytes after in vitro self aggregation.
L. Curatolo (1997)
10.1016/0167-4838(95)00156-O
Fourier-transform infrared spectroscopic investigation of protein stability in the lyophilized form.
H. Costantino (1995)
10.1002/JPS.2600840303
Evidence for a common intermediate in insulin deamidation and covalent dimer formation: effects of pH and aniline trapping in dilute acidic solutions.
R. Darrington (1995)
10.1023/A:1015887001987
Chemical Stability of Insulin. 2. Formation of Higher Molecular Weight Transformation Products During Storage of Pharmaceutical Preparations
J. Brange (2004)
10.1006/BBRC.1995.1778
Cyclodextrins as protein folding aids.
N. Karuppiah (1995)
10.1002/BIT.260370210
Moisture‐induced aggregation of lyophilized proteins in the solid state
W. Liu (1991)
10.1093/PROTEIN/9.5.461
Effect of additives on the renaturation of reduced lysozyme in the presence of 4 M urea.
Y. Maeda (1996)
10.1111/j.2042-7158.1992.tb05472.x
Enhancement of the stability of thrombin by polyols: microcalorimetric studies
A. Boctor (1992)
10.1023/A:1018994102218
Techniques for Assessing the Effects of Pharmaceutical Excipients on the Aggregation of Porcine Growth Hormone
S. Charman (2004)
10.1021/BI030135S
Relative influence of hydrophobicity and net charge in the aggregation of two homologous proteins.
M. Calamai (2003)
10.1002/JPS.10135
Surface adsorption of recombinant human interferon-gamma in lyophilized and spray-lyophilized formulations.
S. D. Webb (2002)
10.1023/A:1013334916162
In Situ Study of Insulin Aggregation Induced by Water-Organic Solvent Interface
Y. M. Kwon (2004)
10.1016/S0378-5173(98)00038-6
Stabilizers against heat-induced aggregation of RPR 114849, an acidic fibroblast growth factor (aFGF)
C. M. Won (1998)
10.1016/S0006-3495(00)76602-1
The thermal stability of immunoglobulin: unfolding and aggregation of a multi-domain protein.
A. Vermeer (2000)
10.1006/BBRC.1996.1364
Folding pathway of human alpha 1-antitrypsin: characterization of an intermediate that is active but prone to aggregation.
D. Kim (1996)
10.1016/S0006-3495(93)81312-2
Light scattering analysis of fibril growth from the amino-terminal fragment beta(1-28) of beta-amyloid peptide.
C. Shen (1993)
10.1016/S0141-8130(97)01159-8
DSC studies on bovine serum albumin denaturation. Effects of ionic strength and SDS concentration.
C. Giancola (1997)
10.1002/(SICI)1097-0290(20000220)67:4<457::AID-BIT9>3.0.CO;2-K
Supercritical fluid precipitation of recombinant human immunoglobulin from aqueous solutions.
D. Nesta (2000)
10.1016/J.BBRC.2003.11.055
Solubilization of active green fluorescent protein from insoluble particles by guanidine and arginine.
K. Tsumoto (2003)
10.1002/(SICI)1097-0290(19980805)59:3<273::AID-BIT2>3.0.CO;2-8
I. Study of protein aggregation due to heat denaturation: A structural approach using circular dichroism spectroscopy, nuclear magnetic resonance, and static light scattering.
A. M. Tsai (1998)
10.1023/A:1018939228201
Formulation Design of Acidic Fibroblast Growth Factor
P. Tsai (2004)
10.1016/S0006-291X(03)00578-3
The effects of arginine on refolding of aggregated proteins: not facilitate refolding, but suppress aggregation.
T. Arakawa (2003)
10.1016/0141-0229(84)90034-6
Structure-stability relationships in proteins: new approaches to stabilizing enzymes
V. Mozhaev (1984)
10.1016/S0076-6879(99)09005-9
Isolating inclusion bodies from bacteria.
G. Georgiou (1999)
10.1023/A:1012180707283
Rational Design of Stable Lyophilized Protein Formulations: Some Practical Advice
J. Carpenter (2004)
10.1038/NBT0394-253
Long–Term Stabilization of Biologicals
F. Franks (1994)
10.1006/JMBI.1994.1704
Conformation and fibrillogenesis of Alzheimer A beta peptides with selected substitution of charged residues.
P. Fraser (1994)
10.1021/BI00066A006
Aggregation and denaturation of apomyoglobin in aqueous urea solutions.
L. R. De Young (1993)
10.1038/NBT0697-514
Refolding with a piece of the ring
J. King (1997)
10.1021/JS960297S
Toward understanding insulin fibrillation.
J. Brange (1997)
10.1038/385787A0
Instability, unfolding and aggregation of human lysozyme variants underlying amyloid fibrillogenesis
D. Booth (1997)
10.1042/BJ3140701
The conformation of Alzheimer's beta peptide determines the rate of amyloid formation and its resistance to proteolysis.
C. Soto (1996)
10.1021/BP00014A002
Transient Association of the First Intermediate during the Refolding of Bovine Carbonic Anhydrase B
J. Cleland (1992)



This paper is referenced by
10.1002/jps.22633
Predicting accelerated aggregation rates for monoclonal antibody formulations, and challenges for low-temperature predictions.
R. K. Brummitt (2011)
10.1201/9781420004137.ch17
Excipients for Protein Drugs
Y. Gokarn (2006)
10.3109/9781420086447-6
Biopharmaceutics of NCEs and NBEs
B. Agoram (2016)
10.1074/jbc.M605984200
A Role for Protein Misfolding in Immunogenicity of Biopharmaceuticals*
C. Maas (2007)
10.1016/J.SEPPUR.2009.10.002
Continuous fractionation of plasma proteins HSA and HIgG using cascade ultrafiltration systems
M. Mayani (2009)
10.1039/c3cp44564j
Single-molecule assays for investigating protein misfolding and aggregation.
A. Hoffmann (2013)
Synergistic Effects of Interfaces and Agitation on Particle Formation in Therapeutic Protein Formulations in Pre-Filled Syringes
Alana Gerhardt (2014)
Investigations on protein adsorption to coated glass vials
Kerstin Hoeger (2014)
10.1371/JOURNAL.PBIO.0050134
A Helical Structural Nucleus Is the Primary Elongating Unit of Insulin Amyloid Fibrils
B. Vestergaard (2007)
10.1038/s41598-018-37072-x
Isothermal Analysis of ThermoFluor Data can readily provide Quantitative Binding Affinities
Nan Bai (2018)
10.1073/pnas.2007036117
Defining principles that influence antimicrobial peptide activity against capsulated Klebsiella pneumoniae
Renee M Fleeman (2020)
10.1002/btpr.2289
Cell culture media impact on drug product solution stability
J. Purdie (2016)
10.1016/j.ab.2010.02.001
Strategies to increase the reproducibility of protein fibrillization in plate reader assays.
L. Giehm (2010)
10.1016/j.jchromb.2010.02.003
Investigation of degradation processes in IgG1 monoclonal antibodies by limited proteolysis coupled with weak cation-exchange HPLC.
Hollis Lau (2010)
10.22099/MBRC.2013.1820
The Effect of pH on Recombinant C-terminal Domain of Botulinum Neurotoxin Type E (rBoNT/E-HCC)
S. J. Mousavy (2013)
10.1016/j.ijpharm.2015.10.082
Particle contamination of parenteralia and in-line filtration of proteinaceous drugs.
B. P. Werner (2015)
10.1007/s12272-014-0521-3
Effects of thermal and mechanical stress on the physical stability of human growth hormone and epidermal growth factor
J. Y. Lim (2015)
10.1371/journal.pone.0183427
Alternative vaccine administration by powder injection: Needle-free dermal delivery of the glycoconjugate meningococcal group Y vaccine
Nikolas T Weissmueller (2017)
Biotechnology and Bioengineering
V. D. Gregorio (2019)
10.1002/bit.27212
Synergistic effects of flow and interfaces on antibody aggregation
Fulvio Grigolato (2019)
10.1007/s11095-020-02859-z
Formulation and Administration of Biological Medicinal Products”
I. Krämer (2020)
10.1002/9781118449066.CH13
13. Biotechnological Products
D. Bohrer (2012)
Permeation of excised intestinal tissue by insulin released from Eudragit® L100/Trimethyl chitosan chloride microspheres
E. Marais (2013)
Monoclonal antibody (mAb) purification by counter current chromatography (CCC)
S. Fernando (2011)
10.1021/jp3058096
How strongly does trehalose interact with lysozyme in the solid state? Insights from molecular dynamics simulation and inelastic neutron scattering.
A. Lerbret (2012)
10.7763/IJCEA.2014.V5.424
Aggregation Kinetics for Monoclonal Antibody Products
I. Arora (2014)
10.1016/j.ejpb.2009.11.005
Relevant shaking stress conditions for antibody preformulation development.
Annette Eppler (2010)
10.1016/j.ejpb.2013.03.015
Influence of methionine oxidation on the aggregation of recombinant human growth hormone.
Filippo Mulinacci (2013)
Biophysics of protein misfolding
V. Subramaniam (2007)
10.1002/JPS.21209
The effect of cyclodextrins on chemical and physical stability of glucagon and characterization of glucagon/gamma-CD inclusion complexes.
L. Matilainen (2008)
Protein stability in shear flow
Innocent B. Bekard (2010)
PA-IIL as a model lectin for the structural and functional characterisation of related lectins
Aileen Creavin (2010)
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