Challenges in the development of high protein concentration formulations.
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[1] Joseph P. Remington,et al. Remington's pharmaceutical sciences , 2016 .
[2] S J Prestrelski,et al. Precipitation of proteins in supercritical carbon dioxide. , 1996, Journal of pharmaceutical sciences.
[3] L. J. Harris,et al. Crystallization of intact monoclonal antibodies , 1995, Proteins.
[4] C. Cantor,et al. Biophysical Chemistry: Part II: Techniques for the Study of Biological Structure and Function , 1980 .
[5] A. Minton. Analytical centrifugation with preparative ultracentrifuges. , 1989, Analytical biochemistry.
[6] Michael J. Pikal,et al. Freeze‐Drying of Proteins. Process, Formulation, and Stability. , 1995 .
[7] J. M. Schurr,et al. Dynamic light scattering of biopolymers and biocolloids. , 1977, CRC critical reviews in biochemistry.
[8] Michael J. Pikal,et al. Rational Design of Stable Lyophilized Protein Formulations: Some Practical Advice , 1997, Pharmaceutical Research.
[9] R. Langer,et al. Formulation and delivery of proteins and peptides , 1994 .
[10] M. Cromwell,et al. Kinetics and thermodynamics of dimer formation and dissociation for a recombinant humanized monoclonal antibody to vascular endothelial growth factor. , 1999, Biochemistry.
[11] T. Arakawa,et al. Size-exclusion chromatography with on-line light-scattering, absorbance, and refractive index detectors for studying proteins and their interactions. , 1996, Analytical biochemistry.
[12] T. Arakawa,et al. Protein–Solvent Interactions in Pharmaceutical Formulations , 1991, Pharmaceutical Research.
[13] V. Bloomfield,et al. Quasi-elastic light scattering applications in biochemistry and biology. , 1981, Annual review of biophysics and bioengineering.
[14] V. Lee. Peptide and protein drug delivery , 1991 .
[15] G. Winter,et al. Formulation of proteins in vacuum-dried glasses. II. Process and storage stability in sugar-free amino acid systems. , 1999, Pharmaceutical development and technology.
[16] P. York,et al. Supercritical fluid processing of proteins: lysozyme precipitation from aqueous solution , 2003, The Journal of pharmacy and pharmacology.
[17] B. Shenoy,et al. Stability of crystalline proteins. , 2001, Biotechnology and bioengineering.
[18] P. Leavis,et al. The solubility of fibrinogen in dilute salt solutions. , 1974, Archives of biochemistry and biophysics.
[19] Chung C. Hsu,et al. Effect of Moisture on the Stability of a Lyophilized Humanized Monoclonal Antibody Formulation , 2001, Pharmaceutical Research.
[20] A. Minton,et al. Confinement as a determinant of macromolecular structure and reactivity. , 1992, Biophysical journal.
[21] D. Kalonia,et al. Steady-state tryptophan fluorescence spectroscopy study to probe tertiary structure of proteins in solid powders. , 2003, Journal of pharmaceutical sciences.
[22] Keith Masters,et al. Spray drying handbook , 1979 .
[23] T. Arakawa,et al. Dehydration-induced conformational transitions in proteins and their inhibition by stabilizers. , 1993, Biophysical journal.
[24] A. Zydney,et al. Membrane separations in biotechnology. , 2001, Current opinion in biotechnology.
[25] P. Royall,et al. Characterisation of the glass transition of HPMC using modulated temperature differential scanning calorimetry. , 1999, International journal of pharmaceutics.
[26] J. Shiloach,et al. Tangential flow filtration. , 1988, Advances in biotechnological processes.
[27] G. Belfort,et al. Comparison of Ultra‐ and Microfiltration in the Presence and Absence of Secondary Flow with Polysaccharides, Proteins, and Yeast Suspensions , 1998, Biotechnology progress.
[28] G. Brazeau,et al. Injectable Drug Development : Techniques to Reduce Pain and Irritation , 1999 .
[29] W. Jenkins. Three solutions of the protein solubility problem. , 1998, Protein science : a publication of the Protein Society.
[30] M. Manning,et al. Chemical and physical pathways of protein degradation , 1992 .
[31] Marc S. Lewis,et al. Modern analytical ultracentrifugation in protein science: A tutorial review , 2002, Protein science : a publication of the Protein Society.
[32] Chung C. Hsu,et al. Fourier‐transform Infrared Spectroscopic Investigation of the Secondary Structure of Aqueous and Dried Recombinant Human Deoxyribonuclease I , 1998 .
[33] John F. Carpenter,et al. Physical Stability of Proteins in Aqueous Solution: Mechanism and Driving Forces in Nonnative Protein Aggregation , 2003, Pharmaceutical Research.
[34] S. Tanabe,et al. Producing a Low Ovomucoid Egg White Preparation by Precipitation with Aqueous Ethanol , 2000, Bioscience, biotechnology, and biochemistry.
[35] Arthur J. Rowe,et al. Analytical ultracentrifugation in biochemistry and polymer science , 1992 .
[36] P. Schuck. Sedimentation analysis of noninteracting and self-associating solutes using numerical solutions to the Lamm equation. , 1998, Biophysical journal.
[37] J. D. de Pablo,et al. Stabilization of Lactate Dehydrogenase Following Freeze-Thawing and Vacuum-Drying in the Presence of Trehalose and Borate , 1998, Pharmaceutical Research.
[38] A. Minton,et al. Evidence for protein self-association induced by excluded volume. Myoglobin in the presence of globular proteins. , 1981, Biochimica et biophysica acta.
[39] Peter Schuck,et al. Size-distribution analysis of proteins by analytical ultracentrifugation: strategies and application to model systems. , 2002, Biophysical journal.
[40] S. D. Webb,et al. Freezing bulk-scale biopharmaceuticals using common techniques: and the magnitude of freeze-concentration , 2002 .
[41] M. Straume,et al. Comments on the Analysis of Sedimentation Equilibrium Experiments , 1994 .
[42] P Dunnill,et al. Action of shear on enzymes: Studies with alcohol dehydrogenase , 1979, Biotechnology and bioengineering.
[43] R. Pecora. Quasi-elastic light scattering from macromolecules. , 1972, Annual review of biophysics and bioengineering.
[44] T. Arakawa,et al. Theory of protein solubility. , 1985, Methods in enzymology.
[45] F. Rothstein. Differential precipitation of proteins. Science and technology. , 1994, Bioprocess technology.
[46] K. Morris,et al. Accelerated fluid bed drying using NIR monitoring and phenomenological modeling: method assessment and formulation suitability. , 2002, Journal of pharmaceutical sciences.
[47] A. Saul,et al. A rapid method of concentrating proteins in small volumes with high recovery using Sephadex G-25. , 1984, Analytical biochemistry.
[48] S. Shire,et al. Characterization of complex formation by humanized anti-IgE monoclonal antibody and monoclonal human IgE. , 1995, Biochemistry.
[49] A. Minton,et al. Macromolecular crowding: biochemical, biophysical, and physiological consequences. , 1993, Annual review of biophysics and biomolecular structure.
[50] Theodore W Randolph,et al. Rational design of stable lyophilized protein formulations: theory and practice. , 2002, Pharmaceutical biotechnology.
[51] D. Brems,et al. Inverse Relationship of Protein Concentration and Aggregation , 2002, Pharmaceutical Research.
[52] T. Laue,et al. Modern Analytical Ultracentrifugation , 1994, Emerging Biochemical and Biophysical Techniques.
[53] J L Cleland,et al. A specific molar ratio of stabilizer to protein is required for storage stability of a lyophilized monoclonal antibody. , 2001, Journal of pharmaceutical sciences.
[54] P. -. Monte,et al. Biotechnology-Based Pharmaceuticals , 2002 .
[55] W. Saenger,et al. Light Scattering Studies on Supersaturated Protein Solutions , 1999, Science progress.
[56] J L Cleland,et al. The development of stable protein formulations: a close look at protein aggregation, deamidation, and oxidation. , 1993, Critical reviews in therapeutic drug carrier systems.
[57] C. Horváth,et al. Salt effect on hydrophobic interactions in precipitation and chromatography of proteins: an interpretation of the lyotropic series. , 1977, Archives of biochemistry and biophysics.
[58] Catherine H. Schein,et al. Solubility as a Function of Protein Structure and Solvent Components , 1990, Bio/Technology.
[59] P. Waser,et al. Shear-induced protein-protein interaction at the air-water interface. , 1974, Biochimica et biophysica acta.
[60] C. Gatlin,et al. Formulation and Administration Techniques to Minimize Injection Pain and Tissue Damage Associated with Parenteral Products , 1999 .
[61] S. Shire. Analytical Ultracentrifugation and its use in Biotechnology , 1994 .
[62] T. Arakawa,et al. Stabilization of protein structure by sugars. , 1982, Biochemistry.
[63] C. Genovesi. Several uses for tangential-flow filtration in the pharmaceutical industry. , 1983, Journal of parenteral science and technology : a publication of the Parenteral Drug Association.
[64] A. Mire-Sluis,et al. Immune responses to therapeutic proteins in humans--clinical significance, assessment and prediction. , 2002, Current pharmaceutical biotechnology.
[65] Jochem Alsenz,et al. Protein Aggregates Seem to Play a Key Role Among the Parameters Influencing the Antigenicity of Interferon Alpha (IFN-α) in Normal and Transgenic Mice , 1997, Pharmaceutical Research.
[66] R. Borchardt,et al. Stability of Protein Pharmaceuticals , 1989, Pharmaceutical Research.