Considerations for the Use of Polysorbates in Biopharmaceuticals
暂无分享,去创建一个
John Wang | Wei Liu | Sandeep Yadav | Kapil Gupta | Atanas Koulov | Satish K Singh | Hanns-Christian Mahler | Michael T Jones | Dilbir Bindra | Vincent Corvari | R Matthew Fesinmeyer | Alexander M Harmon | Kenneth D Hinds | Kevin Maloney | Ping Y Yeh | D. Bindra | R. Fesinmeyer | K. Gupta | K. Maloney | A. Koulov | S. Yadav | V. Corvari | Atanas V. Koulov | John Wang | K. Hinds | P. Yeh | Wei Liu | Alexander M. Harmon | Hanns-Christian Mahler | Satish K. Singh | Michael T. Jones | K. Gupta | Kevin Maloney | Michael T. Jones | Alexander M. Harmon | Kenneth D. Hinds | Ping Y. Yeh | Satish K. Singh
[1] R. Hatcher. THE UNITED STATES PHARMACOPEIA. , 1908 .
[2] D. Brems,et al. Inverse Relationship of Protein Concentration and Aggregation , 2002, Pharmaceutical Research.
[3] E. Setzkorn,et al. A colorimetric method for the determination of parts/million of nonionic surfactants , 1965 .
[4] Hanns-Christian Mahler,et al. The Degradation of Polysorbates 20 and 80 and its Potential Impact on the Stability of Biotherapeutics , 2011, Pharmaceutical Research.
[5] B. Kerwin,et al. Effects of Tween 80 and sucrose on acute short-term stability and long-term storage at -20 degrees C of a recombinant hemoglobin. , 1998, Journal of pharmaceutical sciences.
[6] Hanns-Christian Mahler,et al. Adsorption behavior of a surfactant and a monoclonal antibody to sterilizing-grade filters. , 2010, Journal of pharmaceutical sciences.
[7] B. Chang,et al. Surface-induced denaturation of proteins during freezing and its inhibition by surfactants. , 1996, Journal of pharmaceutical sciences.
[8] J. Silha,et al. The HLB number determination of polyoxyethylene surfactants , 1989 .
[9] J. Penfold,et al. Spontaneous surface self-assembly in protein-surfactant mixtures: interactions between hydrophobin and ethoxylated polysorbate surfactants. , 2014, The journal of physical chemistry. B.
[10] Theodore W Randolph,et al. Surfactant-protein interactions. , 2002, Pharmaceutical biotechnology.
[11] J. Gaddum,et al. United States Pharmacopeia , 1955, Nature.
[12] Jinshu Qiu,et al. Quantitation of low concentrations of polysorbates in high protein concentration formulations by solid phase extraction and cobalt-thiocyanate derivatization. , 2014, Analytica chimica acta.
[13] J L Cleland,et al. Tween protects recombinant human growth hormone against agitation-induced damage via hydrophobic interactions. , 1998, Journal of pharmaceutical sciences.
[14] A. Pappenberger,et al. Degradation of polysorbates 20 and 80: studies on thermal autoxidation and hydrolysis. , 2011, Journal of pharmaceutical sciences.
[15] B. Kerwin. Polysorbates 20 and 80 used in the formulation of protein biotherapeutics: structure and degradation pathways. , 2008, Journal of pharmaceutical sciences.
[16] L. Nair,et al. Determination of polysorbate 80 in parenteral formulations by high-performance liquid chromatography and evaporative light scattering detection. , 2003, Journal of chromatography. A.
[17] A. Ross,et al. Evaluation of the immuno-stimulatory potential of stopper extractables and leachables by using dendritic cells as readout. , 2009, Journal of pharmaceutical sciences.
[18] Ankit Patel,et al. Identification of Subvisible Particles in Biopharmaceutical Formulations Using Raman Spectroscopy Provides Insight into Polysorbate 20 Degradation Pathway , 2015, Pharmaceutical Research.
[19] T. Arakawa,et al. Interactions of stabilizing additives with proteins during freeze-thawing and freeze-drying. , 1992, Developments in biological standardization.
[20] H. Ishiwata,et al. [Determination method of polysorbates in powdered soup by HPLC]. , 2001, Shokuhin eiseigaku zasshi. Journal of the Food Hygienic Society of Japan.
[21] Hanns-Christian Mahler,et al. Induction and analysis of aggregates in a liquid IgG1-antibody formulation. , 2005, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.
[22] Y. J. Wang,et al. Toward understanding molecular heterogeneity of polysorbates by application of liquid chromatography-mass spectrometry with computer-aided data analysis. , 2011, Analytical chemistry.
[23] E. G. Brown,et al. The absorptiometric determination of polyethyleneglycol mono-oleate , 1955 .
[24] A. Banga,et al. Use of poloxamer polymers to stabilize recombinant human growth hormone against various processing stresses. , 1997, Pharmaceutical development and technology.
[25] John F. Carpenter,et al. Physical Stability of Proteins in Aqueous Solution: Mechanism and Driving Forces in Nonnative Protein Aggregation , 2003, Pharmaceutical Research.
[26] J. Lindgren,et al. Protection mechanism of Tween 80 during freeze-thawing of a model protein, LDH. , 2002, International journal of pharmaceutics.
[27] Ann L. Lee,et al. An automated homogeneous method for quantifying polysorbate using fluorescence polarization. , 2005, Analytical biochemistry.
[28] K. Mittal. Determination of CMC of polysorbate 20 in aqueous solution by surface tension method. , 1972, Journal of pharmaceutical sciences.
[29] S. Charman,et al. Techniques for Assessing the Effects of Pharmaceutical Excipients on the Aggregation of Porcine Growth Hormone , 1993, Pharmaceutical Research.
[30] H. K. Khor,et al. Use of ferric thiocyanate derivatization for quantification of polysorbate 80 in high concentration protein formulations. , 2014, Talanta.
[31] Theodore W Randolph,et al. Protein adsorption and excipient effects on kinetic stability of silicone oil emulsions. , 2010, Journal of pharmaceutical sciences.
[32] M. Manning,et al. Effect of Tween 20 on freeze-thawing- and agitation-induced aggregation of recombinant human factor XIII. , 1998, Journal of pharmaceutical sciences.
[33] T. Randolph,et al. Surfactant-Stabilized Protein Formulations: A Review of Protein-Surfactant Interactions and Novel Analytical Methodologies , 1997 .
[34] Katherine D Taylor,et al. Residual Host Cell Protein Promotes Polysorbate 20 Degradation in a Sulfatase Drug Product Leading to Free Fatty Acid Particles. , 2016, Journal of pharmaceutical sciences.
[35] Sandeep Yadav,et al. Polysorbate 20 Degradation in Biopharmaceutical Formulations: Quantification of Free Fatty Acids, Characterization of Particulates, and Insights into the Degradation Mechanism. , 2015, Molecular pharmaceutics.
[36] J. Brandner. The composition of NF-defined emulsifiers: sorbitan monolaurate, monopalmitate, monostearate, monooleate, polysorbate 20, polysorbate 40, polysorbate 60, and polysorbate 80. , 1998, Drug development and industrial pharmacy.
[37] Arvind Srivastava,et al. Effect of Polysorbate 80 Concentration on Thermal and Photostability of a Monoclonal Antibody , 2012, AAPS PharmSciTech.
[38] B. Kerwin,et al. Effects of Tween 80 and Sucrose on Acute Short-Term Stability and Long-Term Storage at − 20 C of a Recombinant Hemoglobin , 1998 .
[39] L. Bell,et al. Effect of surfactants on the physical stability of recombinant human growth hormone. , 1995, Journal of pharmaceutical sciences.
[40] Sandeep Yadav,et al. Understanding Particle Formation: Solubility of Free Fatty Acids as Polysorbate 20 Degradation Byproducts in Therapeutic Monoclonal Antibody Formulations. , 2015, Molecular pharmaceutics.
[41] Y. J. Wang,et al. Dual effects of Tween 80 on protein stability. , 2008, International journal of pharmaceutics.
[42] W. Vaz,et al. Determination of the critical micelle concentration of surfactants using the fluorescent probe N-phenyl-1-naphthylamine. , 1986, Analytical biochemistry.
[43] Abraham M Lenhoff,et al. Host cell protein impurities in chromatographic polishing steps for monoclonal antibody purification , 2016, Biotechnology and bioengineering.
[44] T. R. Bates,et al. Kinetics of hydrolysis of polyoxyethylene (20) sorbitan fatty acid ester surfactants , 1973, The Journal of pharmacy and pharmacology.
[45] Lihua Huang,et al. Polysorbates 20 and 80 Degradation by Group XV Lysosomal Phospholipase A2 Isomer X1 in Monoclonal Antibody Formulations. , 2016, Journal of pharmaceutical sciences.
[46] Kelvin H. Lee,et al. Knockout of a difficult‐to‐remove CHO host cell protein, lipoprotein lipase, for improved polysorbate stability in monoclonal antibody formulations , 2017, Biotechnology and bioengineering.
[47] Y. J. Wang,et al. Degradation Mechanisms of Polysorbate 20 Differentiated by 18O-labeling and Mass Spectrometry , 2016, Pharmaceutical Research.
[48] T. Patapoff,et al. Single step method for the accurate concentration determination of polysorbate 80 , 1997 .
[49] Yi Li,et al. Characterization and stability study of polysorbate 20 in therapeutic monoclonal antibody formulation by multidimensional ultrahigh-performance liquid chromatography-charged aerosol detection-mass spectrometry. , 2014, Analytical chemistry.
[50] Jared S. Bee,et al. Gelation of a monoclonal antibody at the silicone oil-water interface and subsequent rupture of the interfacial gel results in aggregation and particle formation. , 2015, Journal of pharmaceutical sciences.
[51] John Devincentis,et al. A simple reversed phase high-performance liquid chromatography method for polysorbate 80 quantitation in monoclonal antibody drug products. , 2010, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.
[52] J. Ji,et al. Mixed-mode and reversed-phase liquid chromatography-tandem mass spectrometry methodologies to study composition and base hydrolysis of polysorbate 20 and 80. , 2011, Journal of chromatography. A.
[53] T. Randolph,et al. Stability of Protein Formulations: Investigation of Surfactant Effects by a Novel EPR Spectroscopic Technique , 2004, Pharmaceutical Research.
[54] Jennifer R Litowski,et al. Free fatty acid particles in protein formulations, part 2: contribution of polysorbate raw material. , 2015, Journal of pharmaceutical sciences.
[55] H. Levine,et al. The use of surface tension measurements in the design of antibody-based product formulations. , 1991, Journal of parenteral science and technology : a publication of the Parenteral Drug Association.
[56] Steven R Labrenz,et al. Ester hydrolysis of polysorbate 80 in mAb drug product: evidence in support of the hypothesized risk after the observation of visible particulate in mAb formulations. , 2014, Journal of pharmaceutical sciences.
[57] Y. Kao,et al. Quantitation of polysorbate 20 in protein solutions using mixed-mode chromatography and evaporative light scattering detection. , 2008, Journal of chromatography. A.