Related references
Note: Only part of the references are listed.Characterization of Recombinantly-Expressed Hydrolytic Enzymes from Chinese Hamster Ovary Cells: Identification of Host Cell Proteins that Degrade Polysorbate
Daniel Kovner et al.
JOURNAL OF PHARMACEUTICAL SCIENCES (2023)
Industry Perspective on the use and Characterization of Polysorbates for Biopharmaceutical Products Part 1: Survey Report on Current State and Common Practices for Handling and Control of Polysorbates
Klaus Wuchner et al.
JOURNAL OF PHARMACEUTICAL SCIENCES (2022)
Metal-Induced Fatty Acid Particle Formation Resulting from Hydrolytic Polysorbate Degradation
Kathrin Gregoritza et al.
JOURNAL OF PHARMACEUTICAL SCIENCES (2022)
Near UV and Visible Light Photo-Degradation Mechanisms in Citrate Buffer: One-Electron Reduction of Peptide and Protein Disulfides promotes Oxidation and Cis/Trans Isomerization of Unsaturated Fatty Acids of Polysorbate 80
Indira Prajapati et al.
JOURNAL OF PHARMACEUTICAL SCIENCES (2022)
Characterization of Polysorbate 80 by Liquid Chromatography-Mass Spectrometry to Understand Its Susceptibility to Degradation and Its Oxidative Degradation Pathway
Haiyan Liu et al.
JOURNAL OF PHARMACEUTICAL SCIENCES (2022)
Mechanistic understanding of metal-catalyzed oxidation of polysorbate 80 and monoclonal antibody in biotherapeutic formulations
Fethi Bensaid et al.
INTERNATIONAL JOURNAL OF PHARMACEUTICS (2022)
Oxidative Stability in Lipid Formulations: a Review of the Mechanisms, Drivers, and Inhibitors of Oxidation
Jasmine Musakhanian et al.
AAPS PHARMSCITECH (2022)
Glass Leachables as a Nucleation Factor for Free Fatty Acid Particle Formation in Biopharmaceutical Formulations
Andrea Allmendinger et al.
JOURNAL OF PHARMACEUTICAL SCIENCES (2021)
Assessing the polysorbate degradation fingerprints and kinetics of lipases-how the activity of polysorbate degrading hydrolases is influenced by the assay and assay conditions
Nils Gluecklich et al.
EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES (2021)
Identification of an Oxidizing Leachable from a Clinical Syringe Rubber Stopper
Ariane Schroeter et al.
JOURNAL OF PHARMACEUTICAL SCIENCES (2021)
Polysorbate Degradation and Particle Formation in a High Concentration mAb: Formulation Strategies to Minimize Effect of Enzymatic Polysorbate Degradation
Ian Roy et al.
JOURNAL OF PHARMACEUTICAL SCIENCES (2021)
Degradation of Polysorbate 20 by Sialate O-Acetylesterase in Monoclonal Antibody Formulations
Sisi Zhang et al.
JOURNAL OF PHARMACEUTICAL SCIENCES (2021)
Identification and Characterization of Polysorbate-Degrading Enzymes in a Monoclonal Antibody Formulation
Tobias Graf et al.
JOURNAL OF PHARMACEUTICAL SCIENCES (2021)
Comparison of Polysorbate 80 Hydrolysis and Oxidation on the Aggregation of a Monoclonal Antibody
Nicholas R. Larson et al.
JOURNAL OF PHARMACEUTICAL SCIENCES (2020)
Acidic and alkaline hydrolysis of polysorbates under aqueous conditions: Towards understanding polysorbate degradation in biopharmaceutical formulations
Mridula Dwivedi et al.
EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES (2020)
Micellar Morphology of Polysorbate 20 and 80 and Their Ester Fractions in Solution via Small-Angle Neutron Scattering
Jannatun Nayem et al.
JOURNAL OF PHARMACEUTICAL SCIENCES (2020)
Rational design to biologics development: The polysorbates point of view
Ema Valentina Brovc et al.
INTERNATIONAL JOURNAL OF PHARMACEUTICS (2020)
Characterization of Polysorbate Ester Fractions and Implications in Protein Drug Product Stability
Anthony Tomlinson et al.
MOLECULAR PHARMACEUTICS (2020)
Development and validation of a selective marker-based quantification of polysorbate 20 in biopharmaceutical formulations using UPLC QDa detection
Dirk-Heinrich Evers et al.
JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES (2020)
Micelle Driven Oxidation Mechansim and Novel Oxidation Markers for Different Grades of Polysorbate 20 and 80
Wendelin Kranz et al.
JOURNAL OF PHARMACEUTICAL SCIENCES (2020)
Degradation of polysorbates 20 and 80 catalysed by histidine chloride buffer
Ema Valentina Brovc et al.
EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS (2020)
Edetate Disodium as a Polysorbate Degradation and Monoclonal Antibody Oxidation Stabilizer
Melissa Yarbrough et al.
JOURNAL OF PHARMACEUTICAL SCIENCES (2019)
Factors Influencing Polysorbate's Sensitivity Against Enzymatic Hydrolysis and Oxidative Degradation
Wendelin Kranz et al.
JOURNAL OF PHARMACEUTICAL SCIENCES (2019)
Evaluation of Glass Delamination Risk in Pharmaceutical 10 mL/10R Vials
Dominique Ditter et al.
JOURNAL OF PHARMACEUTICAL SCIENCES (2018)
Impact of Vial Washing and Depyrogenation on Surface Properties and Delamination Risk of Glass Vials
Dominique Ditter et al.
PHARMACEUTICAL RESEARCH (2018)
Dual Effect of Histidine on Polysorbate 20 Stability: Mechanistic Studies
Lin Zhang et al.
PHARMACEUTICAL RESEARCH (2018)
Polysorbate degradation in biotherapeutic formulations: Identification and discussion of current root causes
Mridula Dwivedi et al.
INTERNATIONAL JOURNAL OF PHARMACEUTICS (2018)
Knockout of a difficult-to-remove CHO host cell protein, lipoprotein lipase, for improved polysorbate stability in monoclonal antibody formulations
Josephine Chiu et al.
BIOTECHNOLOGY AND BIOENGINEERING (2017)
Impact of mono- and poly-ester fractions on polysorbate quantitation using mixed-mode HPLC-CAD/ELSD and the fluorescence micelle assay
Steffen Lippold et al.
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS (2017)
Residual Host Cell Protein Promotes Polysorbate 20 Degradation in a Sulfatase Drug Product Leading to Free Fatty Acid Particles
Nitin Dixit et al.
JOURNAL OF PHARMACEUTICAL SCIENCES (2016)
Polysorbates 20 and 80 Degradation by Group XV Lysosomal Phospholipase A2 Isomer X1 in Monoclonal Antibody Formulations
Troii Hall et al.
JOURNAL OF PHARMACEUTICAL SCIENCES (2016)
Oxidative Degradation of Polysorbate Surfactants Studied by Liquid Chromatography-Mass Spectrometry
Oleg V. Borisov et al.
JOURNAL OF PHARMACEUTICAL SCIENCES (2015)
Free Radicals: Properties, Sources, Targets, and Their Implication in Various Diseases
Alugoju Phaniendra et al.
INDIAN JOURNAL OF CLINICAL BIOCHEMISTRY (2015)
Detection and characterisation of radicals in biological materials using EPR methodology
Clare L. Hawkins et al.
BIOCHIMICA ET BIOPHYSICA ACTA-GENERAL SUBJECTS (2014)
Structure Formation of Ultrathin PEO Films at Solid Interfaces-Complex Pattern Formation by Dewetting and Crystallization
Hans-Georg Braun et al.
INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES (2013)
Characterization of polysorbate 80 with liquid chromatography mass spectrometry and nuclear magnetic resonance spectroscopy: Specific determination of oxidation products of thermally oxidized polysorbate 80
Erlend Hvattum et al.
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS (2012)
Biologics Formulation Factors Affecting Metal Leachables from Stainless Steel
Shuxia Zhou et al.
AAPS PHARMSCITECH (2011)
Mixed-mode and reversed-phase liquid chromatography-tandem mass spectrometry methodologies to study composition and base hydrolysis of polysorbate 20 and 80
Daniel Hewitt et al.
JOURNAL OF CHROMATOGRAPHY A (2011)
Effects of Surfaces and Leachables on the Stability of Biopharmaceuticals
Jared S. Bee et al.
JOURNAL OF PHARMACEUTICAL SCIENCES (2011)
The Degradation of Polysorbates 20 and 80 and its Potential Impact on the Stability of Biotherapeutics
Ravuri S. K. Kishore et al.
PHARMACEUTICAL RESEARCH (2011)
New Mechanistic Aspects of the Fenton Reaction
Sandra Rachmilovich-Calis et al.
CHEMISTRY-A EUROPEAN JOURNAL (2009)
Effect of pH on Fenton and Fenton-like oxidation
Yong Sik Jung et al.
ENVIRONMENTAL TECHNOLOGY (2009)
A Quantitative Kinetic Study of Polysorbate Autoxidation: The Role of Unsaturated Fatty Acid Ester Substituents
Jia Yao et al.
PHARMACEUTICAL RESEARCH (2009)
Degradation of melatonin by UV, UV/H2O2, Fe2+/H2O2 and UV/Fe2+/H2O2 processes
Xiang-Rong Xu et al.
SEPARATION AND PURIFICATION TECHNOLOGY (2009)
Polysorbates 20 and 80 used in the formulation of protein biotherapeutics: Structure and degradation pathways
Bruce A. Kerwin
JOURNAL OF PHARMACEUTICAL SCIENCES (2008)
Formulation and delivery issues for monoclonal antibody therapeutics
Ann L. Daugherty et al.
ADVANCED DRUG DELIVERY REVIEWS (2006)
Protein drug stability: A formulation challenge
S Frokjaer et al.
NATURE REVIEWS DRUG DISCOVERY (2005)
Kinetics of spin trapping superoxide, hydroxyl, and aliphatic radicals by cyclic nitrones
S Goldstein et al.
JOURNAL OF PHYSICAL CHEMISTRY A (2004)
Peroxide formation in polysorbate 80 and protein stability
E Ha et al.
JOURNAL OF PHARMACEUTICAL SCIENCES (2002)
The Haber-Weiss cycle - 70 years later
WH Koppenol
REDOX REPORT (2001)