What Makes Polysorbate Functional? Impact of Polysorbate 80 Grade and Quality on IgG Stability During Mechanical Stress

scientific article published on 12 October 2019

What Makes Polysorbate Functional? Impact of Polysorbate 80 Grade and Quality on IgG Stability During Mechanical Stress is …
instance of (P31):
scholarly articleQ13442814

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P356DOI10.1016/J.XPHS.2019.10.015
P698PubMed publication ID31614127

P50authorWim JiskootQ67247173
P2093author name stringTim Menzen
Klaus Wuchner
Andrea Hawe
Wendelin Kranz
Adam Dariusz Grabarek
Jannik Rousel
Ula Bozic
P2860cites workTween protects recombinant human growth hormone against agitation-induced damage via hydrophobic interactionsQ77214878
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Meeting report on protein particles and immunogenicity of therapeutic proteins: filling in the gaps in risk evaluation and mitigationQ84721767
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Degradation of Polysorbates 20 and 80: Studies on Thermal Autoxidation and HydrolysisQ84965958
Free fatty acid particles in protein formulations, part 2: contribution of polysorbate raw materialQ85266301
Competitive adsorption of monoclonal antibodies and nonionic surfactants at solid hydrophobic surfacesQ86103734
Gelation of a monoclonal antibody at the silicone oil-water interface and subsequent rupture of the interfacial gel results in aggregation and particle formationQ86634452
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Protein denaturation by combined effect of shear and air-liquid interfaceQ38554752
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The effects of excipients on protein aggregation during agitation: an interfacial shear rheology studyQ41907182
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Ester hydrolysis of polysorbate 80 in mAb drug product: evidence in support of the hypothesized risk after the observation of visible particulate in mAb formulationsQ44281946
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Physical and biophysical effects of polysorbate 20 and 80 on darbepoetin alfa.Q46039740
Effect of Polysorbate 20 and Polysorbate 80 on the Higher-Order Structure of a Monoclonal Antibody and Its Fab and Fc Fragments Probed Using 2D Nuclear Magnetic Resonance SpectroscopyQ47902036
Friability Testing as a New Stress-Stability Assay for BiopharmaceuticalsQ48028978
A platform for preparing homogeneous proteinaceous sub-visible particles with distinct morphologies.Q51731806
Polysorbates 20 and 80 Degradation by Group XV Lysosomal Phospholipase A2 Isomer X1 in Monoclonal Antibody Formulations.Q51738350
Insights into protein-polysorbate interactions analysed by means of isothermal titration and differential scanning calorimetry.Q51843226
Hydrolysis of Polysorbate 20 and 80 by a Range of Carboxylester Hydrolases.Q53136814
Impact of Cavitation, High Shear Stress and Air/Liquid Interfaces on Protein Aggregation.Q53426266
Postproduction Handling and Administration of Protein Pharmaceuticals and Potential Instability IssuesQ56977090
Polysorbate degradation in biotherapeutic formulations: Identification and discussion of current root causesQ57296963
Protein aggregation - Mechanisms, detection, and controlQ57785794
Factors influencing antibody stability at solid-liquid interfaces in a high shear environmentQ58338079
Interfacial Stress in the Development of Biologics: Fundamental Understanding, Current Practice, and Future PerspectiveQ64116563
P433issue1
P304page(s)871-880
P577publication date2019-10-12
P1433published inJournal of Pharmaceutical SciencesQ3186933
P1476titleWhat Makes Polysorbate Functional? Impact of Polysorbate 80 Grade and Quality on IgG Stability During Mechanical Stress
P478volume109

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cites work (P2860)
Q104060473A Rapid, Small-Volume Approach to evaluate Protein Aggregation at Air-Water Interfaces
Q100509518Glass leachables as a nucleation factor for free fatty acid particle formation in biopharmaceutical formulations
Q100311645Impact of polysorbate 80 grade on the interfacial properties and interfacial stress induced subvisible particle formation in monoclonal antibodies