ArticleJournal of pharmaceutical sciences2013
The effects of excipients on protein aggregation during agitation: an interfacial shear rheology study.
Article in Journal of pharmaceutical sciences, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.
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Who cites it
19 citing papers in PubMed, 87 citations in OpenAlex.
- Inactivation of PETase at Interfaces Inhibits PET Plastic Depolymerization.ACS sustainable chemistry & engineering · 2026Article
- Optimization of a recombinant BlaR-CTD protein formulation using the response surface methodology.Journal of biological engineering · 2024Article
- Small-angle x-ray scattering investigation of the integration of free fatty acids in polysorbate 20 micelles.Biophysical journal · 2023Article
- Comparison of Protein Particle Formation in IgG1 mAbs Formulated with PS20 Vs. PS80 When Subjected to Interfacial Dilatational Stress.AAPS PharmSciTech · 2023Article
- Alternative Excipients for Protein Stabilization in Protein Therapeutics: Overcoming the Limitations of Polysorbates.Pharmaceutics · 2022Review
- Comparative Evaluation of the Performance of Sterile Filters for Bioburden Protection and Final Fill in Biopharmaceutical Processes.Membranes · 2022Article
- Assessment of Therapeutic Antibody Developability by Combinations of In Vitro and In Silico Methods.Methods in molecular biology (Clifton, N.J.) · 2022Article
- Aggregation of protein therapeutics enhances their immunogenicity: causes and mitigation strategies.RSC chemical biology · 2021Review
- DEHP Nanodroplets Leached From Polyvinyl Chloride IV Bags Promote Aggregation of IVIG and Activate Complement in Human Serum.Journal of pharmaceutical sciences · 2020Article
- Parameters Influencing Cavitation Within Vials Subjected to Drop Shock.Scientific reports · 2019Article
- Studying Excipient Modulated Physical Stability and Viscosity of Monoclonal Antibody Formulations Using Small-Angle Scattering.Molecular pharmaceutics · 2019Article
- Protein-protein interactions controlling interfacial aggregation of rhIL-1ra are not described by simple colloid models.Protein science : a publication of the Protein Society · 2018Article
- 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 Spectroscopy.Journal of pharmaceutical sciences · 2017Article
- Thermoresponsive Gels.Gels (Basel, Switzerland) · 2017Review
- Particle Formation and Aggregation of a Therapeutic Protein in Nanobubble Suspensions.Journal of pharmaceutical sciences · 2016Article
- Surfactant Effects on Particle Generation in Antibody Formulations in Pre-filled Syringes.Journal of pharmaceutical sciences · 2015Article
- Advanced protein formulations.Protein science : a publication of the Protein Society · 2015Review
- Effects of syringe material and silicone oil lubrication on the stability of pharmaceutical proteins.Journal of pharmaceutical sciences · 2015Article
- Remediating agitation-induced antibody aggregation by eradicating exposed hydrophobic motifs.mAbs · 2014Article
Corrections and comments
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Authors and funding
5 authors at 3 institutions in 1 country.
Funding
Abstract
We investigated the effects of excipients in solutions of keratinocyte growth factor 2 (KGF-2) on protein aggregation during agitation as well as on interfacial shear rheology at the air-water interface. Samples were incubated with or without agitation, and in the presence or absence of the excipients heparin, sucrose, or polysorbate 80 (PS80). The effect of excipients on the extent of protein aggregation was determined by UV-visible spectroscopy and micro-flow imaging. Interfacial shear rheology was used to detect the gelation time and strength of protein gels at the air-water interface. During incubation, protein particles of size ≥1 μm and insoluble aggregates formed faster for KGF-2 solutions subjected to agitation. Addition of either heparin or sucrose promoted protein aggregation during agitation. In contrast, PS80 substantially inhibited agitation-induced KGF-2 aggregation but facilitated protein particulate formation in quiescent solutions. The combination of PS80 and heparin or sucrose completely prevented protein aggregation during both nonagitated and agitated incubations. Interfacial rheological measurements showed that KGF-2 in buffer alone formed an interfacial gel within a few minutes. In the presence of heparin, KGF-2 interfacial gels formed too quickly for gelation time to be determined. KGF-2 formed gels in about 10 min in the presence of sucrose. The presence of PS80 in the formulation inhibited gelation of KGF-2. Furthermore, the interfacial gels formed by the protein in the absence of PS80 were reversible when PS80 was added to the samples after gelation. Therefore, there is a correspondence between formulations that exhibited interfacial gelation and formulations that exhibited agitation-induced aggregation.
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