An in-depth examination of fatty acid solubility limits in biotherapeutic protein formulations containing polysorbate 20 and polysorbate 80

Acidic and alkaline hydrolysis of polysorbates under aqueous conditions: Towards understanding polysorbate degradation in biopharmaceutical formulations

(2020) Mridula Dwivedi et al.   EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Albumin displacement at the air–water interface by Tween (Polysorbate) surfactants

(2020) Martin Rabe et al.   EUROPEAN BIOPHYSICS JOURNAL WITH BIOPHYSICS LETTERS

Surface Tension and Self-association Properties of Aqueous Polysorbate 20 HP and 80 HP Solutions: Insights into Protein Stabilisation Mechanisms

(2020) Patrick Garidel et al.   Journal of Pharmaceutical Innovation

Experience with host cell protein impurities in biopharmaceuticals

(2018) Martin Vanderlaan et al.   BIOTECHNOLOGY PROGRESS

Considerations for the Use of Polysorbates in Biopharmaceuticals

(2018) Michael T. Jones et al.   PHARMACEUTICAL RESEARCH

Polysorbate degradation in biotherapeutic formulations: Identification and discussion of current root causes

(2018) Mridula Dwivedi et al.   INTERNATIONAL JOURNAL OF PHARMACEUTICS

Trends on Analytical Characterization of Polysorbates and Their Degradation Products in Biopharmaceutical Formulations

(2017) Ariadna Martos et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Sustainable oleic and stearic acid based biodegradable surfactants

(2017) Avinash Bhadani et al.   RSC Advances

Knockout of a difficult-to-remove CHO host cell protein, lipoprotein lipase, for improved polysorbate stability in monoclonal antibody formulations

(2016) Josephine Chiu et al.   BIOTECHNOLOGY AND BIOENGINEERING

Does the commonly used pH-stat method with back titration really quantify the enzymatic digestibility of lipid drug delivery systems? A case study on solid lipid nanoparticles (SLN)

(2016) Martha Heider et al.   EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

Residual Host Cell Protein Promotes Polysorbate 20 Degradation in a Sulfatase Drug Product Leading to Free Fatty Acid Particles

(2016) Nitin Dixit et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Polysorbates 20 and 80 Degradation by Group XV Lysosomal Phospholipase A 2 Isomer X1 in Monoclonal Antibody Formulations

(2016) Troii Hall et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Predicting critical micelle concentration and micelle molecular weight of polysorbate 80 using compendial methods

(2015) Alexandra C. Braun et al.   EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

Oxidative Degradation of Polysorbate Surfactants Studied by Liquid Chromatography–Mass Spectrometry

(2015) Oleg V. Borisov et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Free Fatty Acid Particles in Protein Formulations, Part 2: Contribution of Polysorbate Raw Material

(2015) Christine C. Siska et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Polysorbate 20 Degradation in Biopharmaceutical Formulations: Quantification of Free Fatty Acids, Characterization of Particulates, and Insights into the Degradation Mechanism

(2015) Anthony Tomlinson et al.   MOLECULAR PHARMACEUTICS

Understanding Particle Formation: Solubility of Free Fatty Acids as Polysorbate 20 Degradation Byproducts in Therapeutic Monoclonal Antibody Formulations

(2015) Nidhi Doshi et al.   MOLECULAR PHARMACEUTICS

Identification of Subvisible Particles in Biopharmaceutical Formulations Using Raman Spectroscopy Provides Insight into Polysorbate 20 Degradation Pathway

(2015) Miguel Saggu et al.   PHARMACEUTICAL RESEARCH

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) Steven R. Labrenz   JOURNAL OF PHARMACEUTICAL SCIENCES

Effect of Temperature on the Critical Micelle Concentration and Micellization Thermodynamic of Nonionic Surfactants: Polyoxyethylene Sorbitan Fatty Acid Esters

(2012) Ehsan Mohajeri et al.   E-Journal of Chemistry

Complement activation by polyethoxylated pharmaceutical surfactants: Cremophor-EL, Tween-80 and Tween-20

(2011) Zsóka Weiszhár et al.   EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Solubility limits and phase diagrams for fatty acids in anionic (SLES) and zwitterionic (CAPB) micellar surfactant solutions

(2011) Sylvia S. Tzocheva et al.   JOURNAL OF COLLOID AND INTERFACE SCIENCE

The Degradation of Polysorbates 20 and 80 and its Potential Impact on the Stability of Biotherapeutics

(2011) Ravuri S. K. Kishore et al.   PHARMACEUTICAL RESEARCH

The solubilization of fatty acids in systems based on block copolymers and nonionic surfactants

(2011) A. B. Mirgorodskaya et al.   Russian Journal of Physical Chemistry A

Mixed-mode and reversed-phase liquid chromatography–tandem mass spectrometry methodologies to study composition and base hydrolysis of polysorbate 20 and 80

(2010) Daniel Hewitt et al.   JOURNAL OF CHROMATOGRAPHY A

Polysorbates 20 and 80 Used in the Formulation of Protein Biotherapeutics: Structure and Degradation Pathways

(2007) Bruce A. Kerwin   JOURNAL OF PHARMACEUTICAL SCIENCES