4.5 Article

Evaluating a Modified High Purity Polysorbate 20 Designed to Reduce the Risk of Free Fatty Acid Particle Formation

Related references

Note: Only part of the references are listed.
Article Chemistry, Medicinal

Glass Leachables as a Nucleation Factor for Free Fatty Acid Particle Formation in Biopharmaceutical Formulations

Andrea Allmendinger et al.

Summary: Glass leachables can act as nucleation factors for FFA particle formation. The feasibility of FFA particle nucleation was demonstrated in the presence of inorganic salts simulating relevant glass leachables like NaAlO2 and CaCl2. The enzymatic degradation of parenteral surfactants leading to accumulation of FFAs and potential particle formation is a current industry challenge.

JOURNAL OF PHARMACEUTICAL SCIENCES (2021)

Article Chemistry, Medicinal

In-Use Interfacial Stability of Monoclonal Antibody Formulations Diluted in Saline i.v. Bags

Aadithya Kannan et al.

Summary: The use of monoclonal antibodies (mAbs) for disease treatment is increasing rapidly, with a higher aggregation propensity observed in saline compared to low ionic strength formulation buffer. The presence of salt in buffer with surfactants leads to greater mAb adsorption at the interface and the formation of more particulate aggregates. Stress studies for mAb formulations intended for intravenous administration should be performed in conditions representative of their intended route of administration.

JOURNAL OF PHARMACEUTICAL SCIENCES (2021)

Article Pharmacology & Pharmacy

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

Patrick Garidel et al.

Summary: The study focused on determining the self-association properties of compendial grade polysorbate 20 HP (PS 20 HP) and polysorbate 80 HP (PS 80 HP) regarding micelle size, critical micelle concentration range (cmr), and surface tension. Results showed that PS 80 HP formed larger micelles compared to PS 20 HP, with critical micelle concentration range values (cmr) at 25 degrees Celsius being considerably lower for PS 80 HP. The temperature dependency of the micelle size was more pronounced for PS 80 HP.

JOURNAL OF PHARMACEUTICAL INNOVATION (2021)

Article Chemistry, Medicinal

Extended Characterization and Impact of Visible Fatty Acid Particles - A Case Study With a mAb Product

Miguel Saggu et al.

Summary: This study presents a case analysis of visible particles in biopharmaceutical formulations, specifically focusing on particles resulting from the degradation of the surfactant polysorbate 20. Through techniques such as mass spectrometry, Raman spectroscopy, and flow imaging microscopy, the identity and composition of the particles were determined to support risk assessments. The impact of saline and human plasma exposure on the fate of these particles upon dilution and/or administration was also evaluated to better understand their behavior in clinical settings.

JOURNAL OF PHARMACEUTICAL SCIENCES (2021)

Article Medicine, Research & Experimental

Adsorption and Aggregation of Monoclonal Antibodies at Silicone Oil-Water Interfaces

Aadithya Kannan et al.

Summary: This study shows that different antibodies have different surface activities at oil-water interfaces, directly affecting their aggregation at the interface. The addition of surfactants can competitively lower the adsorption and aggregation of antibodies at the interface, thus stabilizing the antibody formulations.

MOLECULAR PHARMACEUTICS (2021)

Article Chemistry, Multidisciplinary

A Comprehensive Assessment of All-Oleate Polysorbate 80: Free Fatty Acid Particle Formation, Interfacial Protection and Oxidative Degradation

Nidhi Doshi et al.

Summary: AO PS80 shows promise in reducing FFA particle formation compared to other types and grades of PS, but limitations in interfacial protection and oxidation susceptibility need to be considered when assessing its risk/benefit ratio.

PHARMACEUTICAL RESEARCH (2021)

Article Chemistry, Medicinal

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)

Article Medicine, Research & Experimental

Characterization of Polysorbate Ester Fractions and Implications in Protein Drug Product Stability

Anthony Tomlinson et al.

MOLECULAR PHARMACEUTICS (2020)

Article Chemistry, Medicinal

Stabilizing Polysorbate 20 and 80 Against Oxidative Degradation

Ariane Schmidt et al.

JOURNAL OF PHARMACEUTICAL SCIENCES (2020)

Article Chemistry, Multidisciplinary

Impact of Silicone Oil on Free Fatty Acid Particle Formation due to Polysorbate 20 Degradation

Raphael Fish et al.

PHARMACEUTICAL RESEARCH (2020)

Article Biochemical Research Methods

Monitoring polysorbate hydrolysis in biopharmaceuticals using a QC-ready free fatty acid quantification method

Maximilian N. Honemann et al.

JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES (2019)

Article Chemistry, Physical

Linking aggregation and interfacial properties in monoclonal antibody-surfactant formulations

Aadithya Kannan et al.

JOURNAL OF COLLOID AND INTERFACE SCIENCE (2019)

Article Chemistry, Medicinal

Edetate Disodium as a Polysorbate Degradation and Monoclonal Antibody Oxidation Stabilizer

Melissa Yarbrough et al.

JOURNAL OF PHARMACEUTICAL SCIENCES (2019)

Article Chemistry, Analytical

Novel markers to track oxidative polysorbate degradation in pharmaceutical formulations

Sanket Dahotre et al.

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS (2018)

Article Chemistry, Multidisciplinary

Monoclonal Antibody Interfaces: Dilatation Mechanics and Bubble Coalescence

Aadithya Kannan et al.

LANGMUIR (2018)

Review Pharmacology & Pharmacy

Understanding netrins and semaphorins in mature endothelial cell biology

Huayu Zhang et al.

PHARMACOLOGICAL RESEARCH (2018)

Review Pharmacology & Pharmacy

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

Mridula Dwivedi et al.

INTERNATIONAL JOURNAL OF PHARMACEUTICS (2018)

Article Pharmacology & Pharmacy

Chain length affects pancreatic lipase activity and the extent and pH-time profile of triglyceride lipolysis

Paloma Benito-Gallo et al.

EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS (2015)

Article Chemistry, Medicinal

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

Christine C. Siska et al.

JOURNAL OF PHARMACEUTICAL SCIENCES (2015)

Article Medicine, Research & Experimental

Predicting the Agitation-Induced Aggregation of Monoclonal Antibodies Using Surface Tensiometry

Ian C. Shieh et al.

MOLECULAR PHARMACEUTICS (2015)

Article Pharmacology & Pharmacy

Effect of Polysorbate 80 Concentration on Thermal and Photostability of a Monoclonal Antibody

Meera Agarkhed et al.

AAPS PHARMSCITECH (2013)

Review Immunology

Developments and Challenges for mAb-Based Therapeutics

Sumit Goswami et al.

ANTIBODIES (2013)

Article Biochemistry & Molecular Biology

On the role of salt type and concentration on the stability behavior of a monoclonal antibody solution

Paolo Arosio et al.

BIOPHYSICAL CHEMISTRY (2012)

Article Chemistry, Medicinal

Classification of protein aggregates

Linda O. Narhi et al.

JOURNAL OF PHARMACEUTICAL SCIENCES (2012)

Article Chemistry, Multidisciplinary

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)

Article Chemistry, Medicinal

Adsorption Behavior of a Surfactant and a Monoclonal Antibody to Sterilizing-Grade Filters

Hanns-Christian Mahler et al.

JOURNAL OF PHARMACEUTICAL SCIENCES (2010)

Review Chemistry, Medicinal

Protein Aggregation: Pathways, Induction Factors and Analysis

Hanns-Christian Mahler et al.

JOURNAL OF PHARMACEUTICAL SCIENCES (2009)

Editorial Material Chemistry, Medicinal

Overlooking Subvisible Particles in Therapeutic Protein Products: Gaps That May Compromise Product Quality

John F. Carpenter et al.

JOURNAL OF PHARMACEUTICAL SCIENCES (2009)

Article Chemistry, Medicinal

Behaviour of polysorbate 20 during dialysis, concentration and filtration using membrane separation techniques

Hanns-Christian Mahler et al.

JOURNAL OF PHARMACEUTICAL SCIENCES (2008)

Review Chemistry, Medicinal

Polysorbates 20 and 80 used in the formulation of protein biotherapeutics: Structure and degradation pathways

Bruce A. Kerwin

JOURNAL OF PHARMACEUTICAL SCIENCES (2008)

Article Chemistry, Medicinal

Effects of Tween 20® and Tween 80® on the stability of albutropin during agitation

DK Chou et al.

JOURNAL OF PHARMACEUTICAL SCIENCES (2005)

Article Biochemistry & Molecular Biology

A non-radioactive method for measuring Cu uptake in HepG2 cells

C Fosset et al.

JOURNAL OF INORGANIC BIOCHEMISTRY (2005)

Article Chemistry, Medicinal

Peroxide formation in polysorbate 80 and protein stability

E Ha et al.

JOURNAL OF PHARMACEUTICAL SCIENCES (2002)