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

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

Hydrolytic polysorbate 20 degradation – Sensitive detection of free fatty acids in biopharmaceuticals via UPLC-QDa analytics with isolator column - ScienceDirect

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

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

Polysorbates versus Hydroxypropyl Beta-Cyclodextrin: Comparative Study on Excipient Stability and Stabilization Benefits on Monoclonal Antibodies

Degradation of Polysorbate 20 by Sialate O-Acetylesterase in Monoclonal Antibody Formulations - Journal of Pharmaceutical Sciences

Improving Prediction of Free Fatty Acid Particle Formation in Biopharmaceutical Drug Products: Incorporating Ester Distribution during Polysorbate 20 Degradation

Controlled polysorbate 20 hydrolysis – A new approach to assess the impact of polysorbate 20 degradation on biopharmaceutical product quality in shortened time - ScienceDirect

Enzymatic degradation pattern of polysorbate 20 impacts interfacial properties of monoclonal antibody formulations - ScienceDirect

Improving Prediction of Free Fatty Acid Particle Formation in Biopharmaceutical Drug Products: Incorporating Ester Distribution during Polysorbate 20 Degradation

Trends on Analytical Characterization of Polysorbates and Their Degradation Products in Biopharmaceutical Formulations - Journal of Pharmaceutical Sciences