Monoclonal antibodies (mAbs) are subject to instability issues linked to their protein nature.
In this work, we review the different mechanisms that can be linked to monoclonal antibodies …

Given their safety and efficiency in protecting protein integrity, polysorbates (PSs) have been
the most widely used excipients for the stabilization of protein therapeutics for years. In …

The multi-attribute method (MAM), a liquid chromatography-mass spectrometry (LC-MS)-
based peptide mapping method, has gained increased interest and applications in the …

Abstract Polysorbate (PS) 20 and 80 are the main surfactants used to stabilize
biopharmaceutical products. Industry practices on various aspects of PS based on a …

Purpose Polysorbates (PS) are excipients used in the biotech industry to stabilize
monoclonal antibody (mAb) protein products. However, PS in drug product formulations can …

Purpose Enzymatic polysorbate (PS) degradation and resulting free fatty acid (FFA) particles
are detrimental to biopharmaceutical drug product (DP) stability. Different types and grades …

Surfactants are essential components in protein formulations protecting them against
interfacial stress. One of the current industry-wide challenges is enzymatic degradation of …

Residual host cell proteins (HCPs) in the drug product can affect product quality, stability,
and/or safety. In particular, highly active hydrolytic enzymes at sub-ppm levels can …

Hydrolysis of polysorbate in biopharmaceutical products has been ascribed to the enzymatic
activity from trace levels of residual host cell proteins. In recent years, significant efforts to …

Degradation of polysorbate (PS) by hydrolytically active host cell proteins (HCPs) in drug
products may impair the protein-stabilizing properties of PS and lead to the formation of …