Polysorbate degradation in biotherapeutic formulations: Identification and discussion of current root causes
Sign Up to like & getrecommendations! Published in 2018 at "International Journal of Pharmaceutics"
DOI: 10.1016/j.ijpharm.2018.10.008
Abstract: ABSTRACT Biotherapeutic protein formulations are often high concentration liquid protein solutions, which are required to be stable under pharmaceutically relevant storage conditions and presence of external stress. Non‐ionic detergents like polysorbate have been the most… read more here.
Keywords: polysorbate degradation; degradation; particle formation; root causes ... See more keywords
Putative Phospholipase B-like 2 is not responsible for polysorbate degradation in monoclonal antibody drug products.
Sign Up to like & getrecommendations! Published in 2020 at "Journal of pharmaceutical sciences"
DOI: 10.1016/j.xphs.2020.05.028
Abstract: Polysorbates (PS) are surfactants commonly added in a therapeutic protein drug product as excipients to protect proteins from denaturation and aggregation during storage, transportation, and delivery. Significant degradation of PS in drug products could lead… read more here.
Keywords: polysorbate degradation; degradation; drug products; drug ... See more keywords