首页|Assessing the polysorbate degradation fingerprints and kinetics of lipases-how the activity of polysorbate degrading hydrolases is influenced by the assay and assay conditions
Assessing the polysorbate degradation fingerprints and kinetics of lipases-how the activity of polysorbate degrading hydrolases is influenced by the assay and assay conditions
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NSTL
Elsevier
Two of the most widely used surfactants to stabilize biologicals against e.g. interfacial stresses are polysorbate 20 (PS20) and polysorbate 80 (PS80). In recent years, numerous cases of hydrolytic polysorbate (PS) degradation in liquid formulations of biopharmaceuticals have been observed. Concomitant with the degradation of PSs, formulated proteins become inherently instable and more susceptible to aggregation. Furthermore, poorly soluble fatty acids (FA) are released from the PSs, which might lead to FA precipitation and the formation of visible and subvisible particles. Therefore, possible particle inducing factors have to be monitored closely.
NSTL
Elsevier
