Polysorbate 20 is a surfactant common in biopharmaceuticals; in two antibody products stored 18 to 36 months at 2-8 C it degraded into free fatty acids that precipitated as particles.
preclinical — animal, cell or mechanistic work — not yet about people
every claim resolves to its source
All 2 citations resolve to their original source. · 0 posts naming it, 0 members counted once each.
Summary
Polysorbate 20 is a surfactant common in biopharmaceuticals; in two antibody products stored 18 to 36 months at 2-8 C it degraded into free fatty acids that precipitated as particles. · pmid:26419339
History
Residual host cell protein in a drug product has been shown to promote polysorbate 20 degradation leading to free fatty acid particles. · pmid:27032893
Identity
No public registry record is shown for this page: PubChem gave no record that proves it is this substance.
Where the evidence actually sits
Preclinical only100%
Proportion of the 2 claims about Polysorbate 20 standing at each tier. Community volume is shown on the Consensus tab beside this and is never averaged into it.
Living evidence history
2 resolved citations, oldest to newest, coloured by tier. Retractions and contradictions land here as they are recorded.
Structure
No structure representation on record. PepJunkie draws only what an authoritative record supplies; for a peptide that is the residue sequence, and none has been curated for Polysorbate 20 yet.
Dose evidence, rung by rung
No established safe human dose. Nothing on file establishes one. That is a statement about the evidence PepJunkie holds, not a promise about the molecule.
Approved-label dose· a resolved regulatory document names a labelled dose
nothing resolved on this rung
Studied human doses· resolved human studies at the established tier
nothing resolved on this rung
Observational evidence· resolved human data at the emerging tier: thin, or contested
nothing resolved on this rung
Community-reported protocols· protocol propositions from distinct members, counted once per human
nothing resolved on this rung
Preclinical evidence· resolved animal, cell or mechanistic work
Polysorbate 20 Degradation in Biopharmaceutical Formulations: Quantification of Free Fatty Acids, Characterization of Particulates, and Insights into the Degradation Mechanism. · pmid 26419339 · 2015
Residual Host Cell Protein Promotes Polysorbate 20 Degradation in a Sulfatase Drug Product Leading to Free Fatty Acid Particles. · pmid 27032893 · 2016
2 resolved citations, 0 unresolved (an unresolved citation lends nothing). Community volume is its own rung and is never averaged into the evidence rungs.
Negative findings
failure is information
Nobody has filed a failure yet. Failures are information; this list is waiting for an honest one.