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Research

Polysorbate 20 — living evidence map

The Atlas page holds the claims; this is how its evidence evolved.

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

Polysorbate 20 Degradation in Biopharmaceutical Formulations: Quantification of Free Fatty Acids, Characterization of Particulates, and Insights into the Degradation Mechanism. (2015) · preclinicalResidual Host Cell Protein Promotes Polysorbate 20 Degradation in a Sulfatase Drug Product Leading to Free Fatty Acid Particles. (2016) · preclinical20152016

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.

  1. Approved-label dose · a resolved regulatory document names a labelled dose

    nothing resolved on this rung

  2. Studied human doses · resolved human studies at the established tier

    nothing resolved on this rung

  3. Observational evidence · resolved human data at the emerging tier: thin, or contested

    nothing resolved on this rung

  4. Community-reported protocols · protocol propositions from distinct members, counted once per human

    nothing resolved on this rung

  5. 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.