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Peptide Atlas · Excipient

Polysorbate 20

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.

What the evidence says

six tiers, never blended

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.

    • preclinical
      Claim: Polysorbate 20 degradation: free fatty acids and particles standing
    • resolved

    Polysorbate 20 Degradation in Biopharmaceutical Formulations: Quantification of Free Fatty Acids, Characterization of Particulates, and Insights into the Degradation Mechanism.

    Tomlinson A, Demeule B, Lin B, Yadav S

    pmid 26419339

    • preclinical
      Claim: Host cell protein promotes polysorbate 20 degradation standing
    • resolved

    Residual Host Cell Protein Promotes Polysorbate 20 Degradation in a Sulfatase Drug Product Leading to Free Fatty Acid Particles.

    Dixit N, Salamat-Miller N, Salinas PA, Taylor KD, Basu SK

    pmid 27032893

A claim's standing is its latest row in an append-only history; a tombstone names the later evidence and the reason. The Graveyard and the Resurrection Yard.

Negative findings

failure is information

Nobody has filed a failure yet. Failures are information; this list is waiting for an honest one.