Edetate disodium (EDTA) is a chelating agent; in a monoclonal antibody formulation it mitigated both polysorbate 80 loss and methionine oxidation, proposed to act by chelating calcium and so reducing lipase activity.
Claim: Residue-specific impact of EDTA and methionine on protein oxidationstanding
resolved
Residue-Specific Impact of EDTA and Methionine on Protein Oxidation in Biotherapeutics Formulations Using an Integrated Biotherapeutics Drug Product Development Workflow.
Thakkar SV, Rodrigues D, Zhai B, Banton D, Somani S, Javidi A, Mahan A, Ember S, DeGrazio D, Ganguly S, Amin K, Nanda H
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
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