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Edetate Disodium as a Polysorbate Degradation and Monoclonal Antibody Oxidation Stabilizer

Edetate Disodium as a Polysorbate Degradation and Monoclonal Antibody Oxidation Stabilizer

Melissa Yarbrough, Tamara Hodge, Daniele Menard, Richard Jerome, Jeff Ryczek, David Moore, Phoebe Baldus, Nick Warne, Satoshi Ohtake

J Pharm Sci. 2019 Apr;108(4):1631-1635.

PMID: 30502482

Abstract:

Polysorbates are frequently used in biotherapeutic formulations. Interest in assessing their stability, in particular the impact of their degradation products on the stability of therapeutic proteins, has been steadily growing in the past decade. The work presented summarizes a case study of a monoclonal antibody formulation that demonstrated a simultaneous loss of polysorbate and an increase in methionine oxidation. Spiking studies were conducted to determine both the cause and a potential mitigation for the monoclonal antibody (mAb) oxidation and polysorbate 80 (PS80) loss. The results indicated that a different source material exhibited different rates of mAb oxidation and PS80 loss and that in all evaluated materials, the addition of edetate disodium to the formulation mitigated both observed issues. The mAb was assessed for the presence of lipases and lipoprotein lipase was detected at low levels. It is proposed that edetate disodium was effective in mitigating the mAb oxidation and PS80 loss by chelating calcium in the formulation and therefore decreasing the activity of the lipases.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
AP6381926-A	Edetate disodium		6381-92-6	Price

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