Impact of Primary Container Closure System on PS80 Oxidation and the Mechanistic Understanding.

Purpose: Polysorbate oxidation can potentially lead to protein degradation and loss of potency, which has been a challenge for the pharmaceutical industry for decades. Many factors have been reported to impact polysorbate oxidation rate, including types of elemental impurities, peroxide content, pH, light exposure, grades of polysorbate, etc. Even though there are many publications in this field, the impact of primary container closure system on PS80 oxidation has not been systematically studied or reported.