Surfactants such as polysorbate 20 are commonly used to protect therapeutic proteins against stress occurring at the air-water interface.  However, it is well known that the level required to protect proteins from agitation-induced instability varies, and that polysorbates actually consist of a mixture of species and impurities that have the potential to impact protein stability over time.  In this work, the effect of buffer species and polysorbate 20 level on the stability of a monoclonal antibody (mAb) is examined under thermally stressed conditions.   In particular, it is shown that higher levels of polysorbate can have deleterious effects on mAb and excipient stability under particular formulation conditions.  These results provide significant insight into the dominant degradation mechanism of polysorbate at high temperatures and illustrate the complex relationship between high polysorbate levels, buffer species, excipient oxidation, and protein aggregation.

Impact of solution conditions on polysorbate oxidation and mAb stability

243rd National Meeting (2012)

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