Stress-mediated polysorbate 20 degradation and its potential impact on therapeutic proteins
Baikuntha Aryal,
Mari Lehtimaki,
V. Ashutosh Rao
Abstract:Purpose
Polysorbates are the most commonly used surfactants in formulations to stabilize therapeutic proteins against interfacial stresses. Polysorbates can undergo oxidative or enzyme-mediated hydrolytic degradation to produce free fatty acids (FFAs) and subvisible particles in formulations. To determine which product related variables contribute to PS20 degradation, we investigated the effects of storage temperature, formulation, pH, presence of hydrolytic enzymes, and specific fatty acid compo… Show more
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