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Controlled polysorbate 20 hydrolysis – A new approach to assess the impact of polysorbate 20 degradation on biopharmaceutical product quality in shortened time
Hydrolysis of polysorbate in biopharmaceutical liquid formulations upon long-term storage represents a threat issue, since discount of the intact surfactant focus could compromise protein stability. Furthermore, accumulation of polysorbate degradation merchandise is related to the formation of particulates probably affecting…