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Mechanistic studies on the roles of metals and excipients in the oxidative degradation of proteins and surfactants
Wu, Yaqi
Wu, Yaqi
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Abstract
Therapeutic proteins have experienced significant growth over the past decade, becoming essential in the treatment of various diseases, including cancer, autoimmune disorders, and infections. However, these proteins are susceptible to degradation due to various stresses encountered during manufacturing, shipping, storage, and administration, ultimately compromising their efficacy and safety. To enhance their stability, proteins are often formulated with excipients, such as buffers and surfactants; yet, these components may also undergo degradation under certain conditions, leading to a loss of stabilizing effects and the formation of reactive byproducts, which further contribute to protein instability. This dissertation investigates the degradation of proteins and surfactants (e.g., polysorbate 80), with a focus on the effects of light exposure and metal impurities in formulations, providing insight into the mechanisms of degradation and potential strategies for stabilization.
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2025-01-01
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University of Kansas
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Keywords
Metal-induced oxidation, Oxidative degradation, Photo-degradation, Protein formulation, Protein oxidation, PS80 oxidation