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Abstract: Monoclonal antibody disulfide bonds reduction has been a common issue in biopharmaceutical process, which could produce low-molecular weight fragments, affect product quality, and lead to decreased protein purity and stability. Moreover, it could also affect the safety and effectiveness of drugs. Antibody disulfide bonds reduction is a reversible redox reaction caused by intracellular thioredoxin system and glutathione system, and is related to the specific production process. In recent years, with the development of antibody drugs and mammalian cell culture scale, disulfide bonds reduction is observed more frequently. To solve this problem, scientists have been constantly developing mitigation strategies to ensure the product quality. In this paper, the antibody disulfide bonds structure, cause of disulfide bonds reduction and influencing factors in manufacturing process were summarized. It is focused on the prevention methods in the manufacturing process. Additionally, several feasible process analysis techniques are listed so as to provide reference for the further development of monoclonal antibody drugs in manufacturing.
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