Abstract:

Biopharmaceuticals have achieved increasingly significant therapeutic effects in the treatment of tumors， autoimmune diseases and other complex diseases. However， there is a risk of immunogenicity when using biopharmaceuticals for treatment， which can reduce drug efficacy and affect treatment outcomes， even cause severe adverse reactions. Reducing or eliminating the immunogenicity of biopharmaceuticals on the basis of maintaining their pharmacokinetic properties and therapeutic efficacy has become an important aspect of the drug development process. Understanding the complex mechanisms driving the immunogenicity of biopharmaceuticals and developing effective strategies to reduce immunogenicity risks are crucial for improving drug efficacy and safety. The article reviewed the development of mechanism of immunogenicity in biopharmaceuticals， discussed the factors that affected immunogenicity and focused on strategies used to reduce immunogenicity in drug development， in order to provide a reference for the research and development of biopharmaceuticals.

Key words: biopharmaceuticals, immunogenicity, anti?drug antibody, chemical modification, aggregation

摘要：

生物技术药物在肿瘤、自身免疫性疾病及其他复杂疾病的治疗中取得了日益显著的治疗效果。使用生物技术药物进行治疗时存在免疫原性风险，导致药物疗效和治疗效果降低，甚至产生严重的不良反应。在保持生物技术药物药代动力学特性和治疗效果的基础上，降低或去除其免疫原性成为药物开发过程的重要环节。了解驱动生物技术药物免疫原性的复杂机制以及制定有效的策略降低免疫原性风险对于提高药物疗效和安全性至关重要。综述了生物技术药物免疫原性产生机制的研究进展，讨论了影响免疫原性的因素，重点阐述了在药物开发过程中降低免疫原性的策略，以期为生物技术药物的研发提供参考。

关键词: 生物技术药物, 免疫原性, 抗药物抗体, 化学修饰, 聚集