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随着分子生物学技术的进步和抗体基因结构的阐明,以小分子抗体为基础并经基因工程改建从而用于研究和临床诊治的大量基因工程抗体片段应运而生。其中,可将生物学活性效应桥连于治疗靶标的双特异性抗体、同时增强抗体效能及细胞毒靶向性的免疫结合物、以独特的单域结构在生物技术和临床医学等方面倍受青睐的纳米抗体,以及在细胞内特定部位表达的细胞内抗体是近年来研究最活跃的几个领域。凭借免疫原性弱、组织渗透性强、低毒性及制备简便等优势,基因工程抗体片段较之单克隆抗体受到了更广泛的关注与认可。尽管大多数处于临床开发的抗体片段的安全性和有效性还有待确定,但基因工程抗体片段的研发必将大大提高人类疾病尤其是肿瘤的诊治水平。
With the progress of molecular biology technology and the elucidation of antibody gene structure, a large number of genetically engineered antibody fragments have emerged as small molecule antibodies and genetically engineered for research and clinical diagnosis and treatment. Among them, the biologically active effect can be bridged to the target of the bispecific antibody, while enhancing antibody potency and cytotoxic targeting immune conjugates with a unique single-domain structure in biotechnology and clinical medicine, etc. The favored nanobodies, as well as the intracellular antibodies expressed at specific sites in the cell, are among the most actively studied in recent years. With the advantages of weak immunogenicity, strong tissue permeability, low toxicity and easy preparation, genetically engineered antibody fragments have received more attention and recognition than monoclonal antibodies. Although the safety and efficacy of most antibody fragments in clinical development have yet to be determined, the development of genetically engineered antibody fragments will greatly improve the diagnosis and treatment of human diseases, especially tumors.