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融合蛋白技术应用于生物制药行业已超过25年,其目的为改善原来天然蛋白的性质,从而具有新的理化特征和生物学功能,其中最为显著的特点是改善了小分子蛋白及多肽半衰期短的缺陷。基于该技术所诞生的融合蛋白类药物已成为当前生物药研发的热点。结合已上市融合蛋白类药物,通过与传统多肽蛋白类药物比较,重点突出融合蛋白类药物自身特点,主要从融合抗体Fc段和人血清白蛋白以延长小分子蛋白及多肽半衰期的角度对融合蛋白药物长效化策略进行评述;对融合蛋白类药物在体内的吸收、分布、代谢和排泄的显著特征进行概述;综述该类药物在体内的分析技术并指出当前分析技术的优缺点及发展方向,为长效化融合蛋白药物的设计、分析研究与开发提供依据和思路。
The fusion protein technology has been applied to the biopharmaceutical industry for more than 25 years. Its purpose is to improve the properties of the original natural protein so as to have new physicochemical characteristics and biological functions. The most prominent feature of this fusion protein is to improve the short half-life of small molecule proteins and peptides defect. The fusion protein drugs based on this technology have become a hot spot in the research and development of biopharmaceuticals. In combination with the commercially available fusion protein drugs, the fusion proteins are mainly focused on the characteristics of the fusion protein drugs by comparing with the traditional polypeptide protein drugs, mainly from the perspective of the fusion of the Fc region of the antibody and the human serum albumin to prolong the half-life of the small molecule protein and polypeptide Reviews the long-acting strategy of drugs; summarizes the salient features of the absorption, distribution, metabolism and excretion of fusion proteins in the body; summarizes the analysis techniques of the drugs in vivo and points out the advantages, disadvantages and development directions of the current analysis techniques, For the long-term fusion protein drug design, analysis and research provide the basis and ideas.