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单抗(MAb)产品包括用杂交瘤制备的完整免疫球蛋白、免疫交联物以及从免疫球蛋白中获得的免疫球蛋白碎片和重组蛋白。单抗类生物制品与化学药物的非临床安全性研究和评价方法明显不同,原因在于前者的结构和生物学性质具有专一性和多样性,包括种属特异性、免疫原性和无法预料的多种组织亲和性。本文根据作者在单抗类生物制品非临床安全性研究和审评中的体会,介绍该类产品的非临床安全性研究和评价的考虑要点,以供研发者参考。
Monoclonal antibody (MAb) products include intact immunoglobulins made with hybridomas, immunoconjugates, and immunoglobulin fragments and recombinant proteins obtained from immunoglobulins. The non-clinical safety studies and evaluation methods of monoclonal antibodies against biological and chemical drugs are significantly different because of the specificity and diversity of the structure and biological properties of the former, including species-specific, immunogenicity and unpredictable Multiple tissue affinity. Based on the author’s experience in the non-clinical safety research and review of monoclonal antibodies, this paper introduces the key points for non-clinical safety research and evaluation of such products for reference.