抗体类生物治疗药物活性测定方法

Progress in Research and Development of Bioactivity Determination of Antibody-based Therapeutics

抗体类生物治疗药物的活性测定在质量控制中至关重要。目前抗体药物的活性分析方法主要是体外(in vitro)检测,其中基于细胞的分析方法由于其具有操作简便,周期短,特异性好,变异度小等优点得到广泛应用。为了获得反应性理想的细胞和简便易行的检测方法,构建转基因细胞成为目前常用的策略之一。此外,一些新型技术也快速应用于抗体类药物的活性评价中。结合抗体类生物治疗药物活性测定方法的现状以及发展趋势,主要从基于细胞、转基因细胞以及新技术应用三方面对抗体药物活性测定方法进行简要综述,为抗体药物的研发和质量控制提供新思路。

Bioactivity determination of antibody-based therapeutics is essential in quality control. Presently,the main method to determine bioactivity is in vitro assay. Cell-based determination is widely used because of its advantages,such as simple operation,short period,good specificity and small variation,etc. In order to obtain the cell lines with ideal reactivity and simple detection method,construction of transgenic cell lines become one of the common strategies. In addition,some new technologies have rapidly been applied to evaluate the bioactivity of antibody drugs. Combined with the current research status and trend in development of bioactivity determination method,three aspects of antibody bioassay methods,which are based on cells,genetically modified cells and new technologies were described,thus providing new ideas for drug development and quality control.