Continuous chromatography is a promising technology for antibody production,which has significant advantages of improving process productivity,saving operation cost and enhancing product quality.However,continuous chromatography modes are diverse and there are many influencing factors,making traditional experiment-based process development methods difficult.In this study,model-assisted process development and optimization method was proposed and applied to continuous capture of monoclonal antibody.Different continuous capture modes(twin columns,three columns and four columns)were compared systematically,and the best mode and operating conditions were determined and further verified by experiments.It was found that the model prediction was consistent with the experimental results.Compared with batch chromatography,process productivity of continuous capture was increased by 27.2％,and the resin capacity utilization was increased by 50.1％.Moreover,there were no significant changes in product quality.The results demonstrated that model-assisted process development is useful to determine the optimal operating mode and conditions for continuous capture,promote process optimization,and accelerate the industrial applications of continuous process.
关键词
连续流层析/抗体捕获/模型辅助方法/蛋白A亲和层析/过程开发
Key words
continuous chromatography/antibody capture/model-assisted/protein A affinity chromatography/process development
维普
万方数据