Particulate matter can indicate potential quality problems and immunogenic risks of injections,so as to be a necessary indicator for injection evaluation in the quality management.Microflow digital imaging(MDI)is a new technology for detecting particulate matter.Compared with the light obscuration method,which is the"gold standard"for particulate matter analysis,MDI can not only provide the detailed information on the size and quantity of particles,but also obtain the type and shape characteristics through high-resolution images.In addition,MDI requires a small sample volume and is especially suitable for the quality analysis of protein drug injections.From prospects of the formation causes of particulate matter and the technical requirements of drug regulatory agencies and pharmacopoeias in various countries for the quality control of particulate matter in injections,this paper reviews the application progress of MDI technology in formulation development and process research of protein drugs,in order to ensure the safety and efficacy of protein drug formulations.
关键词
蛋白药物/注射剂/不溶性微粒/微流数字成像/质量控制
Key words
protein drug/injection/particulate matter/microflow digital imaging/quality control
维普
万方数据