Risk Assessment And Control Of Single-Use Systems During PD-1 Monoclonal Antibody Production For SuZhou XX Company

Single-use systems have been widely used in biopharmaceutical fields like monoclonal antibody production.Although single-use systems have many advantages,there are still potential quality management risks due to their inherent materials,production and processing technology and use modes.Suzhou XX company plans to apply single-use systems in monoclonal antibody production.Inevitably,there will be great risks.In addtion,few application cases of risk point assessment and risk control for single-use systems in biopharmaceutical production process have been reported.Therefore,it is urgent to study the risk assessment and control of this project.Taking the production process of monoclonal antibody(PD-1)from SuZhou XX Company as an example,risk points of single-use systems in the production of monoclonal antibody as well as production equipment and facilities were systematically and integrally identified,analyzed and evaluated based on the requirements of Chinese and oversea GMP and other applicable regulations by using failure mode and effects analysis(FMEA).Relevant solutions of each risk point of medium or high level were proposed for developing risk control measure.A total of 15 items(24 sub-items)were identified,of which 1 sub-item had low level risk,19 sub-items medium level and 4 sub-items high level.After developing control measures for risks of medium and high level,re-assessment was carried out.It was found that the established risk control measures could reduce each risk point to an acceptable level.The research in this paper provides a good reference for strengthening the quality risk management of single-use systems.