シングルユースシステムを用いて製造されるバイオ医薬品の品質確保に関する提言

抄録

 The use of single-use systems has been getting more popular in biologics manufacturing. Utilization of this novel technology enables the efficient manufacturing, including prevention of cross contamination, flexibility to manufacture multiple products, and elimination of the need for cleaning and steam sterilization including those validations. In order to ensure the quality and stable supply of biologics, appropriate risk management considering the characteristics of the system is necessary. However, there is no regulatory document describing the examples or recommendations on it. In 2015, we published the White paper of “Approaches to Quality Risk Management When Using Single-Use Systems in the Manufacture of Biologics” in AAPS PharmSciTech, which was a fruit of discussion in the research group consisting of Japanese pharmaceutical manufacturers, single-use suppliers, academia and regulatory agencies. This review introduces the contents of the White paper with some revision reflecting the comments on it as well as the discussion in our research group after publishing the paper. The basic concept is consistent with ICH guideline on quality risk management. Here we describe the points to consider in risk assessment as well as in risk control when single-use systems are used in biologics manufacturing.