Approaches to Quality Risk Management When Using Single-Use Systems in the Manufacture of Biologics

作者：Ishii Watabe Akiko^*; Hirose Akihiko; Katori Noriko; Hashii Norikata; Arai Susumu; Awatsu Hirotoshi; Eiza Akira; Hara Yoshiaki; Hattori Hideshi; Inoue Tomomi; Isono Tetsuya; Iwakura Masahiro; Kajihara Daisuke; Kasahara Nobuo; Matsuda Hiroyuki; Murakami Sei; Nakagawa Taishiro; Okumura Takehiro; Omasa Takeshi; Takuma Shinya; Terashima Iyo; Tsukahara Masayoshi; Tsutsui Maiko; Yano Takahiro; Kawasaki Nana

来源：AAPS PHARMSCITECH, 2015, 16(5): 993-1001.

DOI：10.1208/s12249-015-0368-z

• biologics
• manufacturing technology
• quality risk management
• regulatory science
• single-use system

Biologics manufacturing technology has made great progress in the last decade. One of the most promising new technologies is the single-use system, which has improved the efficiency of biologics manufacturing processes. To ensure safety of biologics when employing such single-use systems in the manufacturing process, various issues need to be considered including possible extractables/leachables and particles arising from the components used in single-use systems. Japanese pharmaceutical manufacturers, together with single-use suppliers, members of the academia and regulatory authorities have discussed the risks of using single-use systems and established control strategies for the quality assurance of biologics. In this study, we describe approaches for quality risk management when employing single-use systems in the manufacturing of biologics. We consider the potential impact of impurities related to single-use components on drug safety and the potential impact of the single-use system on other critical quality attributes as well as the stable supply of biologics. We also suggest a risk-mitigating strategy combining multiple control methods which includes the selection of appropriate single-use components, their inspections upon receipt and before releasing for use and qualification of single-use systems. Communication between suppliers of single-use systems and the users, as well as change controls in the facilities both of suppliers and users, are also important in risk-mitigating strategies. Implementing these control strategies can mitigate the risks attributed to the use of single-use systems. This study will be useful in promoting the development of biologics as well as in ensuring their safety, quality and stable supply.

• 出版日期2015-10