Approaches to Quality Risk Management When Using Single-Use Systems in the Manufacture of Biologics
Journal Title: AAPS PharmSciTech - Year 2015, Vol 16, Issue 5
Abstract
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.
Authors and Affiliations
Akiko Ishii-Watabe, Akihiko Hirose, Noriko Katori, Norikata Hashii, Susumu Arai, Hirotoshi Awatsu, Akira Eiza, Yoshiaki Hara, Hideshi Hattori, Tomomi Inoue, Tetsuya Isono, Masahiro Iwakura, Daisuke Kajihara, Nobuo Kasahara, Hiroyuki Matsuda, Sei Murakami, Taishiro Nakagawa, Takehiro Okumura, Takeshi Omasa, Shinya Takuma, Iyo Terashima, Masayoshi Tsukahara, Maiko Tsutsui, Takahiro Yano, Nana Kawasaki
Keywords
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