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

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