Approaches to Quality Risk Management When Using Single-Use Systems in the Manufacture of Biologics.
Ishii-Watabe A, Hirose A, Katori N, Hashii N, Arai S, Awatsu H, Eiza A, Hara Y, Hattori H, Inoue T, Isono T, Iwakura M, Kajihara D, Kasahara N, Matsuda H, Murakami S, Nakagawa T, Okumura T, Omasa T, Takuma S, Terashima I, Tsukahara M, Tsutsui M, Yano T, Kawasaki N.
Ishii-Watabe A, et al. Among authors: yano t.
AAPS PharmSciTech. 2015 Oct;16(5):993-1001. doi: 10.1208/s12249-015-0368-z. Epub 2015 Aug 20.
AAPS PharmSciTech. 2015.
PMID: 26288941
Free PMC article.