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

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 manu...

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Detalles Bibliográficos
Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer US 2015
Materias:
White Paper
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4674654/
https://www.ncbi.nlm.nih.gov/pubmed/26288941
http://dx.doi.org/10.1208/s12249-015-0368-z

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4674654/
https://www.ncbi.nlm.nih.gov/pubmed/26288941
http://dx.doi.org/10.1208/s12249-015-0368-z

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