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

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DOI: 10.1208/s12249-015-0368-z
Published: 2015 Oct
Container: AAPS PharmSciTech
Publisher: Not recorded
Open access: yes

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Cite this work

BibTeX

@article{allodium:10.1208/s12249-015-0368-z,
  title = {Approaches to Quality Risk Management When Using Single-Use Systems in the Manufacture of Biologics.},
  author = {Ishii-Watabe A and Hirose A and Katori N and Hashii N and Arai S and Awatsu H and Eiza A and Hara Y and Hattori H and Inoue T and Isono T and Iwakura M and Kajihara D and Kasahara N and Matsuda H and Murakami S and Nakagawa T and Okumura T and Omasa T and Takuma S and Terashima I and Tsukahara M and Tsutsui M and Yano T and Kawasaki N},
  year = {2015},
  journal = {AAPS PharmSciTech},
  doi = {10.1208/s12249-015-0368-z},
  url = {https://doi.org/10.1208/s12249-015-0368-z}
}

RIS

TY  - JOUR
TI  - Approaches to Quality Risk Management When Using Single-Use Systems in the Manufacture of Biologics.
AU  - Ishii-Watabe A
AU  - Hirose A
AU  - Katori N
AU  - Hashii N
AU  - Arai S
AU  - Awatsu H
AU  - Eiza A
AU  - Hara Y
AU  - Hattori H
AU  - Inoue T
AU  - Isono T
AU  - Iwakura M
AU  - Kajihara D
AU  - Kasahara N
AU  - Matsuda H
AU  - Murakami S
AU  - Nakagawa T
AU  - Okumura T
AU  - Omasa T
AU  - Takuma S
AU  - Terashima I
AU  - Tsukahara M
AU  - Tsutsui M
AU  - Yano T
AU  - Kawasaki N
PY  - 2015
JO  - AAPS PharmSciTech
DO  - 10.1208/s12249-015-0368-z
UR  - https://doi.org/10.1208/s12249-015-0368-z
ER  -

APA

A, I., A, H., N, K., N, H., S, A., H, A., A, E., Y, H., H, H., T, I., T, I., M, I., D, K., N, K., H, M., S, M., T, N., T, O., T, O., S, T., I, T., M, T., M, T., T, Y., & N, K. (2015). Approaches to Quality Risk Management When Using Single-Use Systems in the Manufacture of Biologics.. AAPS PharmSciTech. https://doi.org/10.1208/s12249-015-0368-z

Source records

pubmed · retrieved 2026-09-27T11:27:12.793Z