Precision and robustness of 2D-NMR for structure assessment of filgrastim biosimilars-Reference-Cited by-同舟云学术

Precision and robustness of 2D-NMR for structure assessment of filgrastim biosimilars

Published:2016-02 Issue:2 Volume:34 Page:139-141
ISSN:1087-0156
Container-title:Nature Biotechnology
language:en
Short-container-title:Nat Biotechnol

Author:

Ghasriani Houman,Hodgson Derek J,Brinson Robert G,McEwen Ian,Buhse Lucinda F,Kozlowski Steven,Marino John P,Aubin Yves,Keire David A

Publisher

Springer Science and Business Media LLC

Subject

Biomedical Engineering,Molecular Medicine,Applied Microbiology and Biotechnology,Bioengineering,Biotechnology

Link

http://www.nature.com/articles/nbt.3474.pdf

Reference10 articles.

1. Health Canada. Guidance for sponsors: information and submission requirements for subsequent entry biologics (SEBs) (publication 2010/03/05) (Health Canada Publications, 2010).

2. EMEA. Comparability of biotechnological/biological products subject to changes in their manufacturing process (CPMP/ICH/5721/03) (European Medicines Agency, 2006).

3. US Food and Drug Administration. Guidance for industry: quality considerations in demonstrating biosimilarity to a reference protein product (UCM291134) (US FDA Office of Communications, 2012).

4. US FDA. Guidance for industry: scientific considerations in demonstrating biosimilarity to a reference product (UCM291128) (US FDA Office of Communications, 2012).

5. Gabrielson, J.P. & Weiss, W.F. 4th. J. Pharm. Sci. 104, 1240–1245 (2015).

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