Real-time product attribute control to manufacture antibodies with defined N-linked glycan levels-Reference-Cited by-同舟云学术

Real-time product attribute control to manufacture antibodies with defined N-linked glycan levels

Published:2015-07-27 Issue:5 Volume:31 Page:1433-1441
ISSN:8756-7938
Container-title:Biotechnology Progress
language:en
Short-container-title:Biotechnol Progress

Author:

Zupke Craig¹,Brady Lowell J.¹,Slade Peter G.¹,Clark Philip¹,Caspary R. Guy¹,Livingston Brittney¹,Taylor Lisa¹,Bigham Kyle¹,Morris Arvia E.¹,Bailey Robert W.¹

Affiliation:

1. Product and Process Development; Amgen Inc.; 1201 Amgen Court West Seattle WA 98119

Publisher

Wiley

Subject

Biotechnology

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/btpr.2136/fullpdf

Reference25 articles.

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2. FDA http://www.fda.gov/downloads/Drugs/Guidances/ucm073517.pdf 2015

3. FDA http://www.fda.gov/downloads/Drugs/Guidances/ucm073507.pdf 2015

4. Pharmaceutical quality by design: product and process development, understanding, and control;Yu;Pharm Res,2008

5. Quality by design for biopharmaceuticals;Rathore;Nat Biotechnol,2009

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