Determination of critical quality attributes for monoclonal antibodies using quality by design principles-Reference-Cited by-同舟云学术

Determination of critical quality attributes for monoclonal antibodies using quality by design principles

Published:2016-09 Issue:5 Volume:44 Page:291-305
ISSN:1045-1056
Container-title:Biologicals
language:en
Short-container-title:Biologicals

Author:

Alt Nadja,Zhang Taylor Y.,Motchnik Paul,Taticek Ron,Quarmby Valerie,Schlothauer Tilman,Beck Hermann,Emrich Thomas,Harris Reed J.

Publisher

Elsevier BV

Subject

Pharmacology,General Immunology and Microbiology,Applied Microbiology and Biotechnology,General Medicine,Bioengineering,Biotechnology

Reference56 articles.

1. A-MAb: a case study in bioprocess development;CMC Biotech Working Group,2009

2. ICH harmonized tripartite guideline, pharmaceutical development;International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use,2009

3. Introduction to the application of QbD principles for the development of monoclonal antibodies;Lynne;Biologicals,2016

4. Modulation of therapeutic antibody effector functions by glycosylation engineering: influence of Golgi enzyme localization domain and co-expression of heterologous beta1, 4-N-acetylglucosaminyltransferase III and Golgi alphamannosidase II;Ferrara;Biotechnol Bioeng,2006

5. Assessment of chemical modifications of sites in the CDRs of recombinant antibodies: susceptibility vs. functionality of critical quality attributes;Haberger;MAbs,2014

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