Ester Hydrolysis of Polysorbate 80 in mAb Drug Product: Evidence in Support of the Hypothesized Risk After the Observation of Visible Particulate in mAb Formulations
Author:
Funder
Janssen Research and Development
Publisher
Elsevier BV
Subject
Pharmaceutical Science
Reference40 articles.
1. Tween protects recombinant human growth hormone against agitation-induced damage via hydrophobic interactions;Bam;J Pharm Sci,1998
2. Surfactant–protein interaction;Randolph,2002
3. Polysorbates 20 and 80 used in the formulation for protein biotheraputics: Structure and degradation pathways;Kerwin;J Pharm Sci,2008
4. Compatibility, physical stability and characterization of an IgG4 monoclonal antibody after dilution into different intravenous administration bags;Kumru;J Pharm Sci,2012
5. Molecular origins of surfactant-mediated stabilization of protein drugs;Lee;Adv Drug Deliv Rev,2011
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