Stability assessment of antibody-drug conjugate Trastuzumab emtansine in comparison to parent monoclonal antibody using orthogonal testing protocol-Reference-Cited by-同舟云学术

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Stability assessment of antibody-drug conjugate Trastuzumab emtansine in comparison to parent monoclonal antibody using orthogonal testing protocol

Published:2018-02 Issue: Volume:150 Page:268-277
ISSN:0731-7085
Container-title:Journal of Pharmaceutical and Biomedical Analysis
language:en
Short-container-title:Journal of Pharmaceutical and Biomedical Analysis

Author:

Mohamed Hoda E.,Mohamed Abeer A.,Al-Ghobashy Medhat A.,Fathalla Faten A.,Abbas Samah S.

Publisher

Elsevier BV

Subject

Clinical Biochemistry,Spectroscopy,Drug Discovery,Pharmaceutical Science,Analytical Chemistry

Reference48 articles.

1. Quantification of an intact monoclonal antibody rituximab, by (RP) HPLC/DAD in compliance with ICH guidelines;Navas;Anal. Bioanal. Chem.,2013

2. Comprehensive two-dimensional liquid chromatography of therapeutic monoclonal antibody digests;Vanhoenacker;Anal. Bioanal. Chem.,2015

3. Commercial manufacturing scale formulation and analytical characterization of therapeutic recombinant antibodies;Harris;Drug Dev. Res.,2004

4. Study and ICH validation of a reverse-phase liquid chromatographic method for the quantification of the intact monoclonal antibody cetuximab;Martínez-Ortega;J. Pharm. Anal.,2016

5. Quality control and stability studies with the monoclonal antibody, trastuzumab: application of 1D-vs. 2D-gel electrophoresis;Nebija;Int. J. Mol. Sci.,2014

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