Next Article in Journal
Comparative Study of Electroless Copper Film on Different Self-Assembled Monolayers Modified ABS Substrate
Next Article in Special Issue
Functional Identification of Proteus mirabilis eptC Gene Encoding a Core Lipopolysaccharide Phosphoethanolamine Transferase
Previous Article in Journal
ADMA/SDMA in Elderly Subjects with Asymptomatic Carotid Atherosclerosis: Values and Site-Specific Association
Previous Article in Special Issue
Cadmium Toxicity Induced Alterations in the Root Proteome of Green Gram in Contrasting Response towards Iron Supplement
Article Menu

Export Article

Open AccessArticle
Int. J. Mol. Sci. 2014, 15(4), 6399-6411;

Quality Control and Stability Studies with the Monoclonal Antibody, Trastuzumab: Application of 1D- vs. 2D-Gel Electrophoresis

Department of Pharmaceutical Chemistry, Medical Faculty, Rr. Bulevardi i Deshmoreve, n.n. 10000 Pristina, Kosovo
Department of Pharmaceutical Chemistry, Faculty of Life Sciences, University of Vienna, Althanstrasse 14, 1090 Vienna, Austria
Author to whom correspondence should be addressed.
Received: 19 December 2013 / Revised: 10 March 2014 / Accepted: 31 March 2014 / Published: 15 April 2014
(This article belongs to the Collection Advances in Proteomic Research)
Full-Text   |   PDF [2441 KB, uploaded 19 June 2014]


Recombinant monoclonal antibodies (rmAbs) are medicinal products obtained by rDNA technology. Consequently, like other biopharmaceuticals, they require the extensive and rigorous characterization of the quality attributes, such as identity, structural integrity, purity and stability. The aim of this work was to study the suitability of gel electrophoresis for the assessment of charge heterogeneity, post-translational modifications and the stability of the therapeutic, recombinant monoclonal antibody, trastuzumab. One-dimensional, SDS-PAGE, under reducing and non-reducing conditions, and two-dimensional gel electrophoresis were used for the determination of molecular mass (Mr), the isoelectric point (pI), charge-related isoform patterns and the stability of trastuzumab, subjected to stressed degradation and long-term conditions. For the assessment of the influence of glycosylation in the charge heterogeneity pattern of trastuzumab, an enzymatic deglycosylation study has been performed using N-glycosidase F and sialidase, whereas carboxypeptidase B was used for the lysine truncation study. Experimental data documented that 1D and 2D gel electrophoresis represent fast and easy methods to evaluate the quality of biological medicinal products. Important stability parameters, such as the protein aggregation, can be assessed, as well. View Full-Text
Keywords: trastuzumab; 2D-electophoresis; SDS-PAGE; charge heterogeneity; stability trastuzumab; 2D-electophoresis; SDS-PAGE; charge heterogeneity; stability
This is an open access article distributed under the Creative Commons Attribution License (CC BY 3.0).

Share & Cite This Article

MDPI and ACS Style

Nebija, D.; Noe, C.R.; Urban, E.; Lachmann, B. Quality Control and Stability Studies with the Monoclonal Antibody, Trastuzumab: Application of 1D- vs. 2D-Gel Electrophoresis. Int. J. Mol. Sci. 2014, 15, 6399-6411.

Show more citation formats Show less citations formats

Related Articles

Article Metrics

Article Access Statistics



[Return to top]
Int. J. Mol. Sci. EISSN 1422-0067 Published by MDPI AG, Basel, Switzerland RSS E-Mail Table of Contents Alert
Back to Top