Multicapillary SDS-gel electrophoresis for the analysis of fluorescently labeled mAb preparations: A high throughput quality control process for the production of QuantiPlasma and PlasmaScan mAb libraries

Molecular heterogeneity of mAb preparations is the result of various co‐ and post‐translational modifications and to contaminants related to the production process. Changes in molecular composition results in alterations of functional performance, therefore quality control and validation of therapeu...

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Bibliographic Details
Published in:Electrophoresis 2014-08, Vol.35 (15), p.2155-2162
Main Authors: Székely, Andrea, Szekrényes, Ákos, Kerékgyártó, Márta, Balogh, Attila, Kádas, János, Lázár, József, Guttman, András, Kurucz, István, Takács, László
Format: Article
Language:English
Subjects:
Alterations
Antibodies, Monoclonal - analysis
Antibodies, Monoclonal - chemistry
Capillary electrophoresis
Contaminants
Diagnostic systems
Electrophoresis
Electrophoresis, Polyacrylamide Gel - methods
Fluorescent Dyes - analysis
Glycoform
Glycoproteins - analysis
Glycoproteins - chemistry
Heterogeneity
High-Throughput Screening Assays - methods
High-Throughput Screening Assays - standards
Humans
Libraries
mAb proteomics
Peptide Library
Profiling
Quality Control
SDS
Serum Albumin
Serum Albumin, Human
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Summary:Molecular heterogeneity of mAb preparations is the result of various co‐ and post‐translational modifications and to contaminants related to the production process. Changes in molecular composition results in alterations of functional performance, therefore quality control and validation of therapeutic or diagnostic protein products is essential. A special case is the consistent production of mAb libraries (QuantiPlasma™ and PlasmaScan™) for proteome profiling, quality control of which represents a challenge because of high number of mAbs (>1000). Here, we devise a generally applicable multicapillary SDS‐gel electrophoresis process for the analysis of fluorescently labeled mAb preparations for the high throughput quality control of mAbs of the QuantiPlasma™ and PlasmaScan™ libraries.
ISSN:0173-0835
1522-2683
DOI:10.1002/elps.201400208