Journal ArticleDOI
Validation of a pH gradient-based ion-exchange chromatography method for high-resolution monoclonal antibody charge variant separations
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TLDR
A pH gradient-based separation method using cation exchange chromatography was shown to be robust for monoclonal antibodies and suitable for its intended purpose of charge heterogeneity analysis, demonstrating the superior precision and robustness of this multi-product method.About:
This article is published in Journal of Pharmaceutical and Biomedical Analysis.The article was published on 2011-01-25. It has received 92 citations till now. The article focuses on the topics: Ion chromatography & Isoelectric focusing.read more
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Journal ArticleDOI
Characterization of Therapeutic Antibodies and Related Products
Journal ArticleDOI
Chromatographic, Electrophoretic, and Mass Spectrometric Methods for the Analytical Characterization of Protein Biopharmaceuticals.
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Ion-exchange chromatography for the characterization of biopharmaceuticals
TL;DR: An overview of theoretical and practical aspects of modern IEX applied for the characterization of therapeutic proteins including monoclonal antibodies (Mabs) and antibody drug conjugates (ADCs).
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Method development for the separation of monoclonal antibody charge variants in cation exchange chromatography, Part II: pH gradient approach
TL;DR: It is proved that the mobile phase temperature was not relevant for tuning selectivity, while optimal salt gradient program can be easily found based on only two initial gradients of different slopes, and salt gradient CEX can be considered as a generic multi-product approach.
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Modern chromatographic and mass spectrometric techniques for protein biopharmaceutical characterization
TL;DR: The complexity of protein therapeutics is far exceeding that of small molecule drugs; hence, unraveling this complexity represents an analytical challenge as discussed by the authors, and a review provides the reader with state-of-the-art chromatographic and mass spectrometric tools available to dissect primary and higher order structures, post-translational modifications, purity and impurity profiles and pharmacokinetic properties.
References
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Journal ArticleDOI
Monoclonal antibody successes in the clinic
TL;DR: Most monoclonal antibodies in clinical trials are owned by small biotech companies, but with blockbuster-sized revenues and approval rates higher than those for small-molecule drugs, that all may be set to change.
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Development of validated stability-indicating assay methods--critical review.
Monika Bakshi,Saranjit Singh +1 more
TL;DR: This write-up provides a review on the development of validated stability-indicating assay methods (SIAMs) for drug substances and products and the shortcomings of reported methods with respect to regulatory requirements are highlighted.
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Heterogeneity of Monoclonal Antibodies
TL;DR: The current knowledge of enzymatic and nonenzymatic modifications of monoclonal antibodies including the common ones such as incomplete disulfide bond formation, glycosylation, N-terminal pyroglutamine cyclization, C- terminal lysine processing, deamidation, isomerization, and oxidation are reviewed.
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Heterogeneity of monoclonal antibodies revealed by charge-sensitive methods.
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