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Highly linear pH gradients for analyzing monoclonal antibody charge heterogeneity in the alkaline range: Validation of the method parameters.

Lingg, Nico; Berndtsson, Martina LU ; Hintersteiner, Beate; Schuster, Manfred; Bardor, Muriel and Jungbauer, Alois (2014) In Journal of Chromatography A 1373. p.124-130
Abstract
Cation exchange chromatography has been routinely used for the quantification of monoclonal antibody (mAb) charge heterogeneity. A previously developed method utilizing pH gradients for the elution instead of salt gradients was validated according to current guidelines proposed by the ICH. The linearity, stability, accuracy, precision and the lower limit of quantification have been determined, using pure charge variant standards. The method is valid for the quantification of mAb samples with a charge heterogeneity between 1% and 50%. Three different approaches to obtaining pure standard material for the validation of bio-analytical methods for the quantification of charge heterogeneity of IgG are presented. These methods are based on salt... (More)
Cation exchange chromatography has been routinely used for the quantification of monoclonal antibody (mAb) charge heterogeneity. A previously developed method utilizing pH gradients for the elution instead of salt gradients was validated according to current guidelines proposed by the ICH. The linearity, stability, accuracy, precision and the lower limit of quantification have been determined, using pure charge variant standards. The method is valid for the quantification of mAb samples with a charge heterogeneity between 1% and 50%. Three different approaches to obtaining pure standard material for the validation of bio-analytical methods for the quantification of charge heterogeneity of IgG are presented. These methods are based on salt gradient elution, pH gradient elution and displacement in cation exchange chromatography. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Journal of Chromatography A
volume
1373
pages
124 - 130
publisher
Elsevier
external identifiers
  • pmid:25465369
  • wos:000347265800015
  • scopus:84919389259
ISSN
0021-9673
DOI
10.1016/j.chroma.2014.11.021
language
English
LU publication?
yes
id
4861dc0d-ac1d-4460-b359-b38094fbec41 (old id 4912850)
date added to LUP
2015-01-22 12:26:22
date last changed
2017-11-19 03:07:50
@article{4861dc0d-ac1d-4460-b359-b38094fbec41,
  abstract     = {Cation exchange chromatography has been routinely used for the quantification of monoclonal antibody (mAb) charge heterogeneity. A previously developed method utilizing pH gradients for the elution instead of salt gradients was validated according to current guidelines proposed by the ICH. The linearity, stability, accuracy, precision and the lower limit of quantification have been determined, using pure charge variant standards. The method is valid for the quantification of mAb samples with a charge heterogeneity between 1% and 50%. Three different approaches to obtaining pure standard material for the validation of bio-analytical methods for the quantification of charge heterogeneity of IgG are presented. These methods are based on salt gradient elution, pH gradient elution and displacement in cation exchange chromatography.},
  author       = {Lingg, Nico and Berndtsson, Martina and Hintersteiner, Beate and Schuster, Manfred and Bardor, Muriel and Jungbauer, Alois},
  issn         = {0021-9673},
  language     = {eng},
  pages        = {124--130},
  publisher    = {Elsevier},
  series       = {Journal of Chromatography A},
  title        = {Highly linear pH gradients for analyzing monoclonal antibody charge heterogeneity in the alkaline range: Validation of the method parameters.},
  url          = {http://dx.doi.org/10.1016/j.chroma.2014.11.021},
  volume       = {1373},
  year         = {2014},
}