Highly linear pH gradients for analyzing monoclonal antibody charge heterogeneity in the alkaline range: Validation of the method parameters.
(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)
Please use this url to cite or link to this publication:
https://lup.lub.lu.se/record/4912850
- author
- Lingg, Nico ; Berndtsson, Martina LU ; Hintersteiner, Beate ; Schuster, Manfred ; Bardor, Muriel and Jungbauer, Alois
- organization
- publishing date
- 2014
- 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
- pmid:25465369
- 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
- 2016-04-01 10:14:08
- date last changed
- 2022-04-27 20:00:23
@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}},
doi = {{10.1016/j.chroma.2014.11.021}},
volume = {{1373}},
year = {{2014}},
}