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Prediction of reversible IgG1 aggregation occurring in a size exclusion chromatography column is enabled through a model based approach

Ojala, Frida LU ; Sellberg, Anton LU ; Budde Hansen, Thomas; Broberg Hansen, Ernst and Nilsson, Bernt LU (2015) In Biotechnology Journal 10(11). p.1814-1821
Abstract
One important aspect of antibody separation being studied today is aggregation, as this not only leads to a loss in yield, but aggregates can also be hazardous if injected in to the body. The aim of the study was to determine whether the methodology applied in the previous study could be used to predict the aggregation of a different batch of IgG1, and to model the aggregation occurring in a SEC column. Aggregation was found to be reversible. The equilibrium parameter was found to be 272 M(-1) and the reaction kinetic parameter 1.33·10(-5) s(-1) , both within the 95%percnt; confidence interval of the results obtained in the previous work. The effective diffusivities were estimated to be 1.45·10(-13) and 1.90·10(-14) m(2) /s for the... (More)
One important aspect of antibody separation being studied today is aggregation, as this not only leads to a loss in yield, but aggregates can also be hazardous if injected in to the body. The aim of the study was to determine whether the methodology applied in the previous study could be used to predict the aggregation of a different batch of IgG1, and to model the aggregation occurring in a SEC column. Aggregation was found to be reversible. The equilibrium parameter was found to be 272 M(-1) and the reaction kinetic parameter 1.33·10(-5) s(-1) , both within the 95%percnt; confidence interval of the results obtained in the previous work. The effective diffusivities were estimated to be 1.45·10(-13) and 1.90·10(-14) m(2) /s for the monomers and dimers, respectively. Good agreement was found between the new model and the chromatograms obtained in the SEC experiments. The model was also able to predict the decrease of dimers due to the dilution and separation in the SEC column during long retention times. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Biotechnology Journal
volume
10
issue
11
pages
1814 - 1821
publisher
John Wiley & Sons
external identifiers
  • pmid:26212800
  • wos:000365129600017
  • scopus:84947025358
ISSN
1860-6768
DOI
10.1002/biot.201500160
language
English
LU publication?
yes
id
c5b8f31c-4a61-450c-9c0a-8929fffe903b (old id 7720666)
date added to LUP
2015-09-10 14:50:17
date last changed
2017-09-03 03:26:53
@article{c5b8f31c-4a61-450c-9c0a-8929fffe903b,
  abstract     = {One important aspect of antibody separation being studied today is aggregation, as this not only leads to a loss in yield, but aggregates can also be hazardous if injected in to the body. The aim of the study was to determine whether the methodology applied in the previous study could be used to predict the aggregation of a different batch of IgG1, and to model the aggregation occurring in a SEC column. Aggregation was found to be reversible. The equilibrium parameter was found to be 272 M(-1) and the reaction kinetic parameter 1.33·10(-5) s(-1) , both within the 95%percnt; confidence interval of the results obtained in the previous work. The effective diffusivities were estimated to be 1.45·10(-13) and 1.90·10(-14) m(2) /s for the monomers and dimers, respectively. Good agreement was found between the new model and the chromatograms obtained in the SEC experiments. The model was also able to predict the decrease of dimers due to the dilution and separation in the SEC column during long retention times.},
  author       = {Ojala, Frida and Sellberg, Anton and Budde Hansen, Thomas and Broberg Hansen, Ernst and Nilsson, Bernt},
  issn         = {1860-6768},
  language     = {eng},
  number       = {11},
  pages        = {1814--1821},
  publisher    = {John Wiley & Sons},
  series       = {Biotechnology Journal},
  title        = {Prediction of reversible IgG1 aggregation occurring in a size exclusion chromatography column is enabled through a model based approach},
  url          = {http://dx.doi.org/10.1002/biot.201500160},
  volume       = {10},
  year         = {2015},
}