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Scaleup of monoclonal antibody purification using radial streaming ion exchange chromatography
Author(s) -
Jungbauer A.,
Unterluggauer F.,
Uhl K.,
Buchacher A.,
Steindl F.,
Pettauer D.,
Wenisch E.
Publication year - 1988
Publication title -
biotechnology and bioengineering
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.136
H-Index - 189
eISSN - 1097-0290
pISSN - 0006-3592
DOI - 10.1002/bit.260320309
Subject(s) - monoclonal antibody , ion chromatography , chromatography , chemistry , ion exchange , antibody , ion , biology , immunology , organic chemistry
A scaleup study of the radial streaming chromatography (ZetaPrep technique) using hybridoma culture supernatant as model protein solution is described in this article. Lab and pilot cartridges were tested. Scaleup factors were calculated from the lab experiments and compared to the data obtained at pilot level. The procedure consists of three different steps: microfiltration, diafiltration, and the ZetaPrep technique using QAE cartridges. Diafiltration was used to condition the clarified culture supernatant. Calculating the elution volumes for the pilot level (ZetaPrep 800) from the smallest lab cartridge (ZetaPrep 15), a difference between calculated and experimental values of 230% was obtained. The difference between calculated and experimental values using results from ZetaPrep 100, a preparative cartridge, was 120%. At pilot level it is possible to purify 10 L culture supernatant within 3 h including regeneration and reequilibration of the cartridge. This procedure is useful for monoclonal antibodies (mAb) with a low isoelectric point (pl). The pl's of the mAb which was used in this work are in the range 5.4–6.1.