High-throughput process development technology for design of cleaning-in-place (CIP) protocols for chromatography media

Grönberg, Anna; Johansson, Hans J.; Eriksson, Kjell; Carredano, Enrique

doi:10.1016/j.drudis.2011.10.017

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“…7 MabSelect, based on recombinant Protein A, which is less stable in alkaline conditions compared with MabSelect SuRe, benefits from a twostep CIP protocol using 100 mM reducing agent followed by 15 mM NaOH. 8,9 Manual or automated workflow. Fouling of resin and screening of cleaning conditions can be done in a manual workflow using multi-pipettes and manual centrifugation or vacuum filtration.…”

Section: Methodsmentioning

confidence: 99%

“…Several studies have proved that the correlation between the scaleddown, 96-well format and traditional columns is good. [6][7][8][9] For MabSelect SuRe, a CIP using 0.1 M NaOH at a contact time of 15 min gives efficient cleaning in a mAb process, and enables use of the column for at least 150 cycles. 6 More challenging feeds can benefit from a two-step CIP protocol using 100 mM reducing agent followed by 0.1 M NaOH on MabSelect SuRe.…”

Section: Methodsmentioning

confidence: 99%

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