Large-scale monoclonal antibody purification by continuous chromatography, from process design to scale-up.

Abstract:

:The development and optimization of a purification process of monoclonal antibodies based on two continuous chromatography steps for capture and intermediate purification are presented. The two chromatography steps were individually optimized using either batch chromatography or sequential multicolumn chromatography (SMCC). Proprietary simulation software was used to optimize SMCC and to evaluate the potential gains compared with batch chromatography. The SMCC recipes provided by the simulation software were evaluated experimentally. A good correlation was found between the simulated results and experimental observations. Significant gains were observed on the productivity, buffer consumption and the volume of resin required for SMCC over batch chromatography. Based on these results, a chained process from the capture to polishing steps was implemented. This chained process demonstrated significantly better performance compared with the batch equivalent while satisfying the specifications. The expected positive impact provided by implementing continuous chromatography is also discussed.

journal_name

J Biotechnol

journal_title

Journal of biotechnology

authors

Girard V,Hilbold NJ,Ng CK,Pegon L,Chahim W,Rousset F,Monchois V

doi

10.1016/j.jbiotec.2015.04.026

subject

Has Abstract

pub_date

2015-11-10 00:00:00

pages

65-73

eissn

0168-1656

issn

1873-4863

pii

S0168-1656(15)00202-3

journal_volume

213

pub_type

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