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 Biotechnoljournal_title
Journal of biotechnologyauthors
Girard V,Hilbold NJ,Ng CK,Pegon L,Chahim W,Rousset F,Monchois Vdoi
10.1016/j.jbiotec.2015.04.026subject
Has Abstractpub_date
2015-11-10 00:00:00pages
65-73eissn
0168-1656issn
1873-4863pii
S0168-1656(15)00202-3journal_volume
213pub_type
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