Analysis of filtration behavior using integrated column chromatography followed by virus filtration.

Biotechnol Bioeng

Bioprocess Division, Department of Technology, Asahi Kasei Medical Co., Ltd., Nobeoka-shi, Miyazaki-ken, Japan.

Published: September 2021

We evaluated filtration behavior and virus removal capability for a monoclonal antibodies (mAb) and plasma IgG under constant flow rate directly following flow-through column chromatography in an integrated process. mAb solution with quantified host cell protein (HCP) content processed in flow-through mode on in-series mixed-mode AEX and modified CEX columns connected to the Planova BioEX filter (pool-less) achieved HCP logarithmic reduction value (LRV) of 2.3 and 93.9% protein recovery, demonstrating comparable or higher HCP LRV with high protein recovery compared to previous reports. For 5-15 mg/ml plasma IgG run to 100 L/m , similar filtration behavior was achieved for flux of 10-100 LMH, and lower flux runs remained well below the maximum operating pressure, suggesting that higher throughput in continuous processing is achievable. Comparison of fit of plasma IgG and mAb filtration behavior to four blocking models showed little differences but slightly better fit to the cake filtration model. Viral clearance of the filtration step tested by in-line spiking X-MuLV or MVM into purified plasma IgG following the chromatography step showed robust removal at low flux. Integrating the Planova BioEX filter into continuous processes with column chromatography can achieve efficient downstream processing with reduced footprint and process time.

Download full-text PDF

Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8453883PMC
http://dx.doi.org/10.1002/bit.27840DOI Listing

Publication Analysis

Top Keywords

filtration behavior
16
plasma igg
16
column chromatography
12
planova bioex
8
bioex filter
8
protein recovery
8
filtration
6
analysis filtration
4
behavior
4
behavior integrated
4

Similar Publications

Want AI Summaries of new PubMed Abstracts delivered to your In-box?

Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!