期刊
BIOTECHNOLOGY JOURNAL
卷 12, 期 12, 页码 -出版社
WILEY-V C H VERLAG GMBH
DOI: 10.1002/biot.201700260
关键词
monoclonal antibodies; multimode chromatography; process design; process economics
资金
- FCT - Fundacao para a Ciencia e a Tecnologia [PTDC/QEQ-PRS/0286/2014, research unit iBB UID/BIO/04565/2013, IF/00048/2014/CP1214/CT0010]
- European Union [312004]
- Programa Operacional Regional de Lisboa 2020 [N.007317]
- Fundação para a Ciência e a Tecnologia [IF/00048/2014/CP1214/CT0010, PTDC/QEQ-PRS/0286/2014] Funding Source: FCT
Monoclonal antibodies currently dominate the biopharmaceutical market with growing sales having reached 80 billion USD in 2016. As most top-selling mAbs are approaching the end of their patent life, biopharmaceutical companies compete fiercely in the biosimilars market. These two factors present a strong motivation for alternative process strategies and process optimization. In this work a novel purification strategy for monoclonal antibodies comprising phenylboronic acid multimodal chromatography for capture followed by polishing by ion-exchange monolithic chromatography and packed bed hydrophobic interaction chromatography is presented and compared to the traditional protein-A-based process. Although the capital investment is similar for both processes, the operation cost is 20% lower for the novel strategy. This study shows that the new process is worthwhile investing in and could present a viable alternative to the platform process used by most industrial players.
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