期刊
BIOTECHNOLOGY JOURNAL
卷 14, 期 2, 页码 -出版社
WILEY-V C H VERLAG GMBH
DOI: 10.1002/biot.201800061
关键词
COGm; future facility; integrated continuous bioprocessing; multicolumn chromatography; perfusion
The changing landscape of the biopharmaceutical market is driving a paradigm shift toward continuous manufacturing. To date, integrated continuous bioprocessing has not been realized as enabling technologies are nascent. In this work, a fully integrated continuous process is successfully demonstrated from pilot scale bioreactor to drug substance. Comparable product quality is observed between the continuous process and a 500 L fed-batch conventional process. The continuous process generated material at a rate of 1 kg of purified mAb every 4 days, achieving a 4.6-fold increase in productivity compared to the fed-batch process A plant throughput analysis using BioSolve software shows that a fed-batch facility with 4 x 12 500 L stainless steel bioreactors and purification train of the corresponding scale can be replaced by a continuous facility consisting of 5 x 2000 L single use bioreactors and smaller purification train, with a cost reduction of 15%.
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