As the biopharmaceutical industry implements continuous processing we see a necessity for a scalable and productive chromatography approach. Here we demonstrate the Cadence BioSMB platform which enables processing of bioreactor volumes ranging from 20L to 200L using the Cadence BioSMB PD and up to 2000L with the Cadence BioSMB Process.<br/>At the 2000L scale we show that with minimal process development a Protein A process can be transformed from batch to continuous with a large increase in productivity and 80% reduction in the volume of resin required. At the 200L (1g/l titer) scale we have operated an integrated continuous chromatography process comprising of five steps: Protein A capture, viral inactivation, depth and sterile filtration, anion exchange, and mixed mode cation exchange. The capture step involves eight Protein A columns that are loaded continuously and sequentially. The system that performs the capture step is also employed to operate the low pH hold for viral inactivation. After the viral inactivation step turbidity is reduced using depth and sterile filtration. The polishing steps are operated on a single system. AEX is loaded in flow through mode directly onto two mixed mode cation exchanger columns operated in bind and elute mode. By operating these five processes in a continuous integrated manner we achieve up to a five-fold increase in productivity and can produce 150g of polished mAb in less than 20 hours. This continuous process reduces the resin volume required for processing by as much as 95% while achieving single digit parts per million of host cell proteins and 1% aggregate. Additionally, the continuous process consumes 44% less buffer than batch operation.<br/>

Demonstration of a highly productive and scalable continuous chromatography approach

253rd National Meeting (2017)

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.