Transforming Downstream Processing through Multi-Column Chromatography
- Posted by kmihlbachler
- On March 6, 2017
The call for implementing continuous processing in the manufacturing of bio-pharmaceuticals requires re-thinking of process chromatography and its equipment design. Proof-of-concepts of innovative multi-column continuous processes were introduced by the industry, which verified improvements in resin utilization and increased productivity [1]. Now, these concepts are transferred and verified at the pilot and production scale. First results are available.
Questions remain on how to scale up the standard chromatographic batch processes to continuous production scale, although significant progress has been achieved by also answering the technical and regulatory questions. We are now at the point where continuously operating technology is becoming part of the downstream processing (DSP) manufacturing platform. My upcoming presentation on March 16 will focus on multi-column technology and provide background information about the technology, its optimization and performance verification.
Additionally, my presentation will show how reducing the complexity in process and system design can improve process robustness and constancy. The requirements for the equipment design, process automation and regulatory aspects due to the implementation of continuous processing will be highlighted. Lastly, I will describe how current developments, such as process automation [2] to control variability in feed concentrations, and future trends in multi-column technology enable the integrated continuous downstream processing.
[2] http://www.sciencedirect.com/science/article/pii/S0021967313005529