Press release -

Next Generation Technology for Continuous Processing: Interview with GE's Maria Ekblom

In the build up to Informa’s annual BioProduction meeting we take a deeper look at one of the key themes to this year’s agenda Continuous Manufacturing. We turn to GE Healthcare’s Senior R&D Project Manager Maria Ekblom for her thoughts on the subject.

Informa: What are the benefits of implementing continuous biomanufacturing?

     

ME: The move to continuous processing enables several advantages compared with batch operations. In the beginning, the main driver was that stability issues for specific proteins and enzymes could be reduced and product quality improved.Overtime, additional advantages have been seen. In a continuous process, equipment footprint can be reduced and facilities can be smaller. Another advantage is that also buffer volumes can be reduced. Development studies can be performed at commercial scale. With an integrated process, processing times can be reduced to eliminate the need of holdup tanks. As continuous processing becomes an established technology, validation efforts will also be reduced.

Informa: How can continuous chromatography enable productivity improvement?

     

ME: In batch chromatography, safety factors are required to prevent product loss in the flowthrough. By moving to continuous chromatography, and specifically to periodic counter-current chromatography (PCC), continuous loading is enabled by the use of two columns in the loading zone. In parallel, one or two additional columns can be subjected to wash, elution, and regeneration while waiting for being transferred to the loading zone. With this setup, the chromatography medium capacity utilization will be maximized, which gives an opportunity to improve productivity. We have seen examples of up to a three-fold increase in productivity; however, this will be dependent of your process.

Informa: What is the best way to structure continuous DSP and identifying which steps are feasible for continuous downstream processing?

     

ME: The driver for changing to continuous processing is based on the possibility to increase productivity, while minimizing holdup times. It is also a matter of evaluating your existing manufacturing platform and your facility setup to identify the bottlenecks in your current batch process. For MAb processing, we see a large interest in investigating PCC as a technology for improving productivity in the capture step.We also see an increasing interest in connecting the capture step to viral inactivation and polishing steps. For integrating process steps, connected processing or straight-through processing can be a solution.

Informa: What control processes and supporting technologies are necessary for the validation and analysis of continuous chromatography?

     

ME: Continuous chromatography gives a different scenario compared to batch process performed in a single run. As soon as steady-state is reached in continuous chromatography, a repeated sequence of steps will occur, and this will require tracking of any deviations over time. To meet this requirement, we have developed PAT tools for ÄKTA™ pcc to enable dynamic control to adjust for variations and introduce trend curves to monitor deviations. As continuous processing reaches manufacturing stage, validation strategies will need to be implemented. An expanded set of analysis tools will most likely be required for the full implementation. It is important to remember that FDA is supporting the implementation of continuous processing.

Informa: How do you see continuous chromatography advancing in the future?

     

ME: Continuous chromatography has a big potential. We see an overall trend of process intensification. Continuous processing offers a way to achieve higher productivity at shorter process time, while reducing total cost. Many in the industry expect these developments, but some are waiting for other to adopt and succeed with these technologies before they decide to follow. Therefore, the change to continuous processing will probably be gradual over the next decade or two.

We will continue to discuss the subject at the annual BioProduction meeting which will be taking place at the City West Hotel in Dublin, Ireland between the 14th & 15th October 2015. For further details about the conference or to review the program please visit:

http://www.informa-ls.com/event/BioProduction2015

Topics

  • Health, Health Care, Pharmaceuticals

Please contact daniel.barry@informa.com for further info

Tel: +44 (0) 207 017 6978

Contacts

Daniel Barry

Press contact Dr BPI Europe Project Manager