Ultrasound improves biopharma purification
significant improvements in productivity, lower costs and greater
drug purity, says study
The use of ultrasound technologies to monitor the process-scale column chromatography can lead to significant improvements in productivity, lower costs and greater drug purity, according to a study presented at the 16th Annual International Symposium on Preparative/Process Chromatography in San Francisco, USA.
The study was conducted on Euroflow (UK) Ltd's column chromatography systems, which were licensed on a worldwide basis to Pall Corp at the end of March. Euroflow's columns are designed to improve the efficiency, quality and consistency of downstream purification processing for biopharmaceuticals, including monoclonal antibodies, vaccines, plasma and peptides.
The 16-transducer ultrasound array tested in the study was also licensed from Euroflow and, according to the results, provides the first real-time control of chromatography packing and column integrity. Improperly packed columns can result in huge cost overruns due to time delays, process failures and additional handling of the media.
Using the ultrasound technology, process operator were able to monitor and control the rate at which a column bed is formed and compressed, so that packed bed irregularities can be identified early on in a manufacturing cycle, helping to ensure process consistency and optimum performance.
"There is an ideal packing rate profile by which a column bed builds to give optimum performance. Ultrasound enables the monitoring and hence automation of that process. It can also be used to detect fouling of the packed bed", said Martin Hofmann, Euroflow's scientific director, who presented the data.
Pall and Euroflow said they plan to commercialise the ultrasound technology for process chromatography applications later this year.