Instrument and software manufacturers Waters and Sartorius decided to collaborate to offer integrated process analytics for chromatography columns. The collaboration expands the companies’ existing partnership from upstream to cover downstream analytics.
The aim is to provide integration between Sartorius’ Resolute® BioSMB™ multi-column chromatography system and Waters’ PATROL™ UltraPerformance Liquid Chromatography (UPLC™) Process Analysis system.
“Through this collaboration, we should be able to make downstream biomonitoring more cost effective and reduce the amount of chromatography resins being used,” says Geert Lissens, PhD, head of product management for separation systems at Sartorius. “And it’s also about operational excellence for our customers because they can take decisions more quickly on the manufacturing floor.”
According to Lissens, a major application for Sartorius is in monoclonal antibody (mAb) manufacturing where companies need to decide how many chromatography columns to use. While today it can take two to three weeks to analyze data on, for example, aggregation and charge variance, Lissens notes that integrating the systems can reduce timescales to a matter of hours.
The result is that companies can know their purification is good enough to not need an extra column, explains Davy Petit, senior director and portfolio owner for biologics at Waters. This, in turn, reduces resin consumption and, according to Lissens, could potentially improve the efficiency of cleanroom use and enable faster safe batch release to market.
Currently, points out Petit, the PATROL UPLC offers at-line process analytics and the systems need to be purchased separately. The companies hope to fully integrate their systems as their partnership develops.
“The big benefit is where the end user operates in the future out of one solution,” continues Petit. “What’s unique is the integration of capable instruments on the analytical and production side to give the best of both worlds.”