Waters Corporation and Sartorius entered into a collaboration to develop integrated analytical solutions for downstream biomanufacturing, expanding their joint agreement that began with upstream bioprocessing analytics. The alliance integrates software and hardware between the Waters PATROL UltraPerformance Liquid Chromatography (UPLC) Process.

The analysis system and the Sartorius Resolute BioSMB multi-column chromatography platform provides bioprocess engineers access to more comprehensive analytical data for downstream batch and continuous manufacturing, improving yields while reducing waste and driving down biomanufacturing costs.

“From the beginning of our collaboration with Sartorius, we’ve strived to give bioprocess engineers faster and more direct access to critical quality attribute information about their drug products in the name of improving production yields and getting drugs to patients faster,” said Jon Pratt, senior vice president, Waters Division. “Based on the positive response of customers to our collaborative efforts with upstream bioprocessing analytics, we see tremendous benefit to combining the PATROL Process Analysis System and the Sartorius BioSMB to bring timely point-of-decision analytics to downstream biomanufacturing for monoclonal antibodies, recombinant proteins, vaccines and AAV gene therapies.”

“Now that intensified, continuous manufacturing of biologics is becoming a reality, there is a greater need for real-time analytical measurement,” said René Fáber, head of bioprocess solutions division, Sartorius. “The value of combining technologies from Sartorius and Waters lies in bringing fundamentally important analytics to the point where it is needed and giving bioprocess engineers a more complete understanding of their downstream manufacturing processing and its effects on drug product quality. We believe this can have significant impacts on drug production costs by helping to increase yields and reduce waste.”

According to the company, in-process sampling and the analysis of biological drugs sent to a central laboratory can take weeks before the results of necessary quality checks are in. Waters and Sartorius have shown how bioprocess scientists can streamline these analytics, so that product quality tests for protein A, aggregation and charge variants occur closer to the process, potentially saving weeks of production time. This has a positive impact on total process yield and product quality because the individual downstream unit operation can be further optimized much more easily, and corrective actions can be taken much faster.