Waters and Sartorius Expand Collaboration to Offer Comprehensive Bioanalysis for Downstream Biologics Manufacturing

Monday, June 05, 2023

Waters Corporation (NYSE: WAT ) and Sartorius announced a new collaboration to develop integrated analytical solutions for downstream biological manufacturing, expanding their  joint agreement  started with the analysis of upstream bioprocesses. Software and hardware integrations between the  PATROL™ UltraPerformance Liquid Chromatography process analysis system

(UPLC™)  from Waters™ and  Sartorius™ Resolute ®  BioSMB™ Multi-Column Chromatography Platform  will enable bioprocess engineers to access more comprehensive analytical data for downstream batch and continuous manufacturing, improving yields while reducing the waste and costs of organic manufacturing.

"Since the beginning of our collaboration with Sartorius, we have strived to offer bioprocess engineers faster and more direct access to essential information on the quality elements of their pharmaceutical products, in order to improve production yields and medications to patients more quickly,” says Jon Pratt, senior vice president of Waters Division. “Given the positive customer response to our collaborative efforts in the area of ​​upstream bioprocess analysis, we believe there is tremendous benefit in combining the PATROL process analysis system and the Sartorius BioSMB system. to provide timely, decision-point analyzes for the downstream biomanufacturing of monoclonal antibodies, recombinant proteins, vaccines, and AAV gene therapies.”

“Now that the intensive and continuous manufacturing of biologics is becoming a reality, there is an increasing need for real-time analytical measurements,” says René Fáber, Head of Sartorius' Bioprocess Solutions Division. “The combination of Sartorius and Waters technologies has the advantage of providing fundamental analyzes where they are needed and enabling bioprocess engineers to better understand downstream manufacturing processes and their effects on the quality of pharmaceutical products. We believe this approach can have a significant impact on drug production costs as it increases yields and reduces waste. »

In-process sampling and analysis of biologic drugs sent to a central laboratory can take weeks before the necessary quality control results are available. Waters and Sartorius have shown how bioprocess scientists can streamline these analyzes so that product quality testing for protein A, aggregation, and charge variants is done closer to the process, enabling save weeks on production time. This has a positive impact on the total yield of the process and on the quality of the product, because the operation of each downstream unit can be optimized much more easily and corrective measures can be taken much more quickly.

Additional Resources

Find out more about Sartorius' Resolute BioSMB system .
Learn more about the Waters PATROL UPLC process analysis system .
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About Sartorius  ( www.Sartorius.com )

The Sartorius Groupis a leading international partner of life science research and the biopharmaceutical industry. With innovative laboratory instruments and consumables, the Lab Products and Services division of the group strives to meet the needs of research and quality control laboratories of pharmaceutical and biopharmaceutical companies as well as university research institutes. The Bioprocess Solutions division, with its broad portfolio of products focused on single-use solutions, helps its customers to manufacture biopharmaceuticals and vaccines in a safe, rapid and cost-effective manner. The company, headquartered in Göttingen, Germany, enjoys a strong international presence with around 60 production and sales sites worldwide. Sartorius is showing significant organic growth and is steadily expanding its portfolio through the acquisition of complementary technologies. In fiscal year 2022, the company generated revenue of approximately EUR 4.2 billion. At the end of 2022, approximately 16,000 employees worked for customers around the world.

About Waters Corporation  ( www.waters.com )

Waters Corporation  (NYSE: WAT ), a global leader in analytical instruments and software, is a pioneer in innovations in chromatography, mass spectrometry and thermal analysis, serving the life sciences, materials and in the food industry for over 60 years. Waters, which employs more than 8,200 people worldwide and operates directly in more than 35 countries, has 14 manufacturing plants. Its products are available in more than 100 countries.

Waters, UPLC and PATROL are trademarks of Waters Corporation. Sartorius, Resolute and BioSMB are trademarks of Sartorius AG and/or its affiliates.

Contact chez Waters :

Brian J. Murphy
Public Relations Manager, Corporate Communications
Waters Corporation
brian_j_murphy@waters.com
+1 508-482-2614