– Waters and Sartorius expand collaboration to offer complete bioassays for downstream biologics manufacturing

Summary:

MILFORD, Mass. and GOETTINGEN, Germany, June 5, 2023 /PRNewswire/ — Waters Corporation (NYSE: WAT) and Sartorius announced a new collaboration to develop integrated analytical solutions for downstream biomanufacturing, expanding their joint agreement that began with the previous bioprocessing analysis. Software and hardware integrations between the Waters™ PATROL™ Ultra Performance Liquid Chromatography (UPLC™) process.

The Sartorius™ Analysis System and Resolute® BioSMB™ multi-column chromatography platform will provide bioprocess engineers with access to more comprehensive analytical data for downstream batch and continuous manufacturing, improving yields while reducing waste and lowering costs. biomanufacturing costs.

“Since the beginning of our collaboration with Sartorius, we have strived to offer bioprocess engineers faster and more direct access to critical information on the quality attributes of their pharmaceutical products, in order to improve production performance. and getting medicines to patients sooner,” said Jon Pratt, senior vice president of the Waters Division. Based on positive customer response to our collaborative efforts with bottom-up bioprocessing analytics, we see tremendous benefit in combining the PATROL process analytics system and Sartorius BioSMB to bring timely analytics from the decision point to the Downstream Biomanufacturing of Monoclonal Antibodies, Recombinant Proteins, Vaccines, and AAV Gene Therapies”.

“Now that intensive and continuous manufacturing of biologics is becoming a reality, there is a greater need for real-time analytical measurements,” explained René Fáber, Director of Sartorius’ Bioprocess Solutions Division. “The value of the combination of Sartorius and Waters technologies lies in the critical importance of analytics at the point of need, providing bioprocess engineers with a more complete understanding of their manufacturing process and its effects on pharmaceutical product quality. We believe this can have a significant impact on drug production costs by helping to increase yields and reduce waste.”

In-process sampling and analysis of biologics shipped to a central laboratory can take weeks before the necessary quality control results arrive. Waters and Sartorius have shown how bioprocess scientists can streamline these analyses, 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 the overall throughput of the process and on the quality of the product, since the individual operation of the downstream unit can be optimized much more easily, and corrective actions can be taken much faster.

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About Sartorius (www.Sartorius.com)

The Sartorius Group is one of the leading international partners in life sciences research and the biopharmaceutical industry. With innovative laboratory instruments and consumables, the Lab Products division

Acerca de Waters Corporation ( www.waters.com)

Waters Corporation (NYSE: WAT), a world leader in analytical instruments and software, has pioneered innovations in chromatography, mass spectrometry, and thermal analysis serving the life, materials, and food sciences for more than 60 years. With more than 8,200 employees worldwide, Waters operates directly in 35 countries, including 14 manufacturing plants, with products available in more than 100 countries.

Waters Contact:

Brian J. MurphyHead of Corporate PR and CommunicationsWaters Corporationbrian_j_murphy@waters.com 1 508-482-2614

Sartorius Contact:

Tim MeyerHead of Content OperationsSartoriusTimothy.meyer@sartorius.com 1 608-540-8269

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