Partnership will focus on developing analytical solutions to better characterize bioprocesses towards improved quality, yields and efficiency

News Summary:

• Waters and University of Delaware announce a multi-year collaboration to develop technology for analytical characterization of manufacturing processes for biologics and novel modalities.
• Waters’ staff and university researchers will co-locate at Immerse™ Delaware, an Innovation and Research Lab, a new state of the art lab located at the Science, Technology and Advanced Research Campus of University of Delaware, also home to the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL).
• Projects will address needs of biopharmaceutical industry to improve drug product quality, yields, process efficiency and process control using LC-MS and adjacent analytical technologies.

Waters Corporation (NYSE: WAT) and the University of Delaware today announced a five-year research partnership to develop new analytical solutions for bioprocessing and biomanufacturing. Key to this partnership is Immerse™ Delaware, an Innovation and Research Lab, (“Immerse Delaware”) set to open in early 2022 located at the University of Delaware Science, Technology and Advanced Research (STAR) campus. At Immerse Delaware, Waters will partner with students and faculty to identify and address the most significant challenges facing the biopharmaceutical industry.

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The success of biotherapeutics such as monoclonal antibodies (mAbs), cell and gene therapies and vaccines has transformed the life sciences industry. However, the optimization of the manufacturing process of these complex medicines has been limited by the lack of robust analytical methods that clearly decouple the critical quality attributes of the product from the process parameters. Waters is partnering with University of Delaware because of its leadership in chemical and biological manufacturing research as well its active support and close proximity to the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), a collaborative effort amongst industry, academia, and regulators.

“We strongly believe that the most difficult challenges can only be solved through collaboration across academia and industry. Immerse Delaware follows from our highly successful launch of Immerse Cambridge, A Waters Innovation and Research Lab,” said Dr. Udit Batra, CEO and President of Waters Corporation. “Through this collaboration, researchers from both Waters and University of Delaware will identify and develop solutions that can better characterize biological manufacturing processes and drive improvements in quality, yields, efficiency and process control. Our partnership eventually aspires to decouple the product from the process, which can significantly accelerate the delivery of higher quality medicines to patients.”

"We are thrilled that an industry-leading innovator like Waters Corporation and the University of Delaware are forming this collaborative partnership to advance novel solutions to biopharmaceutical process development and manufacturing,” said Dr. Dennis Assanis, President, University of Delaware. “This is a true testimony to UD’s recognition as a national hub for innovation and talent development that feeds cutting edge progress across industries — including engineering, biopharmaceuticals, life sciences, and so much more. The Waters-UD groundbreaking initiative will help accelerate development of life-saving medicines, while simultaneously developing the workforce of the future.”

The Immerse Delaware Lab will feature a purpose-built research test bed, with a focus on leveraging LC-MS and adjacent technologies to support bioprocess engineers’ empirical data in the areas of process and informatics. Initial projects at Immerse Delaware will seek to gain a deeper understanding of novel schemes to quantify and ultimately minimize process-related impurities from uncontrolled glycosylation, which negatively impacts drug efficacy. These will be paired with informatic solutions to predict the evolution of biotherapeutic products.

Through its strategy to invest in academic and external partnerships, Waters is fostering a global community of scientific collaborators and innovators. Immerse Delaware, and future Immerse laboratories, will enable Waters to tap into a new set of talent and drive diversity of thought in its mission to improve human health and well-being.

In addition to investing in Immerse Delaware, Waters has furthered its commitment to biopharmaceutical innovation by joining NIIMBL. Located at the University of Delaware STAR campus, NIIMBL is a public-private partnership pursuing its mission to accelerate biopharmaceutical innovation, support the development of standards that enable more efficient and rapid manufacturing capabilities, and educate and train a world-leading biopharmaceutical manufacturing workforce, to fundamentally advance U.S. competitiveness in this industry.

Additional Resources

• Learn more about Immerse, a Waters Innovation & Research Lab
• Learn more about the University of Delaware’s STAR Campus
• Connect with Waters via Twitter, Facebook and LinkedIn

About the University of Delaware (www.udel.edu)

The University of Delaware, located in Newark, Delaware, traces its beginnings to a small private academy established in 1743. Today, UD is a research-intensive, technologically advanced institution offering more than 150 academic majors across nine colleges, serving more than 23,000 undergraduate and graduate students. The University's distinguished faculty includes internationally renowned authors, scientists and artists. The Carnegie Foundation for the Advancement of Teaching has classified UD as having very high research activity—a designation accorded fewer than 3% of U.S. colleges and universities. The University’s Science, Technology and Advanced Research (STAR) Campus in Newark is a growing center for innovation, blending cutting-edge research, top-notch academics and thriving businesses in one location. Delaware has 21 varsity sports teams that compete at the Division 1 level in the Colonial Athletic Association and the Football Championship Subdivision.

About Waters Corporation (www.waters.com)

Waters Corporation (NYSE: WAT), Waters Corporation (NYSE: WAT), the world's leading specialty measurement company, has pioneered chromatography, mass spectrometry, and thermal analysis innovations serving the life, materials, food and environmental sciences for more than 60 years. With more than 7,400 employees worldwide, Waters operates directly in 35 countries, including 14 manufacturing facilities, and with products available in more than 100 countries.

Waters and Immerse are trademarks of Waters Corporation.

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