Partnership with Waters Corporation to focus on biopharma manufacturing needs

The University of Delaware is a growing powerhouse in research, education and workforce development focusing on biopharmaceuticals. These complex medicines produced from living cells — from insulin to COVID-19 vaccines — are highly effective in targeting diseases, but they also are extremely challenging to make.

UD and Waters Corporation, a pioneer in scientific measurement, have announced a five-year research partnership to advance analytical solutions in biopharmaceutical manufacturing. The company, headquartered in Milford, Massachusetts, has operations in 35 countries and more than 7,400 employees worldwide.

Through the partnership, Waters will sponsor Immerse Delaware, an innovation and research lab, to be established in early 2022 at the Ammon Pinizzotto Biopharmaceutical Innovation Center on UD’s Science, Technology and Advanced Research (STAR) Campus.

“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 Dennis Assanis, president of the 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.”

Waters Corporation scientists will partner with UD students and faculty in the Immerse Delaware lab to identify and address some of the most significant challenges facing the biopharmaceutical industry. The success of biotherapeutics such as monoclonal antibodies, cell and gene therapies and vaccines has transformed the life sciences industry. However, the optimization of the manufacturing process of these complex molecules 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 UD 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 among industry, academia and regulators.

“We strongly believe that the most difficult challenges can only be solved through collaboration across academia and industry. The Immerse Delaware lab follows from our highly successful launch of Immerse Cambridge, a Waters innovation and research lab,” said 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.”

Levi Thompson, dean of UD’s College of Engineering, and faculty in the College of Engineering collaborated with Batra to develop the partnership. Batra received his bachelor’s degree in chemical engineering from UD in 1991.

“It’s been wonderful working with Udit Batra, one of our college’s most accomplished alumni, to develop this exciting research partnership with Waters Corporation,” Thompson said. “This collaboration will not only drive solutions to major industry challenges, it will allow us to bring additional real-world issues into the classroom and advance business development in the region.”

Earlier this year, UD launched a new master’s degree program in biopharmaceutical sciences with industry support. In addition to traditional class and laboratory work, the program includes a 15-month internship with industry partners.

Immerse Delaware will be the second innovation hub of its kind that Waters is investing in creating, after Immerse Cambridge, which opened in September 2020 in Cambridge, Massachusetts. The new Delaware lab will feature a purpose-built research test bed, with a focus on leveraging liquid chromatography, mass spectrometry and adjacent technologies to support bioprocess engineers’ empirical data in the areas of process and informatics. Through these analytical solutions and data- and process-based approach, researchers will be able to better characterize bioprocesses, accelerate and enhance biologic selections and improve process control to ultimately improve product quality, yield and process efficiency.

Initial projects at Immerse Delaware will focus on gaining a deeper understanding of novel methods for quantifying and ultimately minimizing 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.

In addition to investing in Immerse Delaware, Waters has furthered its commitment to biopharmaceutical innovation by joining the National Institute for Innovation in Manufacturing Biopharmaceuticals. Located on UD’s STAR Campus, NIIMBL is a public-private partnership with the 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.

About Waters Corporation

Waters Corporation, 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.

Article by Tracey Bryant | Photo by Evan Krape | October 20, 2021