The specialty measurement company says it is partnering with that institution 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 in the US.
Waters’ staff and university researchers will co-locate at Immerse Delaware, an Innovation and Research Lab, located at the Science, Technology and Advanced Research Campus of the University of Delaware, also home to the NIIMBL.
The company, students and faculty will look to identify and address the most significant challenges facing the biopharmaceutical industry.
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, argues Waters.
The company said the objective of the new partnership is to develop tools that would allow researchers to be able to better characterize bioprocesses, accelerate and enhance biologic selections and improve process control to ultimately improve product quality, yield, and process efficiency.
Steve Martin VP of research, Waters, told BioPharma-Reporter that this investment is essential for transformation in the bioprocessing sector:
“The bioprocess industry is siloed with internal development focusing on the release of specific medicine but benefits to improve processes aren’t realized on a larger scale.
“Significant advances require diverse teams including basic research, applied incubation programs and instrument companies to take-on the ambitious goal of advancing the entire sector and not just a single medicine.
“The proximity of the groups involved in these activities will undoubtedly accelerate progress which is why it was important for Waters to be physically located at the University of Delaware and close to NIIMBL.”
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.
In addition to investing in Immerse Delaware, Waters flagged that it is joining NIIMBL. That organization is key, it added, as it wants to accelerate biopharmaceutical innovation, support the development of standards that enable more efficient and rapid manufacturing capabilities, and educate and train a world-leading biopharma manufacturing workforce to advance US competitiveness in this field.
Martin said: “We are looking forward to engaging with this community. We recognize the central role that NIIMBL plays in bioprocess. This public/private partnership already has deep connections with regulatory bodies, well-established leaders and emerging players and technologies in the field of bioprocess. We are excited to listen, learn and apply in this environment.”