Industry benefits from the use of state of the art approaches to process development and analytical technologies. Small companies often do not have the resources needed for specialized equipment and the process development testbed can help fulfill this need.
This project to outfit a Process Development Testbed to address the industry’s need for access to sophisticated biomanufacturing infrastructure. By providing shared access to upstream, downstream, and analytical systems, along with standardized workflows and training programs, the testbed will enable faster technology adoption and reduce process development timelines.
Impact on the development of the principal discipline(s) of the project. The acquisition of a complete range of process development equipment that is shared and made available in support of the NIIMBL mission positions NIIMBL, as well as individual members of the NIIMBL community, for a rapid response to coronavirus threats. Moreover, in the absence of a clearly identified coronavirus threat, this capability can be used to support the broader development of manufacturing approaches for biopharmaceuticals.
Impact on other disciplines. Beyond the research and development benefits of these capabilities, there are opportunities to leverage this capability to both a) support small businesses developing processes for their biopharmaceuticals and b) support workforce training on specific pieces of equipment.
Impact on the development of human resources: Access to the equipment will lead to training opportunities for undergraduate students, graduate students, and postdocs, as well as career scientists working across different disciplines that intersect with biopharmaceutical manufacturing.
Impact on teaching and educational experiences. Access to the equipment will lead to training opportunities for undergraduate students, graduate students, and postdocs, as well as career scientists working across different disciplines that intersect with biopharmaceutical manufacturing.
Impact on physical, institutional, and information resources that form infrastructure. This equipment provides physical capabilities that can be accessed, based on priority needs, by the NIIMBL community and the University of Delaware community.
By implementing a state-of-the-art Process Development Testbed at NIIMBL’s facility in Delaware, organizations, particularly small companies and academics, can access technologies that are commonly used by large companies and that are otherwise too expensive for them to access. Data from such technologies can help accelerate timelines for scale-up of biopharmaceutical manufacturing. Such a testbed can also support technology benchmarking across the industry.
Installation and commissioning of upstream, downstream, and analytical equipment for bioprocess development.
Leibiger, T., Min, L., & Lee, K.H., (2025). A comparison of SWATH-MS methods for measurement of residual host cell proteins in adeno-associated virus preparations. Frontiers in Bioengineering and Biotechnology, https://doi.org/10.3389/fbioe.2025.1579098
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