60NANB23D138

Purpose: Provide equipment for NIIMBL gene vector production at the University of Delaware (UD). The equipment will facilitate process improvements, workforce development, and the testing and demonstration of biopharmaceutical innovations. This facility will leverage the knowledge and experience of the NIIMBL, a public-private partnership focused on the acceleration of the biopharmaceutical innovation.

Activities to be performed: This project will procure, install, and validate equipment at UD for gene vector production that will serve as a scale-down model of the industrial scale processes. Phase 1 will include finalizing details, specifications, and receive necessary quotations for equipment. In Phase 2, they will procure and install equipment, and perform site acceptance testing.

Expected outcomes: The UD gene vector production testbed will allow smaller scale, more rapid, and more affordable biopharmaceutical experiments to be performed. The testbed will enable workforce development and training, data to be collected and used in process models being developed, and produce new materials that can be shared with the biopharmaceutical manufacturing innovation community.

Intended beneficiaries:
1. To NIST: The work plans align with NIST's manufacturing mission space for both advanced manufacturing technology and supply chain security. NIST staff can leverage this project to further the impact of our technical expertise in biomanufacturing for gene therapies. The project also leverages NIST's investment in NIIMBL.
2. To awardee: The University of Delaware, as the lead of the NIIMBL consortium, will be able to establish a more cost-efficient capability to do small scale process-development work on industrially relevant equipment for gene therapy manufacturing innovation.
3. To the nation: The importance of an agile domestic capacity for production of biomanufactured gene therapies is critical for advancing the nation's capabilities to support both domestic competitiveness and public health needs. The University of Delaware's leadership of the NIIMBL partnership supports the collaborative development of the next generation processes for manufacturing these critical products. This funding will enable NIIMBL to provide an open collaboration resource for the US bioeconomy that will aid in developing new technologies to support faster to market, higher quality, and extended supply and availability of cellular and gene-therapy products.

Subrecipient activities: No subrecipient activities will be involved with this grant.

University Of Delaware

11.617 - Congressionally-Identified Projects

National Institute of Standards and Technology (NIST) [DOC]

Newark, Delaware 19716-0099 United States

Single Zip Code

None

Amendment Since initial award the End Date has been extended from 10/31/24 to 10/31/26.