Battelle, Andelyn Biosciences, and AmplifyBio Awarded Task Orders for Plasmid and Suspension AAV Vector Manufacturing and IND-enabling Studies from the National Institute of Neurological Disorders and Stroke (NINDS)
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Monday, November 20, 2023
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NINDS, via its Ultra-rare Gene-based Therapy (URGenT) network, is funding a cooperative agreement for the manufacturing of plasmids and AAV gene therapy, and GLP preclinical studies, for AGU which is a severe and progressive genetic neurological disorder.
Key Points:
- NINDS, via its Ultra-rare Gene-based Therapy (URGenT) network, is funding a cooperative agreement for the manufacturing of plasmids and AAV gene therapy, and GLP preclinical studies, for AGU which is a severe and progressive genetic neurological disorder.
- Andelyn will manufacture the gene of interest plasmid, packaging/helper plasmids, and AAV vector, while AmplifyBio will perform IND-enabling GLP preclinical studies and Battelle will provide assay support for the ELISA and enzyme activity portions of the studies.
- The task orders follow the announcement made earlier this year of the team of Battelle, AmplifyBio and Andelyn Biosciences winning a seat on an eight-year, $149 million indefinite delivery, indefinite quantity (IDIQ) contract vehicle from NINDS.
- The ACC augments Andelyn’s two other Columbus facilities offering pre-clinical process development and plasmid manufacturing.