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)
COLUMBUS, Ohio--(BUSINESS WIRE)-- Battelle, Andelyn Biosciences, Inc., and AmplifyBio, have been awarded a new task order from the National Institute of Neurological Disorders and Stroke (NINDS) to manufacture suspension process gene therapy for the transformative treatment of Aspartylglucosaminuria (AGU).
Battelle is the world’s largest independent nonprofit research and development organization; Andelyn Biosciences, Inc. is a pioneering and patient focused cell and gene therapy Contract Development and Manufacturing Organization (CDMO), and AmplifyBio is a drug development and commercialization partner for advanced therapies.
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.
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