MANUFACTURING OF PLASMID AND VECTOR AND GLP DOSE-ESCALATION TOXICOLOGY STUDIES

NIH RePORTER · NIH · N01 · $131,706 · view on reporter.nih.gov ↗

Abstract

Currently, the National Institute of Neurological Disorders and Stroke (NINDS), via its URGenT network, is funding a cooperative agreement for the manufacturing of an AAV9 vector, plasmids, and GLP dose-escalating studies as a potential therapy the severe and progressive genetic neurological disorder, Aspartylglucosaminuria (AGU). The goals of the URGenT cooperative agreement are to manufacture the vector, plasmid, and initial GMP batch. Specifics of the process will come during the tech transfer described in the base task. The final product qualification and characterization testing will include assays of sterility, endotoxin, purity, identity, activity/potency, vector genome titer, capsid particle titer, appearance, and genomic structure. Upon establishment of the vectors, and optimal characterization, this project will progress to IND-enabling toxicology studies to support the IND.

Key facts

NIH application ID
11172202
Project number
75N95022D00021-P00001-759502300003-1
Recipient
BATTELLE CENTERS/PUB HLTH RES & EVALUATN
Principal Investigator
Amanda Burnaugh
Activity code
N01
Funding institute
NIH
Fiscal year
2024
Award amount
$131,706
Award type
Project period
2023-09-30 → 2026-09-29