NEURESTA DRUG SUBSTANCE MANUFACTURING
Full Description
The overall objective of this SOW is for Leidos to support development of NgR(310)Fc [AXER-204] for treatment of spinal cord injury and produce quantities of hNgR(310)-Fc for use in human clinical studies, in technical and project management, records management, evaluation of quality systems, logistics and chemistry, manufacturing, and controls (CMC) development. An appropriate number of vials of Master Cell Bank (MCB) were provided to Leidos’ subcontractor to execute the work and manufacture the hNgR(310)Fc. The existing subcontractor (Cytovance Biologics) has completed process development and analytical development work, qualified relevant analytical assays, manufactured engineering lots on 100- L and 500-L scale and two GMP lots on 500-L scale under previous Leidos subcontract.
Grant Number: 75N91019D00024-P00010-759101900140-1
NIH Institute/Center: NIH
Principal Investigator: lynn briscoe
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