Research & Development Services & Subcontracts
NCI OA Contract Number
75N91019D00024 – NCI-FFRDC
The overall objective of this Statement of Work (SOW) is for the Subcontractor to support the continued development of NgR(310)Fc [AXER-204] for treatment of spinal cord injury. The existing drug substance manufacturer 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 Biomed subcontracts. Currently the subcontracted drug substance CMO is manufacturing a third GMP batch (GMP3) of drug substance. The task for this SOW is for fill-finish of the GMP3 drug substance and release the drug product to support the ongoing clinical studies.
Solicitation Questions are due at 2:00pm (ET) on Wednesday, August 31, 2022. If interested in receiving the full Solicitation Package please contact the POC/Subcontracts Administrator Ms. Shaneeka Owens at firstname.lastname@example.org.