Solicitation

cGMP Drug Product Fill Finish Vialing of Axer-204

Person of Contact Shaneeka Owens (shaneeka.owens-bearden@nih.gov)
Proposal Due Date Monday, September 26, 2022 (Closed 2 months ago)
NAICS Codes 541714, 541715
  • Research Category Research & Development Services & Subcontracts
  • Solicitation Number S22-117
  • NCI OA Contract Number 75N91019D00024 – NCI-FFRDC

Description

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.

Proposal Instructions

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 shaneeka.owens-bearden@nih.gov.

Modified By Date Modified Sort ascending Comment
Shaneeka Owens

S22-117 Solicitation Amendment #1 issued to extend the offer due date to 2:00pm (ET) on Monday, September 26, 2022