Acquisition of cGMP-grade GS-441524 for the Treatment of COVID-19
Closed Solicitation Posted
- Solicitation number
- 75N95021Q00015
- Agency
-
National Institute on Drug Abuse
National Institutes of Health, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 325412 Pharmaceutical Preparation Manufacturing
- PSC
- 6505 Drugs And Biologicals
Notice details come from SAM.gov. Updated .
About this opportunity
The National Center for Advancing Translational Sciences within the National Institutes of Health seeks to procure two kilograms of cGMP-grade GS-441524 drug substance from a qualified contract manufacturing organization, with an option for two additional kilograms. The purpose of this acquisition is to provide support for preclinical and Phase I clinical studies evaluating GS-441524's potential as a treatment for COVID-19 by gathering data on its safety, tolerability, efficacy, pharmacokinetics, and optimal dose range in humans. Quotations will be evaluated based on technical capability, delivery timeline, past performance, and price, and must be received by December 1, 2020 to be considered.
There is no set-aside designation for this requirement. The NAICS code is 325412 and PSC code is Q1FX. The place of performance will be the contractor's facility. Award is expected on December 7, 2020 in the form of a purchase order made to the vendor presenting the best value quotation without discussions. The total value is undetermined but will be less than $250,000 based on market prices for similar quantities of cGMP drug substance.
Notice text
The National Center for Advancing Translational Sciences (NCATS) is a part of the National Institutes of Health (NIH), with a mission to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions.
NCATS is evaluating GS-441524 as a potential treatment for SARS-CoV-2 infection. GS-441524 is the parent nucleoside of remdesivir and has similar efficacy to remdesivir in vitro. GS-441524 is a stable crystalline compound with good physical properties for formulation, and the 3-step synthesis of GS-441524 makes it suitable for large scale production.
The purpose of this acquisition is to provide Chemistry, Manufacturing and Controls (CMC) support for the preclinical and clinical development of GS-441524 as a potential antiviral against SARS-CoV-2, the causative agent of the pandemic disease COVID-19. NCATS will perform preclinical and Phase 1 clinical studies with GS-441524, and gather information on its safety and tolerability, efficacy, pharmacokinetics, and dose-range in human. To cover the requirements of the studies, NCATS will need a batch of GS-441524 adhering to current Good Manufacturing Practice (cGMP) guidelines from a qualified Contract Manufacturing Organization (CMO).
See attached Request for Quotations and associated attachments for complete requirement details.
Files
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