SOLICITATION NOTICE
Q -- Characterization of 2 lots of DON (non-cGMP), Characterization of 2 lots of DON and Analytical Method Validation
- Notice Date
- 2/26/2020 12:32:41 PM
- Notice Type
- Presolicitation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH NIAID BETHESDA MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- NOI-NIAID-2011010
- Response Due
- 3/6/2020 12:00:00 PM
- Archive Date
- 03/21/2020
- Point of Contact
- Skye Duffner, Phone: 4068026092, Laura Grey, Phone: 4063759812
- E-Mail Address
-
skye.duffner@nih.gov, laura.grey@nih.gov
(skye.duffner@nih.gov, laura.grey@nih.gov)
- Description
- This is a Notice of Intent, not a request for proposal.� The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) intends to negotiate on an other than full and open competition basis with MRIGlobal, Kansas City, MO 64110 for Characterization of 2 lots of DON (non-cGMP), Characterization of 2 lots of DON and �Analytical Method Validation. The Lymphocyte Activation Section of the� Laboratory of Immunogenetics (LIG) conducts research on the molecular mechanisms underlying the activation of B lymphocytes to proliferate and differentiate into clones of antibody producing cells. DON (6-diazo-5-oxo-L-norleucine) is a glutamine antagonist, evaluated previously in several Phase I and II clinical trials as an anti-cancer agent. Toxicity was rare, but findings of minimal anti-tumor efficacy curtailed further evaluation for this indication. Through a rational drug discovery process, we identified DON as a candidate adjunctive therapy for Cerebral Malaria (CM). The National Cancer Institute (NCI) has previously synthesized DON and conducted clinical trials in 500 human patients both pediatric and adult. The National Cancer Institute (NCI) has previously synthesized DON and conducted clinical trials in 500 human patients both pediatric and adult. They still have a batch of that API that they have transferred to us. The overall objective of this project is to validate an analytical method for use in the cGMP characterization of the 2 lots of 6-diazo-5-oxo-L-norleucine (DON). MRIGlobal has analyzed this material in the past (c.a., 1998), however the method was not validated at the time. Therefore, the method will require analytical validation in order to generate a cGMP certificate of analysis. In addition to method validation, a full characterization of the drug substance is needed to support the use of this material for drug product manufacturing and ultimate use in a human clinical trial. As such, several tests will be carried out to fully characterize the material. The statutory authority for this sole source requirement is 41 U.S.C.1901 (e) (2) as implemented by FAR 13.106-1 only one responsible source and no other supply of service will satisfy agency requirements. THIS IS NOT A REQUEST FOR PROPOSAL.� All responsible sources that could provide comparable services may submit a capability statement that will be considered by email (subject line to reference NOI-NIAID-2011010) to Skye Duffner at skye.duffner@nih.gov, by 3:00 pm eastern standard time, March 06, 2020.� All responses received by the closing date of this synopsis will be considered by the Government.� A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government.
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/318d58779fe14bd0b4789c1ff7990a2d/view)
- Place of Performance
- Address: Rockville, MD 20852, USA
- Zip Code: 20852
- Country: USA
- Zip Code: 20852
- Record
- SN05572948-F 20200228/200226230255 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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