SOLICITATION NOTICE
A -- GLP Safety Testing of Anti-viral Monoclonal Antibodies Developed by Vaccine Research Center (VRC), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) and Manufactured for Clinical Trial Use - RFP S11-215
- Notice Date
- 6/7/2011
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Science Applications International Corporation (SAIC), 92 Thomas Johnson Drive, Suite 250, Frederick, Maryland, 21702
- ZIP Code
- 21702
- Solicitation Number
- S11-215
- Archive Date
- 8/15/2011
- Point of Contact
- Jessica L. Reed, Phone: 3012284021
- E-Mail Address
-
reedjl@mail.nih.gov
(reedjl@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Sample Agreement Document for RFP S11-215 The mission of the Vaccine Research Center (VRC) is to facilitate the development and testing of new vaccine strategies, with primary focus on prevention of Human Immunodeficiency Viruses (HIV-1). Investigators at the VRC are working to develop a number of different vaccine product candidates and have discovered broadly cross-reactive monoclonal antibodies that neutralize ~90% of HIV-1 strains and clades. The target of the lead human monoclonal antibody is the CD4 binding site on the gp120 envelope protein of HIV. The materials to be tested for this requirement are investigational anti-viral human monoclonal antibodies. The mission of the Vaccine Research Center (VRC) is to facilitate the development and testing of new vaccine strategies, with primary focus on prevention of Human Immunodeficiency Viruses (HIV-1). Investigators at the VRC are working to develop a number of different vaccine product candidates and have discovered broadly cross-reactive monoclonal antibodies that neutralize ~90% of HIV-1 strains and clades. The target of the lead human monoclonal antibody is the CD4 binding site on the gp120 envelope protein of HIV. The materials to be tested for this requirement are investigational anti-viral human monoclonal antibodies. The Contractor shall perform Food and Drug Administration (FDA) mandated safety testing and characterization of clinical grade investigational anti-viral human monoclonal antibodies. The safety tests in animals must be conducted in accordance with Good Laboratory Practices (GLP) standards (21CFR, Part 58). The studies should be performed consistent with guidance in International Conference on Harmonization (ICH) M3(R2), S6, S6(R1), and S7A documents and other relevant guidance from FDA and ICH.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/contractor/S11-215/listing.html)
- Record
- SN02466540-W 20110609/110607235336-4374cadcd0794466c742207e48ce99fc (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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