SOLICITATION NOTICE
A -- Generation, Characterization and Production of Monoclonal Antibody VRC01 - Solicitation Package
- Notice Date
- 2/26/2010
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Bldg 427, Room 12, Frederick, Maryland, 21702
- ZIP Code
- 21702
- Solicitation Number
- S10-129
- Archive Date
- 3/30/2010
- Point of Contact
- Max R. Moore, Phone: 3012284019
- E-Mail Address
-
mooremax@mail.nih.gov
(mooremax@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- S10-129 Attachment 2 is the statement of work. S10-129 Attachment 1 is the sample subcontract agreement. RFP S10-129 includes the instructions to offerors and evaluation criteria. This contract will cover the generation and characterization of a stable CHO cell line expressing the VRC01 MAb and production of bulk materials for preclinical and clinical trial along with the required lot release and stability testing of all clinical materials. This contract will also include formulation development to obtain a drug product formulation that is suitable for the proposed clinical trials. Additionally, this contract includes QA and regulatory support for lot release and filing of all regulatory documents with the FDA for VRC sponsored INDs.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/FCRF/S10-129/listing.html)
- Record
- SN02077814-W 20100228/100226235528-ccf78aee55c35e501085660ee6161c91 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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