MODIFICATION
B -- RECOVERY - Special studies and analysis—not R&D
- Notice Date
- 8/27/2010
- Notice Type
- Modification/Amendment
- NAICS
- 325414
— Biological Product (except Diagnostic) Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy & Infectious Diseases/AMOB, 10401 Fernwood Drive, Suite 2NE70, MSC 4811, Bethesda, Maryland, 20817
- ZIP Code
- 20817
- Solicitation Number
- RFQNIAID10172
- Archive Date
- 9/15/2010
- Point of Contact
- Reyes Rodriguez, Phone: 301-402-6074, Linda C Taylor, Phone: 301-402-5762
- E-Mail Address
-
rodriguezra@niaid.nih.gov, ltaylor@niaid.nih.gov
(rodriguezra@niaid.nih.gov, ltaylor@niaid.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Amendment to respond questions provided. 1) What is meant by 2 plasmid production? Is this multiple lots with the same plasmid, or is two unique plasmids? Answer - It is 2 unique plasmids - both are pCAGGS expression plasmid, but 1 encodes for the Matrix protein and the other for HA to make the VLP. 2) What is the final material expectation from the 5L batch? Answer - The total volume or quantity of material is not important to us, it is the final purified quantity of VLP that must be at least 5 mg, so your efficiency will determine this initial quantity before purification. 3) What are the specifications for purity and identity and yield? Answer - Purified Virus Like Protocol, at least 5 mg total 4) What virus strain is being produced? Need to know for assay determination. Answer - No virus strain is being produced. NIH is making virus like particles that are non-infectious because they have only the matrix protein and the HA protein (no genomic RNA, no replication, etc.). The matrix protein comes from a seasonal H1N1 called New York/312 and the HA proteins will come from TBD. 5) Will a reference standard be provided? Answer - There is no reference standard. The VLP will be verified by Western Blot using a anti-HA antibody that NIH can provide. 6) Are the production lots to be produced under GMP conditions? If not, what type of release document will be required (i.e. CoT, CoA)? Answer - Not GMP 7) Will the process protocols be provided, or will the vendor be expected to use generic protocols? Answer - The protocols should be the ones used by a company that specializes in preparation of Virus Like Protocols, so they should have in house protocols that optimize VLP production. The only requirement is that human cells are used, as different species glycosylate HA differently (e.g. no insect cells, etc.) 8) Is this a secreted process? Answer - No 9) Are the cells serum free? In suspension or adherent? Answer - No. Suspension or adherent depends on the protocol that the company that specializes in Virus Like Protocol production should have to grow VLPs or produce high quantities of plasmid (depending on which part of the process).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/AMOB/RFQNIAID10172/listing.html)
- Place of Performance
- Address: National Institutes of Health, NIAID, 9000 Rockville Pike, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN02258806-W 20100829/100828000101-ccb79cac027ce21d5f503b2ec68b1090 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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