SOLICITATION NOTICE
99 -- Biological Product
- Notice Date
- 8/4/2005
- Notice Type
- Solicitation Notice
- 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, MD, 20817
- ZIP Code
- 20817
- Solicitation Number
- NOI5090
- Response Due
- 8/19/2005
- Archive Date
- 9/3/2005
- Small Business Set-Aside
- Total Small Business
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation number for this acquisition is NOI5090 and is being issued as a Notice of Intent. The incorporated provisions and clauses are those in effect through Federal Acquisition Circular 05-04. This acquisition will be processed under Simplified Acquisition Procedures (SAP) and is a small business concern. The associated North American Industry Classification System (NAICS) Code 325414, which has a business size standard of 500. The National Institute of allergy and Infectious Diseases (NIAID) intends to procure services from Tretragenetics the only known company that specialized in Tetrahymena expression system. The company holds the US patent of ?recombinant expression of heterologous nucleic acids in protozoa? (US6,846,481 B1). They have considerable success expressing similar GPI-anchor membrane proteins from other protozoan parasites (including Plasmodium) using this system. NIAID has developed malaria vaccine candidates that need to be tested for expression using an expression system that Tetragenetics owns a patent. The goal is to express biologically active, correctly folded recombinant proteins at high enough levels to carryout pre-clinical studies. Due to the complex structure of Pfs48 and Pfs230, the efforts to express these proteins in conventional systems such as E. coli or yeast have failed to produce proteins with native confirmation. Tetragentics is to advise on the (1) Consultation of gene design - optimal constructs for overexpression of P. falciuparum genes for Pfs48/45 and Pfs230. Selection of N- and C-terminal signal peptides; correct placement of fusion tags and restriction sites for cloning, qty-1, (2) Expression vector - material supplied: 20 ug pMTT1 T. thermophila expression vector containing a) Cd++-sensitive metallothionein promoter; b) downstream transcriptional processing sites from the Beta-tubulin 1 gene of T. thermophila; and, c) Hind III and BamH I restriction sites for insertion of foreign genes, qty-1, (3) DNA cloning - Plasmid DNA (pMTT1 containing relevant inserts) will be transformed into E. coli K-12 bacterial strains, amplified, subjected to large-scale purification, restriction endonuclease digestion and re-purification, qty-1, (4) Gold coating - gold microcarriers will be coated with DNA at optimal concentrations for transformation of T. thermophila strain CU522, qty-1, (5) Transformation and Section - microcarrier bombardment and selection of transformants: Coated microspheres will be introduced into T. thermophila strain CU522 using biolistric bombardment and positive trasformants selected by growth in the microtubule-stabilizing agent paclitaxcel. Transformation will be verified by PCR using appropriate primers. A minimum of 5 positive transformants (cell lines) for each gene construct will be produced and supplied to NIAID, qty-1, (6) Verification of protein expression - Recombinant T. thermophila cell lines be examined for protein expression by Western blotting analysis of cells and culture supernatants using protein-specific antibodies (supplied by NIH) or antibodies against the 6Xhis tag, followed by appropriate secondary antibody conjugates linked to HRP. Large numbers of shake flask will be used to screen for optimal expression. Tetragenetics will verify expression from each construct via western blot using protein specific antibodies (supplied by NIAID laboratory). The contractor shall: a) provide transformed cell lines and cloning vectors b) provide screening testing for expression within 12 weeks of receiving the test clone, c) provide all relevant data for the construction of cell lines, d) provide estimations of protein expression levels from each cell line submitted, e) provide the NIAID laboratory with at least five (5) transformed cell lines from each vaccine candidate 1) Pfs48/45 and 2) Pfs230, f) Provide advice on the proper growing conditions of the cell lines and induction of protein synthesis using the appropriate promote system, and e) experience personnel. The contractor shall supply all necessary material to perform the studies all relevant data for the construction of transformed cell lines along with estimates of protein expression levels to the NIH Malaria Vaccine Development Branch. In addition, Tetragenetics will provide NIH with a minimum of 5 transformed cell lines for each version of the Pfs48/45 and Pfs230 gene noted above for subsequent purification of protein. Consultation on optimal growth of cells and induction of protein synthesis using the cadmium-sensitive MTT1 promoter will be provided at no cost. The government will be furnishing gene constructs for each of the vaccine candidates to Tetragenetics. Antibodies against each vaccine candidate for the Western blot verification step. All work will be inspected by NIAID scientist personnel by in-house testing procedures. Place of delivery is NIH/NIAID, Rockville, Maryland 20852. The government will award a fixed price purchase order to the responsible contractor. The following FAR provisions and clauses apply to this acquisition: FAR 52.212-1 Instructions to Offerors Commercial Items; FAR 52.212.3 Offeror Representations and Certifications Commercial Items; FAR 52.212-4 Contractor Terms and Conditions Commercial Items; FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items. A completed copy of provisions at FAR 52.212-3 Offerors Representations and Certifications Commercial Items must be included. Copies of the aforementioned clauses are available upon request by telephone to Ms. Tonia Alexander at (301) 496-2607. Offerors must include with their offer a completed copy of the provisions at FAR 52.212-3, Offerors Representations and Certifications ? Commercial Items. Offers must be submitted no later than 5:00 PM Eastern Daylight Time (EDT) August 19, 2005 to Tonia Alexander. For delivery through the Postal Service, the address is NIH/NIAID/AMOB, 10401 Fernwood Drive, Suite 2NE62C/MSC 4812, Bethesda, Maryland 20817-4812. Electronic submission will not be accepted. In order to be considered for an award, offeror must have completed the online electronic Representations and Certifications located at http://orca.bpn.gov/ in accordance with FAR 4.1201(a). By submission of an offer, the offeror acknowledges the requirement that a prospective awardee shall be registered in the CCR at: www.ccr.gov/ prior to award, during performance, and through final payment of any contract, basic agreement, basic ordering agreement, or blanket purchasing agreement resulting from this solicitation.
- Place of Performance
- Address: Place of Delivery:, NIH/NIAID, Rockville, MD
- Zip Code: 20852
- Zip Code: 20852
- Record
- SN00862215-W 20050806/050804211851 (fbodaily.com)
- Source
-
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