SOLICITATION NOTICE
99 -- Blood Product
- Notice Date
- 8/10/2005
- 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
- NOI5094
- Response Due
- 8/25/2005
- Archive Date
- 9/9/2005
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are not being requested and a written solicitation will not be issued. The solicitation number is issued as a Notice Of Intent; NOI5094. This NOI is not a small business set aside. This solicitation and its incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 05-03. This acquisition will be processed under Simplified Acquisition Procedures. The associated North American Industry Classification System (NAICS) Code for this acquisition is 325414 and the small-business size is 500. SCHEDULE: The NIAID is soliciting quotations from offerors to acquire large scale production and purification of several selected humanized IgG antibodies against dengue and other flaviviruses, including West Nile virus and Japanese encephalitis virus. The objective is to use the purified IgG antibodies for functional characterization in vitro and in vivo for our on-going mouse and monkey protection studies. The contractor will perform the following to produce and purify several selected humanized IgG antibodies, using our own one-plasmid system for transient transfection of mammalian T293 cells. A total of seven IgG antibodies will be produced from their respective plasmid. We expected to obtain 10-50 mg of highly purified IgG antibody, each. Seven plasmid constructs are designated as follow: pIgG 1A5 ?dA; pIgG 1A5-dB; pIgG 3E4; pIgG 1A10; pIgG A3; pIgG MAB2; pIgG IIIE3. The contractor will use a 10-L culture of T293 cells for production and purification of each monoclonal antibody. The yield is expected to be in the range of 10-50 mg of IgG antibody each. The contractor will provide a written report of the data analysis. The contractor is required to keep all data confidential and to provide written reports and/or recommendations at the request of NIAID. The Laboratory of Infectious Diseases (LID), DIR, NIAID, with its extensive work in the area of vaccine development, including preclinical and clinical trials, has need for large scale production of purified IgG antibodies for functional characterization and analysis of protection against virus challenge in animals. Highly potent antibodies against provide an alternative for protection against infection. The LID is currently involved in the design and implementation of a number of trials of candidate vaccines against respiratory, gastroenteric, hepatitis and arthropod-borne viruses. In the absence of skilled statistical advice, inappropriate trial design or analysis could result in the emergence of incomplete data or of misleading conclusions. For example, the sample size could be too small to detect differences, or post hoc analysis could result in false conclusions. The selected contractor is proposed to provide NIAID with the proper quantities of IgG antibodies to be used in our on-going in vitro functional characterizations and animal protection studies. The contractor has been used in the past and has developed a protocol for cultivating suspension cell lines in scalable systems, suitable for this production. This company has a long history of expertise in IgG antibody production and purification, specific knowledge regarding the design, monitoring of products, conduct and production of such a bioreactor. The contractor has produced 1A5 and 5H2 IgG antibodies for our lab in the past with excellent results. Therefore, they have the specific knowledge of our products and how they need to be handled to optimize production and purification. Changing variables at this time would prevent correct interpretation of the experiment(s) in progress (FAR 6.302-1) Project No. AI 000682-15. The following Federal Acquisition Regulations (FAR) provisions and clauses apply to this acquisition: FAR 52.212-1 Instructions to Offerors-Commercial Items; FAR 52.212-2 Evaluation-Commercial Item; FAR 52.212-3 Offerors presentations 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 of Executive Orders?Commercial Items; and FAR 52.204-7 Central Contractor Registration (www.ccr.gov). The Government intends to select the offer that represents the best value to the Government, price and all other factors considered. In order to be considered for an award, offeror must have completed the online electronic Representatives 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. Offers must be submitted no later than 5:00 P.M. Eastern Daylight Time (EDT), August 25, 2005 to Ms. Roshawn Simpson. Copies of the aforementioned clauses are available upon request by telephone to Ms. Roshawn Simpson at (301) 594-3419. For delivery through the Postal Service, the address is NIH/NIAID/AMOB, 10401 Fernwood Drive, Room 2NE-70-A, MSC: 4811, Bethesda, MD 20892-4811. Electronic transmissions will not be accepted. Requests for information concerning this requirement are to be addressed to Ms. Roshawn Simpson at (301) 594-3419. Collect calls will not be accepted. All responsible sources may submit an offer that will be considered by this agency.
- Place of Performance
- Address: NIAID/NIH, Bethesda, MD
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN00867040-W 20050812/050810212017 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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