99 -- BLOOD

National Institute of Health (NIH), National Institute of Allergies and Infectious Diseases (NIAID) intends to negotiate on a sole source basis, with Kemp Biotechnologies, Inc. for antibodies. This Notice of Intent is being issued under NOI6050. The statutory authority for this acquisition is FAR 13.501 and award is anticipated to be made under a Firm Fix Price Order. The acquisition documents and incorporated provisions and classes are those in Federal Acquisition Circular FAC 05-03. This acquisition will be processed under the North American Industry Classification Systems (NAICS) 325414 code for this acquisition is and the Business Size standard is 500. The period of performance will start day of award thru June 2007 with (2) option years. (NIAID) is soliciting quotations from offerors to acquire a 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 analysis of antibody-dependent enhancement in vitro and in vivo and to validate 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 four IgG antibodies will be produced from their respective plasmid. We expected to obtain 10-25mg of highly purified IgG antibody, each. Four plasmid constructs are designated as follow pIgG 1A5 d1; pIgG 5H2 wt; pIgG 3E4 wt; pIgG 1A10 wt. The Contractor will use a 5-L culture of T293 cells for production and purification of each monoclonal antibody. The yield is expected to be in the range of 10-25mg of IgG antibody each. The Contractor will provide a written report of the data analysis also 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), with its extensive work in the area of vaccine development including preclinical and clinical trails, 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 experiment in vitro functional characterizations and animal protection studies. Kemp Biotechnologies has been used in the past and has developed a protocol for cultivating suspension cell lines in scalable systems, suitable for this production. Changing variable at this time would prevent correct interpretation of the experiments 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 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; and FAR 52.204-7 Central Contractor Registration (CCR). 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), June 19, 2006 to Mrs. Tawana Parker. Copies of the aforementioned clauses are available upon request by telephone to Mrs. Tawana Parker at (301) 594-3419. For deliver through the Postal Service, the address is NIH/NIAID/AMOB, 10401 Fernwood Drive, Room 2NE70G, Bethesda MD 20817-4811. Electronic transmissions will not be accepted. Requests for information concerning this requirement are to be addressed to Mrs. Tawana Parker. Collect calls will not be accepted. All responsible sources may submit an offer that will be considered by this agency.