Acquisitions Management Operations Branch, NIAID, 6003 Executive Blvd, Solar Building, Room 1C38, Contracts Section, Bethesda, MD 20892-7605

B -- SPECIAL STUDIES AND ANALYSIS-NOT R&D SOL N019902 DUE 122298 POC Hanif S. Abdul-Amin, PA 301-496-2607, Debora Pitts, Contracting Officer, 301-402-2282 This is a combined synopsis/notice of the intent to procure a commerical item prepared in accordance with the format in subpart 12.6, as supplemented with additional information included in this notice. The National Institute of Allergy and Infectious Diseases intends to procure the production of recombinant bMSP-1 as protein vaccine from DynCorp. The service will entail the production of recombinant merozoite surface protein type 1(bMSP-1) truncated 42kD protein (P.falciparum)expressed from baculovirus-infected insect cells at DynCorp in accordance with cGMP guidelines. Working cell banks of Sf-9 cell lines shall be prepared from master cell bank (#235) stored on site at DynCorp. Working virus stocks of recombinant baculoviruses expressing bMSP-1 protein in the culture media of insect cells shall be prepared from the master virus stock. A pilot lot of recombinant bMSP-1 protein shall be prepared for Sf-9 insect cells infected with bMSP-1. Recombinant MSP-1 protein shall be purified from infected cell culture media by immobilized metal affinity chromatography and other steps to be developed. The final bulk product of the pilot lot shall be subject to safety and analytical testing in accordance with 21 CFR regulations for parenteral products and further characterization of the protein product. Final product specifications shall be established joinly by DynCorp and NIH. Manufacturing SPO's and batch records shall be developed and made available to NIH for review. A final report of manufacturing and testing shall be submitted to NIH. SEE NUMBER 22 the provision at 52.212-2, Evaluation-Commerical Items, applies to this acquisition. The government shall award a fixed price purchased order to the responsible contractor. The clause at 52.212-4, Contract terms and conditions-Commerical Items applies to this acquisition. The clause at 52-212-5, Contract terms and conditions required to Implement Statures or Executive Orders-Commerical Items applies to this acquisition. The clauses of subpart(b), which apply, are 6 & 10. Delivery shall be completed sixty (60) days after award to: NIH/NIAID, 9000 Rockville Pike, Building 9, Bethesda, Md 20892. Any response is due no later than 3:00pm, Eastern Standard Time December 22, 1998, to Hanif S. Abdul-Amin. For delivery through the postal service the address is room 1C38, Solar Building, NIH/NIAID, 6003 Executive Blvd., Rockville, Md 20852-7605. Posted 11/24/98 (W-SN274517). (0328)

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