National Cancer Institute, Acquisition Management Branch, TBS, 6120 Executive Blvd, EPS/Rm 603 Bethesda, MD 20892-7220

A -- PRODUCTION, PROCESSING AND QUALITY ASSURANCE TESTING OF BIOLOGICAL RESPONSE MODIFIERS SOL N02-CM-17002-54 DUE 102500 POC MaryAnne Golling WEB: http://amb.nci.nih.gov/, http://amb.nci.nih.gov/. E-MAIL: MaryAnne Golling, Contract Specialist (301) 435-3812, mg354x@nih.gov. The Biological Resources Branch (BRB) of the National Cancer Institute (NCI) has the responsibility for preclinical and early clinical evaluation and development of a wide variety of Biological Response Modifiers (BRMs) with potential for cancer therapy. An important aspect of this responsibility is the procurement, processing and quality assurance testing of various BRMs for preclinical and clinical investigations. Specifically, the contractor will provide the services, qualified personnel, equipment, and facilities to produce, purify, and test new BRMs for preclinical laboratory studies and for clinical trials. These BRMs may include protein/peptide vaccines, monoclonal antibodies, immunoconjugates, etc. The contractor will be expected to produce these materials under GLP or GMP guidelines, as instructed by the NCI Project Officer. The contractor will also be expected to aseptically vial BRMs and test these materials for; (1) identity, (2) general safety and (3) microbiological agents following FDA Points to Consider or CFR regulations. Facilities should include secure and air conditioned space for the storage of BRMs under production as well as multiple clean room suites sufficient for the simultaneous processing and vialing of different BRMs under GMP conditions. Because of the nature of this acquisition, offerors submitting proposals must have, or provide evidence that they can establish at time of receipt of FRP by the Contracting Officer; (1) adequate facilities as specified in the solicitation (Statement of Work) in which the Biological Resources Branch can relocate this contract effort within thirty (30) working days after contract award, and (2) because of the need for the pick-up of biologics with a short half-life from the Biological Resources Branch, NCI-FCRDC offerors must demonstrate the capability to pick up biologicals from, and deliver them to, the Frederick Cancer Research and Development Center, Frederick, Maryland 21702-1201 within twenty-four (24) hours. RFP NO2-CM-17002-54 will be issued on or about September 25, 2000 on the NCI web. The Government anticipates a single award on an incrementally funded basis for a period of five years. The Standard Industrial Classification (SIC) code is 8731. No collect calls will be accepted. Posted 08/21/00 (W-SN488129). (0234)

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