RFP ANNOUNCEMENT: HUMANIZED/HUMAN MONOCLONAL ANTIBODY PRODUCTION FACILITY- NIH-NIAID-DMID-03-32 Release Date: August 30, 2002 NOTICE: NOT-AI-02-049 National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov) Receipt Date: November 29, 2002 DESCRIPTION The Division of Microbiology and Infectious Diseases of the National Institute of Allergy and Infectious Diseases (NIAID) has a requirement to select a Prime Systems Contractor (PSC) who will establish an Antibody Production Facility (APF) that will produce fully-human monoclonal antibodies (mAbs) and/or polyclonal antibodies (pAbs) or single chain variable fragments (scFvs) for the Division of Microbiology and Infectious Diseases (DMID), NIAID. The APF will also be required to convert murine mAbs to chimeric or humanized mAbs, as wells as produce chimeric and humanized Abs. Abs must be produced under current good manufacturing practice (cGMP) conditions as required for Phase I/ II clinical trials. The first products required by DMID are likely to include therapeutic Abs against anthrax toxin, the seven serotypes of botulinum toxin, and vaccinia virus. The Government contemplates awarding one (1) indefinite-delivery, requirements cost-type contract for accomplishing the tasks outlined in the Work Statement. It is anticipated that a five-year contract will be awarded with options to continue performance for two additional years. The initial Basic Award (Task 1) of this contract will be for the production of 2 Abs per year. Additional tasks may be issued for increased quantities of Abs as needs arise. Another part of this statement of work is to produce large quantities of products (e.g. 100,000 to 1,000,000 doses) of Abs capable of neutralizing a NIAID Category A, B or C pathogen or toxin (http://www2.niaid.nih.gov/Biodefense/bandc_priority.htm), for a National Stockpile. These tasks for producing products for a National Stockpile will only be initiated if necessary. RFP-NIH-NIAID-DMID-03-32 will be available electronically on or about August 29, 2002, and may be accessed through the NIAID Contract Management Branch (CMB) Home Page at http://www.niaid.nih.gov/contract and will be posted on FedBizOpps at http://www.fedbizopps.gov/. Responses to this RFP will be due on November 29, 2002. Any responsible offeror may submit a proposal for consideration by the Government. This advertisement does not commit the Government to award a contract. No collect calls will be accepted. Contracting Office Address: National Institutes of Health National Institutes of Allergy and Infectious Diseases Contract Management Branch 6700-B Rockledge Drive Room 2230, MSC 7612 Bethesda, MD, 20892-7612 Point of Contact: Elizabeth Osinski, Contract Specialist, Phone 301-402-6289, Fax 301-402-0972, Email eo43m@nih.gov Lawrence Butler, Contracting Officer, Phone 301-496-0192, Fax 301-402-0972, Email lb13t@nih.gov
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