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

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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