The Centers for Disease Control and Prevention (CDC), National Center for Environmental Health(NCEH), intends to award a sole source contract to Thermo Fisher Scientific, 3747 N. Meridian Rd., Rockford, IL, 61101-9316 for the acquisition of the synthesis and delivery of 275 vials of monoclonal anti-butyrylcholinesterase antibody (200ug/vial).

The statutory authority for this sole source acquisition is 10 U.S.C 2304(c)(1) in accordance with FAR Part 6.302-1- only one responsible source and no other supplies or services will satisfy the agency requirement. The NAICS code for this procurement is 325412, Pharmaceutical Preparation Manufacturing. The period of performance for this procurement is 6 months.

Butyrylcholinesterase (BChE) is a highly specific biomarker of exposure to organophosphorus (OP) compounds including organophosphorus nerve agents (OPNAs) and OP pesticides, and CDC currently has developed an emergency response method for assessing human exposure to nerve agents by measuring OPNA-BChE adducts. The currently validated emergency response method relies upon the purification of the exposure biomarker BChE from clinical blood samples using the monoclonal BChE antibody from the 3E8 hybridoma cell line. Thermo Fisher Scientific is the only vendor who has control of this particular cell line and is therefore the only vendor for the monoclonal BChE antibody required by our emergency response method.

The specific 3E8 monoclonal antibody to BChE is the only available product on the market that can specifically and reproducibly detect our protein biomarker. Unlike monoclonal antibodies, polyclonal antibodies are a mixture of antibodies with varying affinities which will translate to unpredictable performance of our CLIA certified, emergency response method.

Thermo Scientific is the only vendor with the specific butyrylcholinesterase antibody from the 3E8 hybridoma cell line. Our emergency response detection method for assessing human exposure to nerve agents was validated using this monoclonal BChE antibody from Thermo Fisher Scientific.

As a result of this synopsis, no competitive solicitation will be posted on FedBizOpps. We will issue only one solicitation to Thermo Fisher Scientific. However, all responsible sources that believe they can meet these requirements may submit their capabilities/qualifications statement to provide the services to Vallerie Redd via email ONLY at [email protected] with the solicitation number 49433 referenced in the subject line NO LATER THAN September 26, 2012.

A determination by the Government not to compete this proposed action will be based on responses to this notice and are solely within the discretion of the Contracting Officer. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement.

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