ANTIBODIES FOR BREVETOXIN DETECTION

THIS IS A COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL SERVICES PREPARED IN ACCORDANCE WITH THE FORMAT IN FAR SUBPART 12.6, AS SUPPLEMENTED WITH ADDITIONAL INFORMATION INCLUDED IN THIS NOTICE. THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION; QUOTES ARE BEING REQUESTED AND A WRITTEN SOLICITATION WILL NOT BE ISSUED. The Request for Quotation (RFQ) number for reference is EE-133C-14-RQ-0872. In accordance with FAR 19.5 this action is reserved exclusively for small business concerns. The U.S. Dept. of Commerce, NOAA, National Ocean Service, NCCOS, Center for Coastal Fisheries and Habitat Research (CCFHR), Beaufort Laboratory, Beaufort, NC has a requirement for unique Mouse Monoclonal Antibodies capable of detecting Brevetoxin. Product to be provided in accordance with the attached Statement of Work. Statement of Work: Provide purified monoclonal antibodies which specifically bind brevetoxins 2 and 3, the toxins which cause neurotoxic shellfish poisoning. (we are requesting specific chemical reagents be provided) Requirements: The vendor shall provide the NOAA Center for Costal Fisheries and Habitat Research with three separate purified monoclonal antibodies which bind brevtoxin-2, 3. The monoclonal antibodies will be used in our laboratory to detect low levels brevetoxin in environmental samples. Background: Monoclonal antibodies are used to detect specific molecules at low concentration. The production of monoclonal antibodies is a standardized procedure. In this case, brevetoxin-2 and brevetxoxin 3 (slightly different structural forms of the toxin) will be chemically attached to carrier molecules such as bovine serum albumin (BSA) or glucose oxidase (GOx). The chemically attached brevetoxin-carrier molecule will then tested for stability. If stable, the brevetoxin-carrier molecule will be purified. Small amounts of the purified brevetoxin-carrier molecule would then injected into 10 or more mice over a period of months. The immune system of the mice respond as if they had been infected by a bacteria or virus and produce B-cells which secrete antibodies designed to attach the foreign substance, in this case the brevetoxin-carrier molecule. Attaching the brevetoxin molecules to the carrier molecule makes them much more antigenic. The mice are then periodically tested to using a screening assay which in this case will involve attachment of the reporter molecule horse radish peroxidase or other reported molecule to brevetoxin-2 and -3. Once it has been confirmed that B-cells from the different mice are producing monoclonal antibodies specific to brevetoxin-2 and -3, the B-cells from those mice are collected and fused with an immortal mouse cancer cells. These fused cells, known as hybridomas, are diluted, plated out in media, and allowed to form well-separated colonies. Some of hybridomas will secrete antibodies highly specific for the brevetoxin-2 and -3. Each hybridoma secretes only one type of antibody which is why they are called monoclonal (= one clone) antibodies. These colonies can be identified using the same screening assay used to test whether the mice were producing B-cells. Once a group of hybridomas are produced, they will need to be screened to identify three separate antibodies which have the following properties. Again, the screening should be done by using a brevetxoin -2 and -3 coupled to horse radish peroxidase or other brevetoxin-2, -3 reporter molecule construct. By allowing a fixed amount of the brevetoxin-2, -3 horse radish peroxidase construct with different amounts of unlabeled brevetoxin-2, and -3 for the monoclonal antibodies from the various hybridomas it is possible to determine at what level the antibody can detect brevetoxin-2 and -3. The three monoclonal antibodies to be provided to NOAA by the vendor should: (1) Bind both brevetoxin -2 and -3 with similar efficiency, i.e. the estimated efficiency with which each monoclonal antibody binds brevetoxin-2 should be within 85% to 100% that at which it binds brevetoxin-3 and vice versa. (2) The three monoclonal antibodies will to be demonstrated as capable of detecting brevetoxin 2 and brevtoxin 3 at a concentration of 0.3 parts per billion in seawater. (3) The lowest concentration at which each of the monoclonal antibodies provided to NOAA detects brevetoxin-1 (which is sometimes seen in environmental samples at low concentration) will have to be determined and that information provided to NOAA as part of the contract. For each of the three monoclonal antibodies meeting the three criteria stated above, the vendor will supply at least 5 milligrams of purified monoclonal antibody. The vendor will also supply 0.5 milligrams of stable (>95% of the label remains attached after 3 months) horse radish peroxidase labeled brevetoxin-2 which can be used in combination with the three monoclonal antibodies to detect low concentrations of brevetoxin in environmental samples. The vendor will have to submit a quality assurance report containing the following information: 1) Detailed description of how the specificity of the monoclonal antibodies for brevetoxin-2 and -3 was determined. 2) Detailed description of how the binding efficiency of the monoclonal antibodies for brevetoxin-1, -2 and -3 was determined. 3) Detailed protocol describing how the brevetoxin-2 reporter molecule was developed and how it's percent stability was determined along with recommended storage conditions. 4) Test results demonstrating that the each of the three monoclonal antibodies can detect 0.3 ppb of brevetoxin-2 and brevetoxin-3 in seawater. 5) Test results demonstrating that the binding efficiency (ability to detected the same amount of toxin) of each of the three monoclonal antibodies for brevetoxin-2 is within 85% of that for brevetoxin-3 and vice versa. 6) Test results showing the % binding for each of the monoclonal antibodies for brevetoxin-1 relative to brevetoxin-2. IT SECURITY REQUIREMENTS: The Certification and Accreditation (C&A) or Assessment and Authentication (A&A) requirements of Clause 48 CFR 1352.239-72 do not apply, and a Security Accreditation Package is not required. This procurement is being solicited as Small Business set- aside in full and open competition. The resulting purchase order will be negotiated as a firm-fixed price Purchase Order. Hard copies of the RFQ will not be issued. Electronic submission of the contractor's proposal is hereby authorized, but must be transmitted by the posted response date and time. To be eligible for award, offerors must be registered in the System for Award Management (SAM) to be considered for an award of a federal contract. For information regarding registration in SAM contact the SAM website at www.sam.gov/portal/public/SAM/; offerors must also obtain a Data Universal Numbering System (DUNS) number and provide it with the offer. All responsible sources may submit a quote, which shall be considered by the agency. The FSC for this is R425, the NAICS Code is 541380 and the UNSPSC is 81102600, small business size standard is $15.0 MIL. The government intends to award a firm-fixed price purchase order for this requirement. Incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-74. Offerors must comply with the following commercial item terms and conditions. FAR 52.212-1 Instructions to Offerors-Commercial, applies to this acquisition. Evaluation will be in accordance with FAR 52.212-2 Evaluation-Commercial Items. Award will be made to the responsible, responsive offeror whose offer will result in the lowest technically acceptable price and who can best meet the required location. FAR 52.212-4, Contract Terms and Conditions-Commercial Items and 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (MAY 2014) applies and the following additional FAR clauses cited in the clause at paragraph (b) are applicable to this acquisition, as such consider the following clauses checked, (10),(12i), (25), (28), (29), (30), (31), (33), (40), (44) and (50). The following addenda or additional terms and conditions apply; None. No Defense Priorities and Allocations System (DPAS) rating is assigned. Offers must be submitted to the Center for Coastal Fisheries and Habitat Research, 101 Pivers Island Road, Beaufort, NC 28516-9722 by 2:00 P.M. AUGUST 19, 2014. Vendors whose offer expires prior to closing date will not be accepted. Offers maybe sent via email to contact@example.gov. Inquiries will only be accepted via email to contact@example.gov.