SPECIAL NOTICE
68 -- Intent to Sole Source - Immunoreagents for Algal Toxin Sensors on Environmental Sample Processor (ESP) Platform
- Notice Date
- 1/30/2023 1:01:42 PM
- Notice Type
- Special Notice
- NAICS
- 325413
— In-Vitro Diagnostic Substance Manufacturing
- Contracting Office
- NATIONAL OCEANIC AND ATMOSPHERIC ADMINISTRATION US
- ZIP Code
- 00000
- Solicitation Number
- 1333MG-23-Q-00400
- Response Due
- 2/14/2023 8:00:00 AM
- Point of Contact
- Scott Beliveau
- E-Mail Address
-
scott.beliveau@noaa.gov
(scott.beliveau@noaa.gov)
- Description
- The US Department of Commerce (DOC), National Oceanic and Atmospheric Administration (NOAA), National Centers for Coastal Ocean Science (NCCOS), Business Support Branch intends to negotiate on a sole source basis, under the statutory authority of FAR 13.106-1(b)(1)(i), with The Queen�s University Belfast School of Biological Sciences Research� & Enterprise, to procure multiple immunoreagents (antibodies and toxin-protein conjugates) for incorporation into NCCOS-designed algal toxin sensors integrated with the 2nd and 3rd Generation Environmental Sample Processor platforms.� NCCOS-designed algal toxin sensors integrated with the 2G-ESP and 3G-ESP platforms are formatted for membrane-based protein arrays and surface plasmon resonance (SPR) chips, respectively. The former are fabricated by employing custom-designed �inks� formulated with the specially-designed toxin-protein conjugates identified above and used in the printing of low-density array feature maps on membrane discs, whereas the latter are made by chemically immobilizing native toxin molecules on the appropriately prepared gold surface of SPR chips. In both cases, proprietary monoclonal antibodies designed specifically for recognizing and binding to these target toxins represent the critical �recognition element� around which these sensors are designed, optimized, and validated over many years (1000s of hours) of R&D efforts. Thus, it is critical for the functioning of these algal toxin sensors at the required performance specifications that these same immunoreagents produced by QUB (based on proprietary chemistry) be used in their continued fabrication in order to support essential, operational field deployments of 2G- and 3G-ESPs. Given that the current stock of these custom-designed QUB immunoreagents is insufficient for NOAA/NCCOS scientists to fully meet their funded programmatic obligations and project deliverables, procurement from the Contractor of the immunoreagents identified and described below (including quantity of each required) is essential to fulfilling NOAA�s mission requirements. The proprietary immunoreagents described above as acquired from Queen�s University Belfast were employed in the original design, optimization, and validation of algal toxin sensors integrated with the 2G-and 3G-ESP instruments and have demonstrated the ability to meet required performance specifications for these systems, with toxin detection limits (in extract) in the low nanogram per milliliter range and a linear dynamic range of at least 1-1.5 orders of magnitude. Antibodies shall be provided in lyophilized form in 1 milligram aliquots and toxin-protein conjugates shall be provided in lyophilized form to be resuspended to a working concentration of 1 milligram per milliliter in the vial or tube containing the material. The North American Industry Classification Code (NAICS) for this acquisition is 325413, In-Vitro Diagnostic Substance Manufacturing, with a business size standard of 1250 employees. Sole Source Justification Several proprietary immunoreagents custom-designed by Queen�s University Belfast (QUB), including monoclonal antibodies produced against the algal toxins domoic acid (DA), saxitoxin (STX), and microcystin (MC), as well as the toxin-protein conjugates DA-ovalbumin and STX-ovalbumin, were used over the past two decades by NOAA/NCCOS scientists in the original design and optimization of sensors used to detect and measure algal toxins present in coastal marine and Great Lakes environments. These highly specialized toxin sensors, developed as part of a decades-long, highly successful R&D program, are deployed as integral components of the 2nd and 3rd Generation Environmental Sample Processors (2G-ESP; 3G-ESP) and represent the centerpiece of these uncrewed observing platforms� monitoring capabilities, necessary to support NOAA�s mandate under the Harmful Algal Bloom and Hypoxia Research and Control Act (HABHRCA; Public Law 115-423). The customized chemistry protocols employed to produce these immunoreagents, including synthesis of toxin-protein conjugates for direct use in our sensors or as immunogens to generate monoclonal antibodies, were developed by and are proprietary to QUB. Although there exist many commercial suppliers of custom immunoreagents, 1000�s of research and development (R&D) hours have gone into evaluating, optimizing, and validating the performance specifications of the QUB-produced immunoreagents specifically on NCCOS-developed algal toxin sensors. Therefore, in the absence of re-investing a highly significant number of extremely costly person hours for evaluating a series of new products, it is deemed that no company or group other than QUB is capable of confidently providing the suite of immunoreagents required to satisfy the performance requirements of our multiple NCCOS toxin sensors now being deployed operationally in multiple locations around the Nation�s coastal waters. The inability to deploy functional algal toxin sensors due to a lack of reliable QUB immunoreagents will preclude NOAA/NCCOS scientists from fully meeting their funded programmatic obligations and project deliverables essential to fulfilling NOAA�s mission requirements. Special Notice This special notice is not a solicitation for competitive quotes, nor will one be posted on Contract Opportunities.� However, if an interested party believes that it is capable of meeting the requirements and be in compliance with the above justification, they may submit substantiating documentation in writing within the open period of this notice.� Responses can be sent via e-mail to scott.beliveau@noaa.gov . �Documentation will be evaluated solely for the purpose of determining whether or not to conduct this procurement on a competitive basis. A determination by the Government not to conduct a competitive procurement, based upon response to this notice, is solely within the discretion of the Government. Oral communications are not acceptable in response to this notice. All responsible sources may submit a Capability Statement in accordance with the solicitation, which shall be considered by the agency if received on or before 11:00 AM EDT on February 14, 2023.� The Capability Statement must contain material in sufficient detail to allow NOAA to determine if the party can meet all of the requirements.� All electronic correspondence shall have the subject line read:� Announcement Number: 1333M2-23-Q-00400 Project Title: Immunoreagents for Algal Toxin Sensors on Environmental Sample Processor (ESP) Platform It is the Contractor�s sole responsibility to ensure that any correspondence, transmitted to the specified Government representative(s) is received prior to the due date specified herein.� The Government representative(s) will verify receipt of your email, if notification is not received within 24 hours of your email,� DOC/NOAA/NCCOS Business Support Branch requires that all contractors doing business with this office be registered with the System for Award Management (SAM). No award can be made to a company not registered in SAM. For additional information and to register in SAM, please access the following web site: www.sam.gov. The notice will remain open from 1/30/2023 to 2/14/2023.
- Web Link
-
SAM.gov Permalink
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- Record
- SN06576393-F 20230201/230130230103 (samdaily.us)
- Source
-
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