Sources Sought Notice.pdf

SOURCES SOUGHT NOTICE

1. Solicitation Number: 1333MG-23-Q-00400

2. Title: Immunoreagents for Algal Toxin Sensors on Environmental Sample Processor (ESP) Platform

3. NAICS Code: 325413, In-Vitro Diagnostic Substance Manufacturing

4. Size Standard: 1250 employees

5. Description: This is a Sources Sought notice. This is NOT a request for quotations. The purpose of this notice is to obtain market research information regarding the availability and capability of all qualified sources that can meet a potential requirement.

This notice is issued to determine the availability of qualified companies technically capable of meeting the Government requirement, to determine the method of acquisition, and availability of domestic sources manufactured in the United States in sufficient and reasonably available commercial quantities and of a satisfactory quality. This notice is not to be construed as a commitment by the Government to issue an RFQ or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for market research and information purposes only.

Small businesses are encouraged to respond.

Responses must include the place of manufacturing (to include address, whether supply/equipment is a domestic end product, and include country of manufacture). For equipment/supply requirements, small businesses must also address the size status of the manufacturer under the applicable NAICS code (i.e.

address Non-Manufacturer Rule).

The response must also include their Unique Entity ID number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HubZone, etc.,) pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements.

Background: 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. Such assets comprise part of NOAA’s harmful algal bloom (HAB) observing and early warning effort mandated under the Harmful Algal Bloom and Hypoxia Research and Control Act

(HABHRCA).

Purpose and Objectives: NOAA/NCCOS scientists require procurement of 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 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.

TECHNICAL SPECIFICATIONS:

The immunoreagents synthesized and provided by the Contractor and shipped to the Government under this award (quantities required given in parentheses) shall meet the following technical specifications and performance level in a competitive immunoassay format:

1. DA-OVA (15 milligrams): domoic acid shall be covalently conjugated to the ovalbumin protein so as to demonstrate maximum interaction (high assay signal strength via secondary antibody- enzymatic chemiluminescent reporting) between the corresponding DA monoclonal antibody (item 2.) and the DA-OVA conjugate as printed on a nitrocellulose membrane-based array;

2.DA McAb (10 milligrams): the monoclonal antibody produced against domoic acid shall have the demonstrated ability to exhibit maximum, specific interaction (high assay signal strength via secondary antibody-enzymatic chemiluminescent reporting) with the corresponding DA-OVA conjugate(item 1.) as printed on nitrocellulose membrane-based arrays and to exhibit maximum, specific interaction (high assay signal strength via surface plasmon resonance relative intensity units) with domoic acid immobilized covalently to a carboxymethyl dextran functionalized gold surface on an SPR sensor chip;

3.STX-OVA (10 milligrams): saxitoxin shall be covalently conjugated to the ovalbumin protein so as to demonstrate maximum interaction (high assay signal strength via secondary antibody-enzymatic chemiluminescent reporting) between the corresponding STX monoclonal antibody(item 4.) and the STX-OVA conjugate as printed on nitrocellulose membrane-based arrays;

4.STX McAb (5 milligrams): the monoclonal antibody produced against gonyautoxin (GTX)2,3 shall have the demonstrated ability to exhibit maximum, specific interaction (high assay signal strength via secondary antibody-enzymatic chemiluminescent reporting) with the corresponding STX-OVA conjugate (item 3.) as printed on a nitrocellulose membrane-based array;

5.MC McAb (10 milligrams): the monoclonal antibody produced against microcystin-LR shall have the demonstrated ability to exhibit maximum, specific interaction (high assay signal strength via surface plasmon resonance relative intensity units) with microcystin-LR immobilized covalently to a carboxymethyl dextran functionalized gold surface on an SPR sensor chip.

The proprietary immunoreagents described above 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.

In case domestic sources are available and capable of fulfilling the Government’s need, and a future solicitation is published, the Government will use evaluation preferences in accordance with FAR 25.

Capability statement /information sought.

Companies that believe they possess the capabilities to provide the required products should submit documentation of their ability to meet each of the project requirements to the Contracting Officer. The capability statement must specifically address each of the project requirements. Additionally, the capability statement should include the professional qualifications of personnel as it relates to the requirements, any contractor GSA Schedule contracts and/or other government-wide acquisition contracts (GWACs) by which all of the requirements may be met, if applicable, and any other information considered relevant. Capability statements must also include the Company

Name, Unique Entity ID from SAM.gov, Physical Address, and Point of Contact Information. The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses.

Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation number.

The response must be submitted to Scott Beliveau, Contracting Officer at scott.beliveau@noaa.gov

The response must be received no later than 11:00am EST on or before February 9, 2023.

Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work.

Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a presolicitation synopsis and solicitation may be published in www.sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation.

mailto:scott.beliveau@noaa.gov