Sources Sought Contract Vialing of Monoclonal Antibody
Closed Pre-Solicitation Posted
Not the latest version. See the latest solicitation from .
- Solicitation number
- NB645030-25-01699
- Agency
-
National Institute of Standards and Technology
Department of Commerce
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 325414 Biological Product (except Diagnostic) Manufacturing
- PSC
- AJ12 General Science And Technology R&D Services; General Science And Technology; Applied Research
- Place of performance
- Gaithersburg, Maryland 20899, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The National Institute of Standards and Technology (NIST) is conducting market research to identify potential vendors capable of providing contract vialing services for monoclonal antibody reference materials. This sources sought notice seeks companies that can handle and process two specific monoclonal antibody reference materials (NISTmAb RM 8671 and cNISTmAb RM 8672) with precise specifications for dilution, vialing, and preservation using USP-grade materials while maintaining strict temperature and sterility controls. Interested vendors must demonstrate their capability to maintain protein concentration within 0.5 mg/mL, ensure 95% molecular purity through size exclusion chromatography, and provide comprehensive documentation throughout the process. Responses must include capability statements with company information, manufacturing details, country of origin, specification sheets, typical lead times, and relevant experience, with company sales brochures not being considered. The submission deadline is July 7, 2025, and responses should be sent electronically to Contracting Officer Angela Hitt at angela.hitt@nist.gov.
Currently, no set-aside designation has been determined, though NIST will consider all small business set-aside categories and has indicated that if at least two qualified small businesses are identified, the acquisition will be solicited as a small business set aside under NAICS code 541714 with a size standard of 1,000 employees. No incumbent contractors or potential award values are specified in this pre-solicitation notice. The contract requires production of 40,000 total vials across two separate lots: 30,000 vials of RM 8671 and 10,000 vials of PS 8670, each at a 10 mg/mL concentration using Thermo matrix vial systems. The performance period spans 18 months with deliverables due within 90 days after material shipment, and contractors must provide progress reports every two weeks while attending kick-off and status meetings. The procurement falls under NAICS code 541714 for Research and Development in Biotechnology, emphasizing the specialized nature of this biotechnology manufacturing requirement.
Notice text
2 versions
Update #2 · Latest ·
The purpose of Amendment 1 is to change the NAICS code 541714 to 325414. All other terms and conditions remain unchanged.
National Institute of Standards and Technology (NIST)
Acquisition Management Division
Sources Sought for Commercial Product Purchase
THIS SOURCES SOUGHT IS NOT A REQUEST FOR QUOTATION.
It is a market research tool being used to determine potential and eligible business firms that can provide the product described herein prior to determining the method of acquisition.
The National Institute of Standards & Technology (NIST) seeks information on vendors that can provide Contract Vialing of Monoclonal Antibody Reference Material per the specifications attached herein.
This announcement is not a Request for Proposals or Quotes (RFP/RFQ) and does not commit the Government to award a contract now or in the future. The information contained in this notice is DRAFT only and, as such, is subject to change prior to the issuance of a solicitation. No solicitation is available currently. Additionally, the Government is not obligated to and will not pay for any information received from potential sources because of this Sources Sought announcement. The results of this Sources Sought will be utilized to determine if any Small Business Set-aside opportunities exist. All Small Business Set-aside categories will be considered. In addition, this market research tool is being used to identify potential and eligible firms, of all sizes, who manufacture in the U.S. prior to determining the method of acquisition and issuance of a solicitation.
After the results of this market research are obtained and analyzed, NIST may conduct a competitive or non-competitive procurement on the System for Award Management (sam.gov) and subsequently award a contract. If at least two qualified small businesses are identified during this market research stage that can fulfill the requirement, in accordance with the Specifications, then this acquisition shall be solicited as a small business set aside, however, NIST is seeking responses from ALL responsible sources, including large and small businesses. Responses should include the country where the product is manufactured.
This requirement is assigned a NAICS code of 541714, Research and Development in Biotechnology (except Nanobiotechnology), with a small business size standard of 1,000 employees.
Interested business organizations that believe they can meet the requirements should submit electronic copies of their capability statement. Responses should include the following information:
- Name of the company that will provide the product(s).
- Name of the company that will manufacture the product.
- County of origin or manufacture of the product.
- Spec/data sheets and examples of products that meet the specifications that demonstrate experience in meeting the requirements of this procurement.
- Typical lead time to deliver the product after receipt of order
- Any other relevant information that is not listed above that the Government should consider in developing its minimum specifications and finalizing its market research.
(Company sales brochures or marketing packages will not be considered.)
Any proprietary information should be so marked. The written capability statement should be received by the Contracting Officer, Angela Hitt, via email at angela.hitt@nist.gov no later than the date and time posted in this notice. No quotes will be accepted at this time and will not be considered.
REQUIREMENTS OVERVIEW:
See the attached Statement of Work document.
Update #1 ·
National Institute of Standards and Technology (NIST)
Acquisition Management Division
Sources Sought for Commercial Product Purchase
THIS SOURCES SOUGHT IS NOT A REQUEST FOR QUOTATION.
It is a market research tool being used to determine potential and eligible business firms that can provide the product described herein prior to determining the method of acquisition.
The National Institute of Standards & Technology (NIST) seeks information on vendors that can provide Contract Vialing of Monoclonal Antibody Reference Material per the specifications attached herein.
This announcement is not a Request for Proposals or Quotes (RFP/RFQ) and does not commit the Government to award a contract now or in the future. The information contained in this notice is DRAFT only and, as such, is subject to change prior to the issuance of a solicitation. No solicitation is available currently. Additionally, the Government is not obligated to and will not pay for any information received from potential sources because of this Sources Sought announcement. The results of this Sources Sought will be utilized to determine if any Small Business Set-aside opportunities exist. All Small Business Set-aside categories will be considered. In addition, this market research tool is being used to identify potential and eligible firms, of all sizes, who manufacture in the U.S. prior to determining the method of acquisition and issuance of a solicitation.
After the results of this market research are obtained and analyzed, NIST may conduct a competitive or non-competitive procurement on the System for Award Management (sam.gov) and subsequently award a contract. If at least two qualified small businesses are identified during this market research stage that can fulfill the requirement, in accordance with the Specifications, then this acquisition shall be solicited as a small business set aside, however, NIST is seeking responses from ALL responsible sources, including large and small businesses. Responses should include the country where the product is manufactured.
This requirement is assigned a NAICS code of 541714, Research and Development in Biotechnology (except Nanobiotechnology), with a small business size standard of 1,000 employees.
Interested business organizations that believe they can meet the requirements should submit electronic copies of their capability statement. Responses should include the following information:
- Name of the company that will provide the product(s).
- Name of the company that will manufacture the product.
- County of origin or manufacture of the product.
- Spec/data sheets and examples of products that meet the specifications that demonstrate experience in meeting the requirements of this procurement.
- Typical lead time to deliver the product after receipt of order
- Any other relevant information that is not listed above that the Government should consider in developing its minimum specifications and finalizing its market research.
(Company sales brochures or marketing packages will not be considered.)
Any proprietary information should be so marked. The written capability statement should be received by the Contracting Officer, Angela Hitt, via email at angela.hitt@nist.gov no later than the date and time posted in this notice. No quotes will be accepted at this time and will not be considered.
REQUIREMENTS OVERVIEW:
See the attached Statement of Work document.
Files
| File | Type | Posted |
|---|---|---|
| NB645030-25-01699 Statement of Work.pdf |
Notice history
| Notice | Type | Posted |
|---|---|---|
| Vialing of Monoclonal Antibody | Solicitation | |
| This notice | Pre-Solicitation |
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