SAM #NB645080-26-02073

Sole Source IVT Production and Bottling Service for mRNA Drug-like Substance Material for NIST

This opportunity is a sole source procurement by the National Institute of Standards and Technology (NIST) for mRNA drug-like substance material production and bottling services. - Agency: National Institute of Standards and Technology (NIST), Material Measurement Laboratory (MML), Biomolecular Measurement Division (BMD) - Location: Gaithersburg, MD - Service required: In vitro transcription (IVT) production and bottling of mRNA drug-like substance material - Intended vendor: CellScript, LLC (Madison, WI) - CellScript holds exclusive intellectual property rights and licensing (US Patent 8278036 and US10702600) for producing mRNA with modified uridines for lawful resale and redistribution - Purpose: To create a certified reference standard (SRM) for the biomanufacturing industry and instrument vendors - Supports traceability and quality control for mRNA-based therapeutics - NAICS code: 325414 (Biological Product Manufacturing, except Diagnostic) - Sole source justification: Only CellScript can legally and technically provide the required material - No specific quantities or part numbers provided - Commercial opportunity is limited due to sole source status, but highlights industry need for licensed mRNA production

Technical and business highlights: - The procurement is for a specialized mRNA reference standard, not a commercial therapeutic product - Licensing and IP constraints restrict competition - Opportunity underscores the importance of traceable standards in mRNA manufacturing

Description

FBO ANNOUNCEMENT: PRESOLICITATION NOTICE, NOTICE OF INTENT

ACTION CODE: SPECIAL NOTICE

SUBJECT: Sole source – in vitro transcription (IVT) production and bottling service for mRNA drug-like substance material

SOLICITATION NUMBER: NB645080-26-02073

RESPONSE DATE: 8/25/26

DESCRIPTION:

The National Institute of Standards and Technology (NIST), Material Measurement Laboratory (MML), Biomolecular Measurement Division (BMD) in Gaithersburg, Maryland is responsible for the development of reference standards to accomplish NIST’s mission to support the Biomanufacturing industry and underpin measurements for therapeutics and health, and to carry out sale of standard reference materials in accordance with Code of Federal Regulations 15 CFR Part 230.  The production of an mRNA reference material provides the Biomanufacturing community and instrument vendors a well-characterized, traceable, certified reference standard to underpin critical quality attribute (CQAs) measurement assays for mRNA drug substance.  The reference standard enables quality control of mRNA assays over time and between assays, establishing necessary traceability for assuring safety and supporting regulatory submissions. 

The National Institute of Standards and Technology (NIST) intends to negotiate on a sole source basis, under the authority of FAR Part 12.102(b) with CellScript located in Madison, WI, for this reference material.

Sole Source justification is based on the following:

Market research has shown that CELLSCRIPT, LLC (Madison, WI) is the only known source with the necessary intellectual property rights and licensing authority (USPatent 8278036 and US10702600) to produce and provide mRNA generated by in vitro transcription (IVT) using modified uridines in a manner that permits lawful resale and redistribution through NIST as a Standard Reference Material (SRM).  NIST stakeholders (the biomanufacturing industry) almost exclusively use modified uridines when producing their mRNA-based therapeutics to submit through clinical trials, and require a Reference Standard made with that attribute. 

Although other entities may have the technical capability to synthesize mRNA, they do not possess the required licensing rights for this specific application.  CELLSCRIPT serves as the licensing authority for the relevant patented technology and is the only vendor able to provide the material while ensuring compliance with applicable intellectual property restrictions. 

NAICS code for this requirement will be 325414– Biological Product (except Diagnostic) Manufacturing with a small business size of 1,250 employees.

No solicitation package will be issued. This notice of intent is not a request for competitive quotations; however, interested parties who regard themselves as capable of fulfilling these requirements are invited to submit responses to the Government for consideration. Responses received by 1:00AM EST on 8/25/26 will be considered by the Government.

A determination by the Government not to compete the proposed acquisition based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement.

Inquiry POCs

Erik.Fycklund@nist.gov  Primary

Donald.Graham@nist.gov  Secondary

National Institutes of Standards and Technologies NIST Acquisition Management Division (AMD)

100 Bureau Dr. Mail Stop 1640

Gaithersburg, MD. 20899-1640

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