SAM #75N98027Q00040

Stability Testing for ManNAc Drug Product from Campaigns 5 and 6

The National Institutes of Health, through the National Human Genome Research Institute, seeks stability testing for ManNAc drug product from Campaigns 5 and 6. - Government buyer: National Institutes of Health (NIH), National Human Genome Research Institute (NHGRI). - OEMs and vendors: No OEMs, vendors, or testing laboratories are named in the notice. - Requested service: Regulatory-compliant stability testing for ManNAc drug product produced in Campaigns 5 and 6; no quantity or part number is specified. - Key requirement: Testing supports an FDA-required stability program for clinical-grade drug product intended for future clinical trials.

Description

INTRODUCTION

THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).

The National Institutes of Health (NIH) intends to negotiate and award a contract without providing for full and open competition (Including brand-name) to:

Alcami Corporation

2320 Scientific Park DR

Wilmington, North Carolina

28405-1800

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 541380 with a Size Standard $16.6M.

REGULATORY AUTHORITY

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2026-01, March 13, 2026. This acquisition is conducted under the procedures as prescribed in FAR subpart 13-Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold ($350,000).

STATUTORY AUTHORITY

This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source and is not expected to exceed the simplified acquisition threshold. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements.

GENERAL INFORMATION

Title: Stability Testing for ManNAc Drug Product produced in Campaigns 5 and 6. Stability testing will occur under regulatory compliance Background Information: NHGRI was gifted 48kg of unlabeled drug ManNAc (powder-in-sachet) in September 2025, and agreed to take over the FDA-required, mandatory, stability testing program of this drug that has been ongoing at Alcami Corporation since June 2024. The gifted drug was produced in 2 campaigns, Campaign 5 (C5, June 2024) and Campaign 6 (C6, September 2024). NHGRI plans to use the donated clinical grade drug for upcoming clinical trials.

CLOSING STATEMENT

This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include a technical proposal, a cost-price proposal, the period of performance, the Unique Entity ID (UEI), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.

All responses must be received by November 9, 2026 at 9:00 AM Eastern time and must reference solicitation number 75N98027Q00040. Responses may be submitted electronically to Mr. James Law, Contracting Officer at James.Law@nih.gov. Fax responses will not be accepted.

"All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency.”

View original listing