Stability Testing for ManNAc Drug Product produced in Campaigns 5 and 6. Stability testing will occur under regulatory compliance
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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 STATE…