Stability Testing for ManNAc Drug Product produced in Campaigns 5 and 6. Stability testing will occur under regulatory compliance
NIH intends a non-competitive award to Alcami Corporation for FDA-required stability testing of ManNAc drug product produced in Campaigns 5 and 6 under regulatory compliance. The drug was gifted to NHGRI (48 kg) and is intended for upcoming clinical trials, with stability testing ongoing at Alcami since June 2024. The procurement is classified under NAICS 541380 with a $16.6M size standard and will use FAR Part 13 simplified procedures at an amount not exceeding $350,000. Performance is associated with Alcami Corporation in Wilmington, North Carolina. Interested parties may submit capability, technical, and cost-price information to establish bona fide capabilities, but the government may proceed non-competitively.