High Resolution Mass Spectrometer

The contract involves the acquisition of a high-resolution LC-HRMS system designed to offer exceptional sensitivity for genotoxic impurity testing and impurity profiling of complex drug products, including peptides and proteins. This instrument is essential for meeting the increasing analytical demands posed by complex pharmaceuticals, supporting the FDA's mission to ensure the safety and quality of a growing segment of the U.S. drug supply. It enables high throughput analysis, enhancing the efficiency of laboratory workflows. The included software package facilitates advanced mass spectrometry data analysis for biopharmaceutical characterization and adds functionality to process oligonucleotide data, thereby broadening the FDA's capability in evaluating drug quality. The system primarily supports user fee programs under GDUFA (Generic Drug User Fee Amendments) and OMUFA (Original Manufacturer User Fee Amendments), targeting regulatory needs related to generic and original drug approvals. The contract forecast was posted in March 2026 by the Food and Drug Administration and pertains to the NAICS code 334516, which covers analytical laboratory instrument manufacturing. Contact points include a CDER Acquisition Liaison for program inquiries, with contracting officer details yet to be determined. This acquisition aligns with the FDA’s ongoing commitment to advance analytical technologies for complex drug evaluation.