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High Resolution Mass Spectrometer

Forecast

Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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The Food and Drug Administration is seeking a High Resolution Mass Spectrometer (LC-HRMS) system designed for high sensitivity and high throughput analysis. This equipment is essential for genotoxic impurity testing of human medicines and the impurity profiling of complex drug products, such as proteins and peptides. The system includes specialized software for analyzing mass spectrometry data to characterize biopharmaceuticals, with an updated package specifically for processing oligonucleotide data to enhance laboratory capabilities regarding drug quality. This procurement primarily supports the GDUFA and OMUFA user fee programs, providing the critical data necessary to assess complex drug products that represent a growing portion of the United States drug supply. The contract falls under NAICS code 334516 and is managed by the FDA's Center for Drug Evaluation and Research.

General Info

FDA seeks LC-HRMS system for genotoxic impurity testing and biopharmaceutical profiling.

Agency

Food and Drug Administration → Food And Drug Administration

NAICS

334516 - Analytical Laboratory Instrument Manufacturing

Place of Performance

USA

Set-Aside

NONE

Documents

0

No documents available

Documents will appear here when they are available.

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Organization & Contact Information

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AgencyFood and Drug Administration → Food And Drug Administration

Contacts2 people available

OfficeN/A

Organization / AgencyFood and Drug Administration → Food And Drug Administration

Office AddressN/A

Contacts

Cder Acquisition Liaison

contact@example.gov

To Be Determined To Be DeterminedContracting Officer

Full Description

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LC-HRMS system with high sensitivity to support the needs of genotoxic impurty testing of human medicines and high resolution and high sensitifity needed for impurity profiling of complex drugs (e.g., peptide and protein drug products). The instrument supports the agency mission by providing data needed to assess complex drug products that are an increasing share of the US drug supply. These work-horse instruments have the capability for high throughput analysis. Software is used for the analysis of MS data for the characterization of biopharmaceuticals and the update includes a package for processing oligonucleotide data will imrove agency lab capability to provide needed information on the quality of these complex drugs. The instrument will primarily support GDUFA and OMUFA user fee program needs.

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