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Purchase of One (1) each Mass Spectrometry Data-Processing software

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General Information

  • Contract Opportunity Type: Combined Synopsis/Solicitation (Original)
  • Original Published Date: Aug 23, 2023 04:57 am EDT
  • Original Date Offers Due: Aug 24, 2023 11:00 am EDT
  • Inactive Policy: Manual
  • Original Inactive Date: Aug 29, 2023
  • Initiative:
    • None

Classification

  • Original Set Aside:
  • Product Service Code: 6695 - COMBINATION AND MISCELLANEOUS INSTRUMENTS
  • NAICS Code:
    • 334516 - Analytical Laboratory Instrument Manufacturing
  • Place of Performance:
    20993
    USA

Description

The U.S. Food and Drug Administration (FDA), the Division of Product Quality Research (DPQR) is requesting mass spectrometry (MS) software to perform data-processing for a Thermo Orbitrap Fusion Lumos MS workstation.

The software will provide comprehensive, automated data-processing workflows for the characterization of biologics including peptide mapping, Host cell proteins (HCP) analysis, multi-attribute method (MAM) method development and non-QC MAM applications. Other important applications will include oligonucleotide impurities and degradation products, identification of proteoforms using top- and middle-down analysis, and accurate intact mass measurements. The software will advance DPQR’s analytical capability to address challenging regulatory science and research studies.

Contact Information

Contracting Office Address

  • 5630 FISHERS LANE HFA-500
  • ROCKVILLE , MD 20857
  • USA

Primary Point of Contact

Secondary Point of Contact





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