Inactive

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... 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.