Software with Multiple Licenses to Process HRMS Data (Brand Name or Equal)

Software with Multiple Licenses to Process HRMS Data (Brand Name or Equal) This is a combined/synopsis solicitation issued under FAR Part 12 and 13.5 procedures. This is an unrestricted procurement. The NAICS code is 541519. The Government is in no way obligated to make an award, nor to pay any costs incurred by the Contractor in preparing and submitting its quote. BACKGROUND Developing advanced analytics to improve the characterization of large molecule and complex molecule drugs is one of the research priorities at FDA/CDER in order to support application assessments and establish regulatory guidance and policy. High resolution mass spectrometry (HRMS) and high resolution tandem mass spectrometry (HRMS/MS) are powerful analytical techniques for the analysis of complex molecules and are currently used at CDER/OPQ/OTR (St. Louis) to characterize complex drug products including proteins, peptides, and oligonucleotides. The acquired HRMS and HRMS/MS data are highly complex and contain detailed compositional and structural information which needs to be processed by specialized software to be understandable and manageable. In addition, the amount and diversity of data to be processed and the demand for rapid analysis requires the possession of multiple licenses. The objective of this acquisition is to purchase software with multiple licenses to increase the capacity to process HRMS and HRMS/MS data produced at CDER/OPQ/OTR (St. Louis) and to improve the characterization of complex molecules. Objectives To acquire software with multiple licenses to process the HRMS and HRMS/MS data produced by Thermo Orbitrap-type mass spectrometers at CDER/OPQ/OTR (St. Louis) to support large molecule and complex drug characterization. Scope of Work The vendor is responsible for delivering the software that meets the technical requirements described below and providing technical support to ensure appropriate functionality and usability of the software. Technical Requirements. The software must meet the following requirements: The software must be able to process the HRMS and HRMS/MS data produced by Thermo Scientific Orbitrap-type mass spectrometers which are used at CDER/OPQ/OTR (St. Louis) for data acquisition. The software must be able to perform qualitative and quantitative analyses of HRMS and HRMS/MS data as well as certain level of statistical analyses. The software must be able to perform complete characterization of complex molecules including intact mass analysis, peptide mapping, oligonucleotide analysis, mRNA analysis, top-down and bottom-up analysis or multi-attribute method (MAM) workflows. The software should be able to run on a Microsoft Windows 10 operating system. Trade and Service Criteria Technical support shall be provided at no additional cost during the service period. Deliverables Five licenses of software for processing HRMS and HRMS/MS data produced by Thermo Orbitrap-type mass spectrometers including multiple modules capable of intact mass analysis, peptide mapping, oligonucleotide analysis, mRNA analysis, top-down and bottom-up analysis or multi-attribute method (MAM) workflows, and with no need for periodic renewal with additional costs for appropriate functions.