Inactive

High Resolution Demultiplexing (HRdm) Software - 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 NAI... High Resolution Demultiplexing (HRdm) Software - 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 small business size standard is 150 employees. 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 Please submit your question to Lilibeth Deato@fda.hhs.gov by August 17, 2022, 4:00PM EDT. Please submit your RFQ response to Lilibeth Deato@fda.hhs.gov by Jul August 26, 2022 2:00 pm EDT BACKGROUND Developing suitable analytical tools to advance the characterization of protein therapeutics and complex molecule drugs is one of the research priorities at FDA/CDER to support application assessments and establish regulatory guidance and policy. Ion mobility - high resolution mass spectrometry (IMS-HRMS) is a powerful analytical technique to characterize chemical compositions and structures at the molecular level. IMS is an ultra-fast separation technique that separates molecules in the gas phase on a millisecond time scale according to their charge, shape and size. Addition of IMS separation prior to HRMS detection complements the accurate mass measurements obtained by HRMS by potentially differentiating compounds of the same mass but different structures and providing structural information at the same time. Therefore IMS-HRMS is becoming increasingly used in characterizing protein therapeutics and complex drugs. CDER/OPQ/OTR Saint Louis lab is currently using an Agilent 6560 ion mobility Q-TOF LC/MS system to analyze protein therapeutics and complex drugs. The acquired IMS-HRMS data needs to be processed by specialized software to produce relevant and useful information. IMS resolution of closely related molecules is an output from the data processing and a high resolution is desirable to uncover enriched chemical and structural information. However, the software currently in use is only able to produce low resolution data output leaving a fair amount of the useful information in IMS-HRMS data not studied. The objective of this acquisition is to purchase a software that can process multiplexed IMS-HRMS data acquired by Agilent 6560 LC/MS to improve the IMS resolution output and hence overall quality of data output for better characterization of protein therapeutics and complex drugs. Project Objectives To acquire a software to process the multiplexed IMS-HRMS data produced by Agilent 6560 ion mobility Q-TOF LC/MS system for increased IMS resolution output to support the characterization of protein therapeutics and complex drugs. 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 multiplexed IMS-HRMS data produced by an Agilent 6560 ion mobility Q-TOF LC/MS system to provide high resolution IMS data of at least 200 across the entire mobility range. The software must be able to process retrospectively previously collected multiplexed datafiles from an Agilent 6560 ion mobility Q-TOF LC/MS system. 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.