Procurement Summary
Country : USA
Summary : Agilent 6560 Ion Mobility LC/Q-TOF System Upgrade
Deadline : 27 Jun 2025
Other Information
Notice Type : Tender
TOT Ref.No.: 121435259
Document Ref. No. : RFQ25Q1285887
Financier : Self Financed
Purchaser Ownership : Public
Tender Value : Refer Document
Purchaser's Detail
Name :Login to see tender_details
Address : Login to see tender_details
Email : Login to see tender_details
Login to see detailsTender Details
Description
Background
DPQR is requesting a suite of hardware and software updates to our Agilent 6560B ion mobility high resolution quadrupole time-of-flight mass spectrometer (IM-QTOF) platform to address the increasing regulatory research needs and sample testing requests for the evaluation of complex pharmaceutical drug products, e.g. complex generics, biosimilars, and emerging drug entities. Mass spectrometry is a tool for measuring molecular mass information of various types of drug products: small molecules, peptides, proteins, oligonucleotides, etc. Recent advances of integrating ion mobility with mass spectrometry provides additional information regarding the analytes- gas phase collision cross section (CCS) which can be used to infer various structural information of the analyte as well as possible isomer identification. Advanced ion mobility techniques such as collision-induced unfolding (CIU) can be further used to monitor the conformational dynamics of biomolecules and gain insight into their higher-order structure (HOS). The regulatory evaluation from the perspectives of product characterization, quality control, and sameness or similarity assessment for complex pharmaceutical products has always been challenging due to their complex structure and/or impurity profile. It is critical that the FDA laboratories have the facility and capability to fully characterize the complex drug products which helps address the regulatory inquires and concerns during the review process. Currently, DPQR has an instrument platform consisting of an Agilent 6560B IM-QTOF system connected to an Agilent RapidFire 365 robotic sampling platform. We aim to upgrade the current platform by incorporating a CIU activation cell to our 6560 system and a biologic compatible high performance liquid chromatography system, enabling advanced separation prior to mass spectrometry analysis, through a hardware upgrade as well as software upgrade for interpreting advanced ion mobility...
Active Contract Opportunity
Notice ID : RFQ25Q1285887
Related Notice
Department/Ind. Agency : HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Sub-tier : FOOD AND DRUG ADMINISTRATION
Office: FDA OFFICE OF ACQ GRANT SVCS
General Information
Contract Opportunity Type: Combined Synopsis/Solicitation (Updated)
Updated Published Date: Jun 23, 2025 10:20 am EDT
Original Published Date: Jun 13, 2025 08:20 am EDT
Updated Date Offers Due: Jun 27, 2025 10:00 am EDT
Original Date Offers Due: Jun 23, 2025 10:00 am EDT
Inactive Policy: 15 days after date offers due
Updated Inactive Date: Jul 12, 2025
Original Inactive Date: Jul 08, 2025
Initiative: None
Classification
Original Set Aside:
Product Service Code: 6640 - LABORATORY EQUIPMENT AND SUPPLIES
NAICS Code: 334516 - Analytical Laboratory Instrument Manufacturing
Place of Performance: Silver Spring, MD 20993 USA
Documents
Tender Notice
Combined-Sysnopsis-Upgrade-to-Agilent-6580B-IM-QTO.pdf