This Combined Synopsis/Solicitation opportunity from Department Of Health And Human Services was posted on June 23, 2025. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

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Agilent 6560 Ion Mobility LC/Q-TOF System Upgrade

Closed

RFQ25Q1285887Federal

Submission Closed06/25/2025, 02:00:00 PM UTC

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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AI Contract Overview

The contract involves upgrading the existing Agilent 6560B IM-QTOF mass spectrometry platform used by the FDA's DPQR to enhance its capabilities for complex pharmaceutical analysis. The upgrade includes both hardware and software components, notably adding collision-induced unfolding (CIU) functionality to analyze large biomolecules such as antibodies, and integrating a biologic-compatible high-performance liquid chromatography (HPLC) system to improve separation prior to mass spectrometry. The new hardware must be fully compatible with the current system without compromising instrument capacity, and the software should support advanced data analysis, library management, and characterization of various drug products, including peptides, proteins, oligonucleotides, and small molecules. This enhancement aims to bolster the FDA’s ability to characterize complex drug products, address regulatory inquiries, and support the development and review of generics, biosimilars, and emerging drug entities. The project underscores the importance of advanced ion mobility techniques, such as collision cross section measurement and CIU, for structural elucidation and higher-order structure analysis, which are critical for regulatory assessments of complex pharmaceuticals.

General Info

DPQR seeks hardware/software upgrades for Agilent 6560B, adding CIU cell and UPLC system integration.

Agency

Department Of Health And Human Services → FDA Office Of Acq Grant Svcs

NAICS

334516 - Analytical Laboratory Instrument Manufacturing

Place of Performance

Silver Spring, MD, 20993, USA

Set-Aside

NONE

Documents

FDA-RFQ-25Q1285887 Agilent 6560 Ion Mobility LC/Q-TOF System Upgrade

rfq

High

AI Contract Breakdown

Uniform Contract Format

Contract not broken down yet

CLEATUS splits the solicitation into Uniform Contract Format (UCF) sections: scope, pricing, deliverables, and evaluation criteria.

Timeline

3 updates

PhaseClosed

PostedJun 13

Combined Synopsis

Deadline changedJun 23

Response deadline changed from Jun 23, 2025 to Jun 25, 2025.

Deadline changedJun 23

Response deadline changed from Jun 25, 2025 to Jun 27, 2025.

Deadline changedJun 23

Response deadline changed from Jun 27, 2025 to Jun 23, 2025.

Response DeadlineJun 25

Deadline has passed

Submission Closed

06/25/2025, 02:00:00 PM UTC

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Organization & Contact Information

AgencyDepartment Of Health And Human Services → FDA Office Of Acq Grant Svcs

Contacts1 person available

OfficeBeltsville, MD, 20705, USA

Organization / AgencyDepartment Of Health And Human Services → FDA Office Of Acq Grant Svcs

Office AddressBeltsville, MD, 20705, USA

Contacts

Warren Jackson

contact@example.gov

+1 (555) 000-0000

Full 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 mass spectrometry data. This platform will advance DPQR's analytical capability and research readiness to generate critical evidence to support both new, generic, and biosimilar drug applications. Scope To obtain a software and hardware upgrade to the existing Agilent 6560B IM-QTOP System Requirement Contractor shall provide the following salient characteristics to the Agilent 6560B IM-QTOP upgrade: Item 1: Instrument -A hardware upgrade to the Agilent 6560B IM-QTOF instrument allowing for collision-induced unfolding (CIU) capabilities for ions, such as antibodies (MW 150 kDa), from native to their extended conformation states. This upgrade should be fully compatible, both hardware and software, to existing Agilent 6560B platform instrumentation and should not introduce any detriment to instrument capacity. -An ultra performance liquid chromatography (UPLC) system that is biocompatible, have a binary system (1300bar), thermally controlled multiplate sampler (4 C to 40 C) and column compartment (4 C to 60 C), variable wavelength detector, and flex bench mobile cart for easy movement. This UPLC system must be fully compatible, both hardware and software, to existing Agilent 6560B platform instrumentation and easy to swap in/out with the currently linked Agilent RapidFire 365 system. -Required source ion optic hardware needed for analysis of peptide, proteins, antibodies, and oligonucleotides. Item 2: Software -Software that is compatible with data generated from the upgraded Agilent 6560B and purchased UPLC system to allow for data/library management, targeted/non-targeted analysis, peptide/protein analysis, oligonucleotide analysis, compound discovery, etc.