Thermo Scientific Exactive Plus EMR LC-MS System
| Brand | Thermo Fisher |
|---|---|
| Origin | USA |
| Manufacturer Type | Original Equipment Manufacturer (OEM) |
| Product Origin | Imported |
| Model | Exactive Plus EMR LC-MS System |
| Price Range | USD 140,000 – 280,000 (estimated FOB US port) |
| Instrument Type | Orbitrap-based Liquid Chromatography Mass Spectrometer |
Overview
The Thermo Scientific Exactive Plus EMR LC-MS System is a high-performance benchtop mass spectrometer engineered for structural proteomics, intact protein characterization, and comprehensive small-molecule analysis. At its core lies the Orbitrap mass analyzer—a high-resolution, accurate-mass (HRAM) technology based on electrostatic trapping and image-current detection—delivering mass resolution up to 140,000 FWHM at m/z 200 and sub-3 ppm mass accuracy in standard operating mode. The EMR (Extended Mass Range) option extends the upper mass limit to m/z 6,000, enabling reliable detection and characterization of large biomolecules—including intact monoclonal antibodies (mAbs), PEGylated proteins, multimeric complexes, glycoforms, and viral capsid assemblies—without requiring enzymatic digestion or top-down fragmentation. This capability supports native MS workflows under non-denaturing or mildly denaturing conditions, preserving higher-order structure information critical for biopharmaceutical development and quality control.
Key Features
- Orbitrap mass analyzer with real-time internal calibration (RTC) for continuous mass accuracy stabilization across extended acquisition periods
- Extended Mass Range (EMR) configuration supporting full-scan MS detection from m/z 50 to 6,000—optimized for intact protein and complex biomolecular analysis
- Electrospray ionization (ESI) source with dual-mode polarity switching and robust nanoflow/microflow compatibility
- Integrated HPLC interface compatible with Thermo Scientific Vanquish UHPLC systems for seamless LC-MS coupling and method transfer
- High dynamic range detection with >4 orders of magnitude linear response, suitable for quantitation of co-eluting species in heterogeneous samples
- Benchtop footprint with air-cooled electronics and low helium consumption—designed for routine operation in regulated and academic laboratories
Sample Compatibility & Compliance
The Exactive Plus EMR system accommodates a broad spectrum of sample types: intact proteins (10–600 kDa), antibody-drug conjugates (ADCs), oligomeric protein assemblies, synthetic peptides, metabolites, lipids, and small-molecule pharmaceuticals. It supports both reversed-phase and native chromatography mobile phases—including ammonium acetate buffers (10–200 mM) and volatile organic modifiers—enabling direct transfer of native MS methods from research to QC environments. From a regulatory standpoint, the instrument’s firmware architecture supports audit-trail-enabled data acquisition and processing in accordance with FDA 21 CFR Part 11 requirements when deployed with Thermo Scientific Chromeleon CDS v7.3 or later. System suitability testing, calibration verification, and performance qualification protocols align with ICH Q5E, USP , and ISO/IEC 17025 guidelines for analytical instrument qualification in GLP and GMP settings.
Software & Data Management
Data acquisition and processing are managed via Thermo Scientific Compound Discoverer and BioPharma Finder software platforms. Compound Discoverer enables untargeted screening, molecular formula generation, and retention time alignment for small-molecule applications. BioPharma Finder provides dedicated workflows for deconvolution of charge-state envelopes, glycoform profiling, sequence variant identification, and relative quantitation of post-translational modifications (PTMs). All raw data files (.raw) are stored in a vendor-neutral, timestamped format compliant with ASTM E2524-06 standards. Integrated metadata tagging, user-defined reporting templates, and export options for mzML and imzML formats ensure interoperability with third-party informatics tools and LIMS integration.
Applications
- Intact mass analysis of therapeutic monoclonal antibodies and biosimilars
- Characterization of PEGylation site occupancy and stoichiometry in modified biologics
- Native mass spectrometry of protein-ligand and protein-protein interactions
- Glycoform distribution profiling for cell-line selection and process optimization
- Peptide mapping confirmation and impurity identification in peptide therapeutics
- Small-molecule metabolite identification in ADME and toxicology studies
- Impurity profiling and forced degradation product characterization per ICH Q3B(R2)
FAQ
What is the maximum recommended mass range for intact protein analysis using the EMR option?
The EMR configuration supports full-scan detection up to m/z 6,000, permitting analysis of proteins up to ~600 kDa under optimized native conditions.
Does the system support automated calibration and mass recalibration during acquisition?
Yes—the Real-Time Calibration (RTC) feature uses lock-mass ions from a continuously infused reference compound to correct mass drift without interrupting data collection.
Is the Exactive Plus EMR compliant with 21 CFR Part 11 for electronic records and signatures?
When operated with validated versions of Chromeleon CDS and appropriate procedural controls (e.g., role-based access, audit trails, electronic signatures), the system meets foundational technical requirements for Part 11 compliance.
Can the instrument be coupled with nanoLC or capillary LC systems?
Yes—its ESI source is configurable for nanoflow (50–500 nL/min) and microflow (1–20 µL/min) regimes, supporting direct coupling to Thermo Scientific EASY-nLC and UltiMate 3000 nano/micro systems.
What level of mass accuracy can be expected in routine operation?
Under standard calibration and ambient lab conditions, typical mass accuracy is ≤2 ppm RMS error for peptides and ≤5 ppm for intact proteins over a 24-hour acquisition window.
