New High-Resolution Mass Spectrometry-Based Workflow Simplifies Biopharmaceutical Characterization and QC

Thermo Scientific HR Multi-Attribute Method provides verified analytical workflow from development to manufacture of protein therapeutics

2 Jun 2019
Aidan Barry
Administrator / Office Personnel

With the launch of a new high-resolution mass spectrometry-based workflow, biopharmaceutical scientists are no longer restricted by the complex series of assays typically required for the characterization and quality control of protein therapeutics.

The Thermo Scientific HR Multi-Attribute Method (MAM) meets the demand for a single, high-resolution mass spectrometry-based workflow designed to directly assess the product quality attributes of increasingly complex biotherapeutics. The workflow replaces the complicated sequence of lower-resolution methods that have previously prolonged characterization timelines. Supported by the Thermo Scientific Chromeleon Chromatography Data System (CDS) software, the HR MAM method simplifies and standardizes biotherapeutic characterization throughout the product pipeline, facilitating the transition of new drugs from initial research to development and manufacture.

Thermo Fisher Scientific is showcasing its new workflow during the 67th American Society for Mass Spectrometry (ASMS) Conference on Mass Spectrometry and Allied Topics, being held June 2–6, in the International Ballroom ABCD at the Omni CNN Center Hotel, Atlanta, Georgia.

Richard Rogers, PhD, Just Biotherapeutics, Inc., said, "Powerful Orbitrap technology and efficient search algorithms, like the one implemented in the BioPharma Finder software, allow us to fully leverage the HR MAM in the characterization of our biotherapeutics. One key component is new peak detection, which is essential for using MAM as a QC release method. The HR MAM contains all of the software components for characterizing and releasing biotherapeutics from QC."

Additionally, companies including Amgen and Pfizer are testing and, in some cases, implementing MAM with Thermo Fisher Scientific products for their analytical processes.

"As a trusted partner of the biopharmaceutical industry, we appreciate that the ultimate goal of drug therapy development and manufacturing is to deliver the highest quality product at the lowest cost and in the shortest timeframe possible," said Linda De Jesus, vice president and general manager, high performance chromatography solutions, Thermo Fisher Scientific. "With the launch and application of the HR MAM, the characterization and monitoring of biotherapeutics can be standardized across an organization – wherever their manufacturing operations are in the world – to ensure that each batch released is safe and of the highest quality."

The HR MAM provides biopharmaceutical scientists with:

  • A supported, comprehensive workflow from sample analysis to data processing, including new peak detection.
  • Method development, SOP management and product quality attribute discovery capabilities through the integration of the Thermo Scientific BioPharma Finder software with Chromeleon CDS software.
  • Flexible, 21-CFR part 11 compliant Chromeleon CDS software that supports the transition of development programs from early research to manufacturing and testing.
  • High-resolution accurate mass capabilities and quality data to accurately identify peptides and post-translational modifications and allow reliable new peak detection using the Thermo Scientific Q Exactive Plus mass spectrometer.

Do you use Thermo Fisher products in your lab? Write a review today for your chance to win a $400 Amazon gift card>>

Thermo Scientific™ Q Exactive™ GC Orbitrap™ GC-MS/MS System

Thermo Fisher Scientific

The Thermo Scientific™ Q Exactive™ GC system is the first-ever combination of high resolution gas chromatography with high-resolution/accurate-mass (HR/AM) Orbitrap detection for the most comprehensive sample characterization. This easy-to-use system provides the most comprehensive characterization of samples in a single analysis for the highest confidence in compound discovery, identification, and quantitation. Building upon the flexible modularity of the Thermo Scientific™ TRACE™ 1300 Series GC, including user-exchangeable injectors and detectors, the Q Exactive GC system has the quantitative power of a GC triple quadrupole MS combined with the high precision, full scan high-resolution/accurate-mass capability that only Orbitrap technology can offer.   Key Features: Advanced quadrupole technology (AQT) for high transmission of selected masses Resolving power up to 120,000 at m/z 200 Part-per-trillion-level sensitivity Thermo Scientific™ Extractabrite™ ion source for robust, rugged electron impact (EI) and chemical ionization (CI) performance Curved linear C-trap for precise ion injection HCD collision cell for higher energy collisional dissociation provides MS/MS ion characterization Intelligent identification software elucidates the nature of each injected sample. Applications: Untargeted and targeted metabolomics Food and beverage Industrial analyses Environmental Pharmaceutical Clinical and toxicology

(9)

Thermo Scientific™ Orbitrap Fusion™ Lumos™ Tribrid™ Mass Spectrometer

Thermo Fisher Scientific

Test new limits of detection, characterization and quantitation with the latest Tribrid™ mass spectrometer. The Thermo Scientific™ Orbitrap Fusion™ Lumos™ Tribrid™ Mass Spectrometer is designed to expand performance in advanced proteomics, biopharma and metabolomics applications, including quantitation using isobaric tags, low level PTM analysis, data independent acquisition (DIA), and top down proteomics. The new instrument features enhanced sensitivity resulting in improved analyte detection, characterization and quantitation, enabling scientists to perform more comprehensive sample analyses faster and with better accuracy than ever before.   Novel Orbitrap Fusion Lumos MS Features: Novel high-sensitivity API interface combines a High Capacity Transfer Tube and an Electrodynamic Ion Funnel for increased ion flux and lower limits of detection Advanced Active Beam Guide prevents neutrals and high velocity clusters from entering the resolving quadrupole Advanced Quadrupole Technology combines high selectivity and efficiency of transfer for selected ions symmetrically across the isolation window Advanced Vacuum Technology improves transmission of high molecular weight ions to the Orbitrap analyzer Novel ETD HD—high dynamic range ETD provides significantly increased fragment ion coverage Established Tribrid MS Features: Tribrid architecture — includes quadrupole mass filter, linear ion trap and Orbitrap mass analyzers Ultrahigh resolving power up to 500,000 FWHM, with isotopic fidelity up to 240,000 FWHM at m/z 200 Acquisition rates of up to 20 Hz for both Orbitrap and linear ion trap MSn analyses Full parallelization of MS and MSn analyses with intelligent ADAPT™ (All Dynamically Available Parallelizable Time) technology Synchronous Precursor Selection (SPS) for MS and MSn experiments significantly increases the number of peptides and proteins identified and improves quantitative accuracy when using isobaric mass tags Flexibility of fragmentation — CID, HCD and optional ETD and EThcD available at any stage of MSn with detection in either the Orbitrap or linear ion trap detector enables detailed structure determination of metabolites, glycans and other small molecules Universal Method provides maximal peptide identifications without method optimization for samples of unknown concentration, reducing sample and instrument time requirements for routine peptide identifi cation experiments Intuitive and flexible drag-and-drop user interface simplifies method development and enables unique and complex workflows

(34)

Links

Tags

New High-Resolution Mass Spectrometry-Based Workflow Simplifies Biopharmaceutical Characterization and QC