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Related Concept Videos

Tandem Mass Spectrometry01:21

Tandem Mass Spectrometry

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Tandem mass spectrometry is a technique that uses multiple mass analyzers in series to obtain a higher selectivity and reduce chemical noise during analyte detection. Instruments with multiple analyzers separated by an interaction cell enable secondary fragmentation and selected study of the fragment ions.Secondary fragmentations occur in the interaction cell and can be induced by various factors. Fragmentation induced by collision with inert gases, such as N2, Ar, He, etc., is called...
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MALDI-TOF Mass Spectrometry01:19

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Mass spectrometry is a powerful characterization technique that can identify and separate a wide variety of compounds ranging from chemical to biological entities, based on their mass-to-charge ratio (m/z). The instruments that allow this detection, known as mass spectrometers, have three components: an ion source, a mass analyzer, and a detector. These spectrometers differ based on the nature of their ion source and analyzers.Matrix-assisted laser desorption ionization (MALDI) is a commonly...
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Mass Spectrometry: Complex Analysis01:21

Mass Spectrometry: Complex Analysis

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Mass spectrometry is an important technique for the identification of pure compounds. However, it has some limitations for the analysis of complex mixtures, often due to excessive fragmentation making the spectrum too complicated to decipher. Mass spectrometry can be combined with suitable separation methods in sequence, forming hyphenated methods, which are useful in the analysis of complex mixtures.
GC–MS is a powerful hyphenated method commonly used in forensics and environmental...
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Mass Spectrometers01:16

Mass Spectrometers

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This lesson details the instrumentation of a mass spectrometer—a physical instrument to perform mass spectrometry on analyte molecules and record the characteristic mass spectra. This is achieved via three chief functions:
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Peptide Identification Using Tandem Mass Spectrometry01:33

Peptide Identification Using Tandem Mass Spectrometry

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Tandem mass spectrometry, also known as MS/MS or MS2, is an analytical technique that employs two mass analyzers. Essentially it is a series of mass spectrometers that helps isolate a particular biomolecule and then helps study its chemical properties.
This technique helps gather information regarding the protein from which the peptide was obtained and to study the peptides’ amino acid sequence. Identifying peptides from a complex mixture is an important component of the growing field of...
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Mass Spectrometry: Overview01:19

Mass Spectrometry: Overview

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Mass spectrometry is an analytical technique used to determine the molecular mass and molecular formula of a compound. The basic principle of mass spectrometry is to generate ions from the analyte molecule and measure these ion abundances against their molecular mass. One common type of ionization, known as electron ionization or EI, bombards the analyte molecules in the gas phase with high-energy electron beams. The electron beams displace an electron from the molecule and leave behind a...
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Related Experiment Video

Updated: Mar 12, 2026

Large Scale Non-targeted Metabolomic Profiling of Serum by Ultra Performance Liquid Chromatography-Mass Spectrometry UPLC-MS
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Using mass spectrometry for robust identity release testing in a global quality control network.

Sebastien Leibe1, Sebastien Violini1, Moritz Vollrath1

  • 1Pharma Technical Development Analytics, F. Hoffmann-La Roche, Basel, Switzerland.

Mabs
|March 10, 2026
PubMed
Summary
This summary is machine-generated.

Roche/Genentech developed a mass spectrometry-based method for biologics product identity testing. This robust, automated platform enhances quality control, reduces errors, and allows detailed analysis of product variants.

Keywords:
Mass spectrometryautomationbiologicscritical quality attributesidentity testingmulti attribute monitoringonline HPLCquality control

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Area of Science:

  • Pharmaceutical Quality Control
  • Analytical Chemistry
  • Biotechnology

Background:

  • Product identity (ID) testing is critical for pharmaceutical quality control.
  • Existing methods may require extensive validation and are prone to errors.
  • Biologics require rigorous testing to ensure safety and efficacy.

Purpose of the Study:

  • To establish a mass spectrometry-based platform ID method for routine release testing of biologics.
  • To develop an automated and user-friendly method for quality control environments.
  • To enhance the evaluation of product variants and support root cause analysis.

Main Methods:

  • Peptide mapping combined with liquid chromatography-mass spectrometry (LC-MS).
  • Automated data evaluation for routine release testing.
  • Application in global clinical and commercial quality control settings.

Main Results:

  • The LC-MS peptide mapping method is robust and user-friendly.
  • Significantly reduced validation work for new biologic products.
  • Lowered error rates in test execution and data evaluation.
  • Sensitive, high-resolution evaluation of chemical and post-translational modifications.

Conclusions:

  • The established mass spectrometry platform enables improved product monitoring.
  • Data from ID testing can be re-evaluated for quality impact assessments.
  • This technology streamlines root cause analysis and failure mitigation.
  • Qualified across all Roche/Genentech quality control sites for enhanced biologic monitoring.