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Related Concept Videos

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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Gas Chromatography–Mass Spectrometry (GC–MS)01:14

Gas Chromatography–Mass Spectrometry (GC–MS)

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Gas chromatography–mass spectrometry (GC–MS) is the combination of analytical techniques of gas chromatography and mass spectrometry in a single instrument for analyzing a mixture of compounds. The gas chromatograph separates the compounds in the mixture, and the mass spectrometer analyzes each compound separately to determine the molecular masses and molecular structures.
A gas chromatograph consists of a long, narrow capillary column with a polysiloxane coating on the inner wall....
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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 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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Inductively Coupled Plasma–Mass Spectrometry (ICP–MS): Overview01:19

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In inductively coupled plasma–mass spectrometry (ICP–MS), an inductively coupled plasma (ICP) torch is used as an atomizer and ionizer. Solid samples are dissolved and volatilized before being introduced into the high-temperature argon plasma, while solution samples are nebulized and passed through the high-temperature argon plasma. Plasma dissociates the analytes and ionizes their component atoms to form a mixture of positive ions and molecular species. The positive ions are then...
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Analyzing Large Protein Complexes by Structural Mass Spectrometry
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Advancing Mass Spectrometry Technology in cGMP Environments.

Da Ren1

  • 1Process Development, Amgen Inc., Thousand Oaks, CA 91320, USA.

Trends in Biotechnology
|July 29, 2020
PubMed
Summary

Mass spectrometry, specifically liquid chromatography-mass spectrometry (LC-MS) multi-attribute methods (MAM), is revolutionizing therapeutic protein quality control. This approach allows for comprehensive monitoring of critical quality attributes (CQAs) in cGMP settings.

Keywords:
critical quality attributes (CQAs)current good manufacturing practice (cGMP)liquid chromatography-mass spectrometry (LC-MS)multi-attribute method (MAM)quality by design (QbD)therapeutic proteins

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Area of Science:

  • Analytical Chemistry
  • Biotechnology
  • Pharmaceutical Science

Background:

  • Mass spectrometry is a key analytical technique in the biotechnology sector.
  • Ensuring the quality of therapeutic proteins is paramount for patient safety and drug efficacy.

Purpose of the Study:

  • To highlight the implementation of LC-MS based MAM in cGMP environments.
  • To demonstrate the capability of MAM for end-to-end monitoring of therapeutic protein CQAs.

Main Methods:

  • Utilizing liquid chromatography-mass spectrometry (LC-MS).
  • Implementing a multi-attribute method (MAM) for comprehensive analysis.
  • Applying the method within current Good Manufacturing Practice (cGMP) frameworks.

Main Results:

  • Successful end-to-end monitoring of critical quality attributes (CQAs) for therapeutic proteins.
  • Enhanced control over drug product quality through advanced analytical insights.

Conclusions:

  • LC-MS based MAM is a powerful tool for ensuring therapeutic protein quality.
  • The integration of MAM into cGMP processes facilitates robust drug manufacturing and quality assurance.