Characterization of Impurities and Degradants in Protein Therapeutics by Mass Spectrometry

Tao, Li; Ackerman, Michael S.; Wu, Wei; Liu, Peiran; Russell, Reb J.

doi:10.1002/9780470921371.ch12

Cited by 4 publications

References 205 publications

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Process Development of Protein Therapeutics

Huang¹,

Bowes²,

Yang³

et al. 2021

Burger's Medicinal Chemistry and Drug Discovery

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The application of recombinant DNA technology to the production of protein therapeutics has undergone tremendous progress over the past decades. Considerable scientific effort has been devoted to developing robust processes that produce large amounts of complex proteins with the desired product quality attributes. An overview of the contributions from the four major disciplines working in concert to deliver these processes and methods will be covered. This article will discuss some of the tools, methods, and approaches used to produce, purify, formulate, and analyze the drugs of modern biotechnology. Future trends in each of the disciplines will also be presented.

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Process Development of Protein Therapeutics

Huang¹,

Bowes²,

Yang³

et al. 2021

Burger's Medicinal Chemistry and Drug Discovery

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Current Methods for the Characterization of Posttranslational Modifications in Therapeutic Proteins Using Orbitrap Mass Spectrometry

Hao

Hong²,

Zhang

et al. 2017

Protein Analysis Using Mass Spectrometry

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A Retrospective Evaluation of the Use of Mass Spectrometry in FDA Biologics License Applications

Rogstad

Faustino

Ruth³

et al. 2016

J. Am. Soc. Mass Spectrom.

102

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The characterization sections of biologics license applications (BLAs) approved by the United States Food and Drug Administration (FDA) between 2000 and 2015 were investigated to examine the extent of the use of mass spectrometry. Mass spectrometry was found to be integral to the characterization of these biotherapeutics. Of the 80 electronically submitted monoclonal antibody and protein biotherapeutic BLAs included in this study, 79 were found to use mass spectrometric workflows for protein or impurity characterization. To further examine how MS is being used in successful BLAs, the applications were filtered based on the type and number of quality attributes characterized, the mass spectrometric workflows used (peptide mapping, intact mass analysis, and cleaved glycan analysis), the methods used to introduce the proteins into the gas phase (ESI, MALDI, or LC-ESI), and the specific types of instrumentation used. Analyses were conducted over a time course based on the FDA BLA approval to determine if any trends in utilization could be observed over time. Additionally, the different classes of protein-based biotherapeutics among the approved BLAs were clustered to determine if any trends could be attributed to the specific type of biotherapeutic. Graphical Abstract ᅟ.

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Characterization of Impurities and Degradants in Protein Therapeutics by Mass Spectrometry

Cited by 4 publications

References 205 publications

Process Development of Protein Therapeutics

Process Development of Protein Therapeutics

Current Methods for the Characterization of Posttranslational Modifications in Therapeutic Proteins Using Orbitrap Mass Spectrometry

A Retrospective Evaluation of the Use of Mass Spectrometry in FDA Biologics License Applications

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