Middle-up characterization of monoclonal antibodies by online reduction liquid chromatography-mass spectrometry

Verscheure, Liesa; Oosterlynck, Marie; Cerdobbel, An; Sandra, Patrick; Lynen, Frédéric; Sandra, Koen

doi:10.1016/j.chroma.2020.461808

Cited by 8 publications

(2 citation statements)

References 59 publications

(54 reference statements)

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“…21 Online chemical reduction has been successfully performed with the use of a trap column and DTT being introduced to the flow path to reduce the antibody. 22 Online reduction methods with the use of DTT require the reaction to be performed under basic conditions which are not hydrogen-deuterium exchange (HDX) compatible. Disulfide bond reduction has also been carried out with the use of 254 nm radiation.…”

Section: Introductionmentioning

confidence: 99%

Inline electrochemical reduction of NISTmAb for middle-up subunit liquid chromatography-mass spectrometry analysis

Morgan

Jakes

Brouwer³

et al. 2021

Analyst

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Section: Introductionmentioning

confidence: 99%

Inline electrochemical reduction of NISTmAb for middle-up subunit liquid chromatography-mass spectrometry analysis

Morgan

Jakes

Brouwer³

et al. 2021

Analyst

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“…Various techniques, such as chemical reduction, enzymatic reduction, and electrochemical reduction (ECR), can be used to accomplish this task online. Reducing biopharmaceuticals can be easily achieved through the addition of a reducing agent directly from the mobile phase reservoir (Goyon et al, 2020; Verscheure et al, 2021). This method is highly effective in detecting unstable modifications, such as succinimide intermediates, isomerization, oxidation, and deamidation, at heavy and light chains.…”

Section: Future Trendsmentioning

confidence: 99%

What is the role of current mass spectrometry in pharmaceutical analysis?

Khalikova

Jireš

Horáček

et al. 2023

Mass Spectrometry Reviews

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The role of mass spectrometry (MS) has become more important in most application domains in recent years. Pharmaceutical analysis is specific due to its stringent regulation procedures, the need for good laboratory/manufacturing practices, and a large number of routine quality control analyses to be carried out. The role of MS is, therefore, very different throughout the whole drug development cycle. While it dominates within the drug discovery and development phase, in routine quality control, the role of MS is minor and indispensable only for selected applications. Moreover, its role is very different in the case of analysis of small molecule pharmaceuticals and biopharmaceuticals. Our review explains the role of current MS in the analysis of both small‐molecule chemical drugs and biopharmaceuticals. Important features of MS‐based technologies being implemented, method requirements, and related challenges are discussed. The differences in analytical procedures for small molecule pharmaceuticals and biopharmaceuticals are pointed out. While a single method or a small set of methods is usually sufficient for quality control in the case of small molecule pharmaceuticals and MS is often not indispensable, a large panel of methods including extensive use of MS must be used for quality control of biopharmaceuticals. Finally, expected development and future trends are outlined.

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Analysis of pharmaceutically and biologically relevant protein variants

Bobály¹

2023

Liquid Chromatography

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Middle-up characterization of monoclonal antibodies by online reduction liquid chromatography-mass spectrometry

Cited by 8 publications

References 59 publications

Inline electrochemical reduction of NISTmAb for middle-up subunit liquid chromatography-mass spectrometry analysis

Inline electrochemical reduction of NISTmAb for middle-up subunit liquid chromatography-mass spectrometry analysis

What is the role of current mass spectrometry in pharmaceutical analysis?

Analysis of pharmaceutically and biologically relevant protein variants

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