<scp>LC–MS</scp>
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            <scp>MS</scp>
            Bioanalytical Method Development Strategy for Therapeutic Monoclonal Antibodies in Preclinical Studies

Li, Hongyan; Heath, Timothy D.; James, Christopher

doi:10.1002/9781119371779.ch12

Cited by 2 publications

(1 citation statement)

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“…As intact protein LC/MS methods are developed and implemented, there are many considerations for practical use of methods which take into account parameters to be optimized similar to LBAs and traditional LC/MS assays. , For example, parameters for immunocapture, general LC/MS method development, sample volume, sample handling, and assay cost may need to be considered. In addition, data processing is a key element and will be discussed in detail below.…”

Section: Points To Considermentioning

confidence: 99%

Intact Protein Mass Spectrometry for Therapeutic Protein Quantitation, Pharmacokinetics, and Biotransformation in Preclinical and Clinical Studies: An Industry Perspective

Kellie

Tran²,

Jian

et al. 2020

J. Am. Soc. Mass Spectrom.

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Recent advancements in immunocapture methods and mass spectrometer technology have enabled intact protein mass spectrometry to be applied for the characterization of antibodies and other large biotherapeutics from in-life studies. Protein molecules have not been traditionally studied by intact mass or screened for catabolites in the same manner as small molecules, but the landscape has changed. Researchers have presented methods that can be applied to the drug discovery and development stages, and others are exploring the possibilities of the new approaches. However, a wide variety of options for assay development exists without clear recommendation on best practice, and data processing workflows may have limitations depending on the vendor. In this perspective, we share experiences and recommendations for current and future application of mass spectrometry for biotherapeutic molecule monitoring from preclinical and clinical studies.

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Section: Points To Considermentioning

confidence: 99%