Liquid Chromatography-High-Resolution Mass Spectrometry for Regulated Bioanalysis: Bile Acid and Oligonucleotide Quantitation as A Reference

Mei, Meng

doi:10.4155/bio-2016-0268

Cited by 4 publications

(1 citation statement)

References 9 publications

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“…As the key steps in sample processing/analysis are immunocapture and HRMS, the impact of these steps on best practices may be a good starting point for such a dialogue. There are already a number of discussions on record on the use of immunocapture for LC/MS bioanalysis, and there are examples of HRMS for GxP, in particular for oligonucleotides. − However, some aspects of data processing have not been discussed in GxP context. For example, selection of multiple charge states, deconvolution, or relative quantitation practices may be justifiable in certain instances but not others.…”

Section: Data Processing Intrepretation and Reportingmentioning

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: Data Processing Intrepretation and Reportingmentioning

confidence: 99%