Intact Protein Mass Spectrometry for Therapeutic Protein Quantitation, Pharmacokinetics, and Biotransformation in Preclinical and Clinical Studies: An Industry Perspective
| Autor: | Ying Ge, Kevin P. Bateman, Jack Henion, Barry R Jones, John C. Tran, John T Mehl, John F. Kellie, Wenying Jian |
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| Rok vydání: | 2020 |
| Předmět: |
Immunoconjugates
Drug Evaluation Preclinical Computational biology 010402 general chemistry Mass spectrometry 01 natural sciences Chromatography Affinity Mass Spectrometry Specimen Handling Pharmacokinetics Biotransformation Structural Biology Animals Humans Spectroscopy Protein molecules Drug discovery Chemistry 010401 analytical chemistry Therapeutic protein Intact protein Proteins Small molecule 0104 chemical sciences Chromatography Liquid |
| Zdroj: | Journal of the American Society for Mass Spectrometry. 32(8) |
| ISSN: | 1879-1123 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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