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Multi-dimensional technology - Recent advances and applications for biotherapeutic characterization.
Bouvarel, Thomas; Camperi, Julien; Guillarme, Davy.
Afiliación
  • Bouvarel T; Protein Analytical Chemistry, Genentech, South San Francisco, California, USA.
  • Camperi J; Cell Therapy Engineering and Development, Genentech, South San Francisco, California, USA.
  • Guillarme D; Institute of Pharmaceutical Sciences of Western Switzerland, University of Geneva, Geneva, Switzerland.
J Sep Sci ; 47(5): e2300928, 2024 Mar.
Article en En | MEDLINE | ID: mdl-38471977
ABSTRACT
This review provides an overview of the latest advancements and applications in multi-dimensional liquid chromatography coupled with mass spectrometry (mD-LC-MS), covering aspects such as inter-laboratory studies, digestion strategy, trapping column, and multi-level analysis. The shift from an offline to an online workflow reduces sample processing artifacts, analytical variability, analysis time, and the labor required for data acquisition. Over the past few years, this technique has demonstrated sufficient maturity for application across a diverse range of complex products. Moreover, there is potential for this strategy to evolve into an integrated process analytical technology tool for the real-time monitoring of monoclonal antibody quality. This review also identifies emerging trends, including its application to new modalities, the possibility of evaluating biological activity within the mD-LC set-up, and the consideration of multi-dimensional capillary electrophoresis as an alternative to mD-LC. As mD-LC-MS continues to evolve and integrate emerging trends, it holds the potential to shape the next generation of analytical tools, offering exciting possibilities for enhanced characterization and monitoring of complex biopharmaceutical products.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Productos Biológicos / Anticuerpos Monoclonales Idioma: En Revista: J Sep Sci Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Alemania

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Productos Biológicos / Anticuerpos Monoclonales Idioma: En Revista: J Sep Sci Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Alemania