GEN-MKT-18-7897-A
Feb 29, 2016 | Biopharma, Blogs | 0 comments
Traditionally, the pharmacokinetic profile of biotherapeutics such as insulin glargine, adalimumab, trastuzumab and others, used gold standard LBAs to assess dose-response during drug discovery and development. However, LBAs require a specific antibody reagent to be developed for each mAb variant, a process that is often incompatible with the compressed timeframes encountered during the initial stages of drug development. More recently, LC-MS/MS-based methods have come to the forefront as a feasible approach for the quantification of biotherapeutics in biological matrices, with many of these methods relying on proteolytic digestion of the target mAb and quantification of multiple unique signature peptides, which are equivalent to levels of the whole protein. But, to drive the real biological need, we have to quantify the pharmacologically active or free form of the drug to assess safety, efficacy and proper dosing regimen. Here we present a solution to get the best of both technologies: an LBA strategy to capture the active form of the drug; and an LC-MS assay to selectively quantify the free and circulating drug.
It is no secret that (bio)pharmaceutical research and development is complex, both scientific and regulatory processes. Here is an overview of just some of the ways SCIEX is working to support these challenges.
In a recent webinar, available on demand, scientists Luiza Chrojan and Ryan Hylands from Pharmaron, provided insights into the deployment of capillary gel electrophoresis (CGE) within cell and gene therapy. Luiza and Ryan shared purity data on plasmids used for adeno-associated virus (AAV) manufacturing and data on AAV genome integrity, viral protein (VP) purity and VP ratios using the BioPhase 8800 system.
Last year, Technology Networks hosted two webinars that featured groundbreaking research utilizing SWATH DIA (data-independent acquisition) for exposomics and metabolomics. Researchers Dr. Vinicius Verri Hernandes from the University of Vienna and Dr. Cristina Balcells from Imperial College London (ICL) demonstrated how a DIA approach can be successfully implemented in small molecule analysis using the ZenoTOF 7600 system. Their innovative approaches highlight the potential of SWATH DIA to enhance the detection and analysis of chemical exposures and metabolites, paving the way for new insights into environmental health and disease mechanisms.
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