GEN-MKT-18-7897-A
Aug 16, 2024 | Blogs, Pharma, QTRAP / Triple Quad | 0 comments
Read time: 2 minutes
Meeting deadlines in a bioanalysis laboratory can be a big challenge. Older, less sensitive and less reliable LC-MS systems make it even more difficult. Even the disruption caused by the installation and validation can be disconcerting and delay decisions. Does this sound familiar?
Let’s break down the process and potential benefits of a regulated laboratory. The biggest challenge is usually the software installation and validation. To streamline this step, the Change Control support plan from SCIEX helps customers who require revalidation of their software to mitigate risk for software and hardware system assessments. Collaborate with us to integrate new software features seamlessly, bolster system security, enhance performance and ensure compatibility.
High system robustness enables analysis of large-scale sample sets
Learn how the robustness of the QTRAP 6500+ system ensures a smooth analysis of gut metabolites in plasma even with a high number of samples, complex matrices and challenging excipients.
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Highly sensitive LC-MS/MS method for the quantification of fluticasone propionate in human plasma
Fluticasone propionate, a synthetic glucocorticoid with potent anti-inflammatory activity, requires very sensitive assays to monitor pharmacokinetic parameters due to the very low therapeutic inhaled dose ranges. This need has led us to use large sample volumes. Here, a selective, sensitive and reproducible bioanalytical method was developed for quantitation of fluticasone propionate (LLOQ of 200 fg/mL) in human plasma using the QTRAP 6500 system. Reduced sample volume (500 µL plasma) and a final reconstitution volume of 200 µL for reinjection of samples or repeat analysis chromatography if required in a GLP laboratory.
SCIEX OS software allows you to upgrade to a dry roughing pump configuration, you can expand your productivity and save money at the same time.
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As an analytical strategy, middle-down mass spectrometry (MS) workflows characterize biotherapeutic proteins by analyzing large, digested protein fragments or defined subunits, rather than fully intact proteins (top-down) or digested peptides (bottom-up). A middle-down strategy combines the strengths of top-down and bottom-up approaches by delivering high sequence coverage and structural specificity while maintaining relatively simple sample preparation. In practice, middle-down analysis enables accurate mass measurement, rapid sequence confirmation, and localization of key post-translational modifications (PTMs) on protein subunits that are directly relevant to product quality.
In biopharmaceutical development, sequence variants (SV) are considered an inherent risk of producing complex proteins in living systems. Sequence variants are unintended changes to the amino acid sequence of a biotherapeutic and can be caused by errors in transcription or translation in the host cell, or cell culture and process conditions. Detailed analysis of SVs is important in process and product development to ensure the drug’s safety and efficacy. Even low‑level sequence variants can have significant implications for product quality, safety, and efficacy, making their accurate detection and characterization a critical requirement across development, process optimization, and regulatory submission.
CE‑SDS remains a cornerstone assay for characterizing fragmentation, aggregation, and product‑related impurities in therapeutic proteins. UV detection has been the long‑standing standard. However, it frequently struggles with baseline noise, limited sensitivity for minor fragments, and subjective integration.
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