SCIEX

Articles by SCIEX

Throughout drug development, it is important to characterize and quantify pharmaceutical compounds and any associated metabolites to ensure proper drug safety and efficacy. LC-MS/MS techniques are predominantly used for such analyses because they provide a comprehensive outlook and can offer a sensitive and selective approach for the quantification of compounds. However, limited deep fragment coverage and sensitivity challenge the confident identification and quantification of metabolites and drug products. Here, alternative fragmentation paired with a highly sensitive QTOF system was employed for comprehensive data collection to properly identify metabolites and quantify complex peptide therapeutics.

• The identification of drug metabolites is a critical step in drug development due to their impact on drug efficacy and safety. LC-MS platforms provide good selectivity and sensitivity making it the preferred technique for metabolite identification. Here, metabolite identification was performed using unique fragments from EAD and CID spectra. Fragment information from EAD and CID spectra were processed in a single result file to achieve confident structure assignment of and localization of metabolites.

Nitrosamine contamination in pharmaceuticals has become a major regulatory concern due to their potent carcinogenicity, requiring ultra-trace-level detection to ensure patient safety. Advanced LC-MS/MS workflows provide the necessary sensitivity, selectivity, and robustness to accurately quantify nitrosamine drug substance-related impurities (NDSRIs), even within complex pharmaceutical matrices. Case studies with betahistine, orphenadrine, and chloropyramine demonstrate how streamlined LC-MS/MS strategies can reliably detect and confirm nitrosamine impurities well below regulatory thresholds.

We understand you are busy, needing to prioritize running instruments, reporting results and managing your laboratory to meet deadlines. We created this solution guide to explain how SCIEX systems fit in the drug development pipeline to save you time evaluating options. This guide covers bio/pharmaceutical quantitative assays from discovery to QA/QC, for large and small molecules. Happy reading!

The dream state If we lived in an ideal world, it would be possible to unambiguously identify metabolites using a single analytical experiment. This analytical technique would need to be efficient and easily generate the information needed from a routine assay that is also robust, enabling confident decision-making during drug discovery. At SCIEX, we believe that metabolite identification using the ZenoTOF 7600 system gets close to this dream state.

Glycan analysis provides key information on critical quality attributes that could affect stability, safety and efficacy of a protein therapeutic. Specific needs for understanding the glycosylation profiles change throughout the drug development process, but the requirement for high-resolution glycan information remains the same and is essential to help ensure product quality.

Charge heterogeneity is present in most biopharmaceutical protein products. During the manufacturing process, charge heterogeneity of the protein therapeutics can occur due to enzymatic cleavage and chemical post-translational modifications (PTM). For therapeutics like ADCs, not only the antibody contributes to the heterogeneity but also the linker and payload, which add even more complexity to the charge variant profiles. Characterizing the charge heterogeneity of ADCs is essential for critical quality attribute (CQA) assessment to ensure drug safety, efficacy, and potency.