EMA’s updated nitrosamines guideline: Implications for acceptable intake limits and analytical strategies
The landscape of impurity control in pharmaceutical manufacturing has been profoundly reshaped by the emergence of N-nitrosamines as...
Designing “fit-for-purpose” quality control protocols for biologics and nucleic acid therapeutics
The rapid maturation of nucleic acid therapeutics and complex biologics has necessitated a significant shift in the pharmaceutical...
Outsourcing as a biotech: How analytical CROs drive efficiency, compliance, and speed in drug development
The landscape of drug discovery and development has undergone a tectonic shift over the last decade. As the...
Implementation of UPLC‑MS/MS workflows in peptide therapeutics: from method development to regulatory submission
Peptide therapeutics represent a rapidly growing segment of pharmaceutical pipelines, offering high specificity and potency. However, their bioanalysis...
Analytical method development and stability-indicating strategies for synthetic peptide therapeutics under ICH regulatory frameworks
The pharmaceutical landscape is increasingly dominated by peptide therapeutics, which offer higher specificity and efficacy than small molecules....
Preclinical Contract Research to Accelerate Drug Development: Study Design and FDA Toxicology Guidelines Considerations
Before a drug candidate reaches clinical testing, it must demonstrate safety and efficacy under controlled laboratory conditions. This...
Optimizing LC‑MS/MS Sensitivity: Strategies to Overcome Ion Suppression and Boost Robustness in Bioanalysis
Liquid chromatography coupled with tandem mass spectrometry (LC‑MS/MS) has become the reference technique for quantitative bioanalysis in drug...
Application of Biomarkers in Bioanalytics: Enabling Translational Development in Pharmaceutical R&D
In bioanalytical workflows, biomarkers serve as quantifiable proxies for biological processes, disease states, or therapeutic responses. Still, the...