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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...

Mass Spectrometry in GMP Environments: Enhancing QC and Compliance in Drug Development

In today’s highly regulated biopharmaceutical landscape, ensuring quality, safety, and efficacy across the drug development lifecycle is both...

AMSbiopharma completes its Innovation Plan, supported by Innova Pyme, achieving progress in services, technology, and entrepreneurial culture

AMSbiopharma presented today, in an online event, the results of its Innovation Plan, developed over the past 18...

Impurity Profiling in Pharmaceuticals: Analytical Methods and Compliance

Ensuring the safety, efficacy, and quality of pharmaceutical products requires a thorough understanding of the impurities that may...

News

News

Implementation of UPLC‑MS/MS workflows in peptide therapeutics: from method development to regulatory submission

Analytical method development and stability-indicating strategies for synthetic peptide therapeutics under ICH regulatory frameworks

Preclinical Contract Research to Accelerate Drug Development: Study Design and FDA Toxicology Guidelines Considerations

Optimizing LC‑MS/MS Sensitivity: Strategies to Overcome Ion Suppression and Boost Robustness in Bioanalysis

Application of Biomarkers in Bioanalytics: Enabling Translational Development in Pharmaceutical R&D

Mass Spectrometry in GMP Environments: Enhancing QC and Compliance in Drug Development

AMSbiopharma completes its Innovation Plan, supported by Innova Pyme, achieving progress in services, technology, and entrepreneurial culture

Impurity Profiling in Pharmaceuticals: Analytical Methods and Compliance

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