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Chemistry, Manufacturing, and Controls (CMC) in the drug development process: analytical strategies to support Investigational New Drug (IND) readiness and regulatory progression

The transition from discovery to clinical evaluation represents one of the most critical inflection points in the drug...

Analytical strategies for gene and cell therapy products: From characterization to regulatory expectations

The rapid expansion of advanced therapies has transformed how medicines are designed, manufactured, and evaluated. Unlike traditional pharmaceuticals,...

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...