ICH Q11 development and manufacture of drug substances: analytical and process strategies for robust CMC principles implementation
Drug substance development sits at the foundation of every pharmaceutical program, yet it is often where the most...
ICH Q8 guideline for pharmaceutical development: analytical strategies for quality by design in complex drug modalities
Regulatory expectations for pharmaceutical development have evolved considerably over the past two decades, from a compliance-driven and empirical...
Peptide purification in drug development: methods, techniques, and analytical strategies
The growing pipeline of peptide-based therapeutics has placed peptide purification at the center of pharmaceutical manufacturing strategy. From...
Metabolomics and lipidomics in drug discovery and development: analytical approaches for biomarker discovery and preclinical research
The search for safer, more effective medicines increasingly depends on understanding how biological systems respond to disease, genetic...
Drug development timeline: how early characterization prevents regulatory delays
The modern drug development timeline is highly shaped by manufacturing readiness, analytical understanding, and regulatory alignment. While innovation...
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...