amsbiowp, Author at AMSbiopharma

ICH Q11 drug substance development strategies

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 consequential analytical and regulatory decisions are made with the least systematic rigor. The ICH Q11 development and manufacture of drug substances guideline,…

ICH Q8 pharmaceutical development guideline

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 paradigm toward a science- and risk-based framework centered on product and process understanding. The ICH Q8 guideline for pharmaceutical development, first published…

Peptide purification methods in drug development

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 short synthetic sequences to complex cyclic or modified peptides, every candidate entering the drug development process must meet rigorous purity thresholds before…

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 variation, and therapeutic interventions at the molecular level. Metabolomics and lipidomics have emerged as indispensable tools in this effort, offering a window…

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 in therapeutic modalities has accelerated target discovery, the path from laboratory research to approved medicine remains long and complex. In practice, advancing…

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 development process. Central to this journey is the Chemistry, Manufacturing and Controls (CMC) framework, which ensures that every dose of an investigational…

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, advanced therapy products, such as those for gene and cell therapy, function through biological mechanisms that modify cellular behavior or genetic expression,…

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 potent mutagenic impurities. Since the initial discovery of NDMA in sartan-based products in 2018, regulatory bodies have continuously refined their expectations to…

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 quality paradigm. Traditional “one-size-fits-all” approaches are increasingly inadequate for modalities like messenger RNA (mRNA), antisense oligonucleotides, and viral vectors, where the structural…

Analytical cro for outsourcing as a biotech

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 molecular complexity of new chemical entities (NCEs) and biologics increases, the traditional model of maintaining comprehensive, in-house analytical laboratories is becoming increasingly…