amsbiowp, Author at AMSbiopharma

Hit-to-lead in drug discovery: analytical strategies for hit validation and lead optimization

Every small-molecule program begins with a deceptively simple question: Does this compound actually bind the target, and can it become a drug? Turning a screening signal into a molecule worth advancing is one of the most consequential inflection points in…

Gas chromatography-mass spectrometry (GC-MS) in drug development: pharmaceutical applications and regulatory compliance

Since the 1980s, gas chromatography has served as a stability-indicating technique for pharmaceutical products, and gas chromatography mass spectrometry (GC-MS) extended that role to trace-level identification of volatile and semi-volatile impurities that concern regulators most today, from residual solvents to…

Peptide mapping for biopharmaceutical characterization: LC-MS/MS workflows, PTM analysis, and ICH Q6B compliance

Structural complexity is one of the defining challenges of biopharmaceutical development. Unlike small-molecule drugs, large protein therapeutics (monoclonal antibodies, fusion proteins, peptide therapeutics, and biosimilars) are heterogeneous by nature, subject to a wide range of post-translational modifications that can influence…

Host cell protein detection in biologics: LC-MS/MS strategies for HCP clearance and regulatory compliance

Every biopharmaceutical produced in a living cell system carries an unavoidable burden: the proteins expressed by the host cell itself. These process-related impurities in biologics are present from the earliest stages of fermentation and must be systematically characterized, monitored, and…

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…