Peptide Characterization

Introduction The implementation of ICH Q7 for Peptide APIs establishes the essential regulatory framework and Good Manufacturing Practice (GMP) requirements […]

Introduction Justifying Regulatory Starting Materials for Synthetic Peptides under the International Council for Harmonisation (ICH) Q11 guideline requires a robust

Introduction Establishing rigorous quality attributes for Amino Acid Derivatives and Building Blocks is one of the most critical factors in

Introduction The evolution of therapeutic peptides from research reagents to approved drugs over the past 50 years represents a major

Introduction Understanding the peptide characterization timeline is essential for pharmaceutical companies preparing an Investigational New Drug (IND) application or an

Introduction: Synthetic Peptide Impurity Analysis is the process of detecting, characterizing and controlling structurally similar impurities that remain after peptide

Introduction: Peptide Identity and Purity Testing is essential for determining whether a compounded or research-grade peptide is the correct molecule

Introduction: Immunogenicity Risk Assessment of Peptide Impurities is a key part of pharmaceutical development whenever an unexpected impurity appears in

Introduction: Peptide Synthesis vs Protein Manufacturing is an important distinction in pharmaceutical development, biotechnology, and analytical science, and the two

Introduction Peptide Analytical Method Development and Validation is a critical component of peptide drug development because peptide molecules present analytical