Regulatory Considerations in Synthetic Peptide Characterization: Techniques and Compliance

ABSTRACT Characterization of therapeutic peptides is a crucial step in their development, ensuring both safety and efficacy for clinical application. Given the complexity of peptide‐based drugs, regulatory agencies require a thorough understanding of their physicochemical properties, biological activity, and manufacturing processes. This paper explores the regulatory considerations essential for the characterization of therapeutic peptides, focusing on key aspects such as sequence validation, purity, structural integrity, and stability. Special attention is given to the analytical techniques required for accurate characterization, including mass spectrometry, chromatography, and spectroscopy. Regulatory guidelines, such as those set forth by the Food and Drug Administration (FDA) and European Medicines Agency (EMA), are examined in detail to ensure compliance with quality standards and to address challenges related to scalability, batch‐to‐batch consistency, and immunogenicity. By integrating these regulatory considerations into the development process, this paper emphasizes the critical role of comprehensive peptide characterization in advancing therapeutic peptides from discovery to clinical use while ensuring their safety and effectiveness in patient care.