Peptides are pivotal therapeutics that patients rely on to treat diabetes, obesity, cancer and more. Developers of these life-saving medicines face challenges interpreting regulations for biologics and small molecules that exclude peptides. USP supplies comprehensive peptide solutions including clear documentary standards with validated test methods, acceptance criteria and highly characterized API and impurity reference standards and materials. These tools help manufacturers minimize contaminants and build their control strategy. Clearly defined standards and guidance from USP help investigators and regulators save time and resources on the way to regulatory success.
NEW! Quality assessment of macrocyclic peptides
Macrocyclic peptides are an emerging class of therapeutic molecules with many of the advantages of both small and large molecule therapeutics like moderate size, high selectivity, high binding affinity, and protease stability. Made up of 5 to 14 amino acid residues (0.5 – 2.2 kDa), the principles for assessing starting materials and principles of manufacturing macrocyclic peptides are essentially the same as those for linear peptides, other than the step to form the final cyclic structure. Please refer to:
- 〈1503〉 Quality Attributes of Synthetic Peptide Drug Substances
- 〈1504〉 Quality Attributes of Starting Materials for the Chemical Synthesis of Therapeutic Peptides
Considering best practices from these chapters for identity, assay, and impurities determination provides a thorough evaluation of macrocyclic compounds, ensuring they meet the required quality standards.
