International Journal of Pharmaceutics
Volume 518, Issues 12,25 February 2017, Pages 320-334
Building parity between brand and generic peptide products: Regulatory and scientific considerations for quality of synthetic peptides
Peptides are a fast growing segment in the pharmaceutical industry. Consequently,杭州妃子阁 the industry and regulatory agencies are increasing their focus on the regulatory path and quality considerations for peptide development and manufacturing. Although most peptides are synthetic, manufactured by solid phase synthesis, nevertheless they are complex molecules with challenging quality and regulatory aspects. This paper provides a structured overview of relevant quality issues for chemically synthesized peptides used as active pharmaceutical ingredients (API) in drug products. It addresses the unique characteristics of peptides pertaining to structural and physicochemical characterization, manufacturing and in process controls, impurities and aggregates arising from manufacturing and storage, along with their potential impact on safety (including immunogenicity) and efficacy of the peptide drug products.