USPUSP-NF
〈1503〉 Quality Attributes of Synthetic Peptide Drug Substances

The pharmaceutical industry’s interest in peptides as drug candidates—based on their potency, enormous functional diversity, high degree of specificity, and general lack of toxicity—has existed since their general structure was first elucidated more than 100 years ago. The early development of synthetic peptides for therapeutic use was, however, challenged by the high costs of production, their inherently short in-vivo half-lives, the lack of sensitive and discriminating analytical methods for intermediates, and the relatively complex manufacturing methods, which are now referred to as “solution peptide synthesis” or “liquid-phase peptide synthesis” (LPPS).

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