INTRODUCTION
PEPTIDE DEFINITION
MANUFACTURING METHODS
RAW MATERIALS
PEPTIDE GENERAL CHARACTERISTICS AND SPECIFICATION
Color and Appearance
Identification
Bioassays
Peptide Content and Assay
Impurities and Related Compounds
Microbiological Contamination
Bacterial Endotoxins
Specific Tests
INTRODUCTION
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).
The introduction of solid-phase peptide synthesis (SPPS) was a key factor in facilitating the expansion of peptide research and made the production of peptides with sequences longer than 20 amino acids feasible. Also, in recent years, new formulations and conjugation strategies have resulted in alternative routes of administration and longer half-lives for peptide therapeutics, which have facilitated patient compliance. As a result, more peptide drugs have been approved and are in clinical development. In spite of these successes—or perhaps because of them—some challenges in peptide manufacturing remain, especially with the increasingly complex molecules entering development.
Because synthetic peptides are not easily classified as small molecules or biological products, they are specifically excluded from many guidance documents. Hence, this chapter provides an overview of the current status and the quality attributes of synthetic therapeutic peptides, with particular emphasis on drug substance impurities and related contributing factors, including 1) manufacturing methods, 2) raw materials, 3) peptide general characteristics and specification, 4) peptide content and assay, 5) impurities and related compounds, 6) microbiological contamination, 7) bacterial endotoxins, and 8) specific tests.
Drug product quality attributes and recombinant DNA technologies, which can also be employed for manufacturing peptides for pharmaceutical use, are not included in this chapter.
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RTU(ready to use) 2ml COP vial
Polymer Vial for cell and gene therapies
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