Control Strategies for Synthetic Therapeutic Peptide APIs

The US Pharmacopeial Convention (USP) Therapeutic Peptides Expert Panel was formed in 2013 to evaluate quality attributes for synthetic peptides based on currently available regulatory guidance and expectations. Public quality standards for drug products and drug substances are developed by USP and...

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Published in:Pharmaceutical Technology 2014-03, Vol.38 (3), p.48
Main Authors: Eggen, Ivo, Gregg, Brian, Rode, Harold, Swietlow, Aleksander, Verlander, Michael, Szajek, Anita
Format: Article
Language:English
Subjects:
Amino acids
Bioassays
Chemical bonds
Chromatography
Fourier transforms
Identification
Manufacturing
Methods
NMR
Nuclear magnetic resonance
Peptides
Pharmaceuticals
Quality standards
Regulatory approval
Series & special reports
Synthetic products
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container_issue 3
container_start_page 48
container_title Pharmaceutical Technology
container_volume 38
creator Eggen, Ivo
Gregg, Brian
Rode, Harold
Swietlow, Aleksander
Verlander, Michael
Szajek, Anita
description The US Pharmacopeial Convention (USP) Therapeutic Peptides Expert Panel was formed in 2013 to evaluate quality attributes for synthetic peptides based on currently available regulatory guidance and expectations. Public quality standards for drug products and drug substances are developed by USP and enforceable by FDA. The first article of the three-part series covers analytical characterization methods, lot release tests, and points to consider for synthetic peptide API manufacturers entering the market. Comprehensive characterization of a peptide API is required to obtain regulatory approval for marketing; the reference standard is fully characterized to ensure unequivocal identity of the material, its purity and API content. Besides evaluation of appearance, a selection of tests that fall into four categories is performed: identification, assay, purity, and specific tests.
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subjects Amino acids
Bioassays
Chemical bonds
Chromatography
Fourier transforms
Identification
Manufacturing
Methods
NMR
Nuclear magnetic resonance
Peptides
Pharmaceuticals
Quality standards
Regulatory approval
Series & special reports
Synthetic products
title Control Strategies for Synthetic Therapeutic Peptide APIs
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