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Quality specifications for peptide drugs: a regulatory-pharmaceutical approach

Valentijn Vergote UGent, Christian Burvenich UGent, Christophe Van De Wiele UGent and Bart De Spiegeleer UGent (2009) Journal of Peptide Science. 15(11). p.697-710
abstract
Peptide drugs, as all types of pharmaceuticals, require adequate specifications (i.e. quality attributes, procedures and acceptance criteria) as part of their quality assurance to ensure the safety and efficacy of drug substances (i.e. active pharmaceutical ingredients) and drug products (i.e. finished pharmaceutical dosage forms). Compendial monographs are updated regularly to keep up with the most recent advances in peptide synthesis (e.g. reduced by-products) and analytical technology. Nevertheless, currently applied pharmacopoeial peptide specifications are barely harmonized yet (e.g. large differences between the European Pharmacopoeia and the United States Pharmacopeia), increasing the manufacturers’ burden of performing analytical procedures in different ways, using different acceptance criteria. Additionally, the peptide monographs are not always consistent within a single pharmacopoeia. In this review, we highlight the main differences and similarities in compendial peptide specifications (including identification, purity and assay). Based upon comparison, and together with additional information from peptide drug substance manufacturers and public evaluation reports on registration files of non-pharmacopoeial peptide drugs, a consistent monograph structure is proposed.
Please use this url to cite or link to this publication:
author
organization
year
type
journalArticle (review)
publication status
published
subject
keyword
peptide drug substance, quality attributes, acceptance criteria, regulatory affairs, ICH guidelines, Ph. Eur. and USP pharmacopoeial monographs, related substances thresholds
journal title
Journal of Peptide Science
J. pept. sci.
volume
15
issue
11
pages
697 - 710
publisher
John Wiley & Sons
Web of Science type
Review
Web of Science id
000271527700002
JCR category
CHEMISTRY, ANALYTICAL
JCR impact factor
1.807 (2009)
JCR rank
35/70 (2009)
JCR quartile
3 (2009)
ISSN
1075-2617
DOI
10.1002/psc.1167
language
English
UGent publication?
yes
classification
A1
copyright statement
I have transferred the copyright for this publication to the publisher
id
771858
handle
http://hdl.handle.net/1854/LU-771858
date created
2009-11-04 09:20:13
date last changed
2009-12-15 14:55:28
@article{771858,
  abstract     = {Peptide drugs, as all types of pharmaceuticals, require adequate specifications (i.e. quality attributes, procedures and acceptance criteria) as part of their quality assurance to ensure the safety and efficacy of drug substances (i.e. active pharmaceutical ingredients) and drug products (i.e. finished pharmaceutical dosage forms). Compendial monographs are updated regularly to keep up with the most recent advances in peptide synthesis (e.g. reduced by-products) and analytical technology. Nevertheless, currently applied pharmacopoeial peptide specifications are barely harmonized yet (e.g. large differences between the European Pharmacopoeia and the United States Pharmacopeia), increasing the manufacturers{\textquoteright} burden of performing analytical procedures in different ways, using different acceptance criteria. Additionally, the peptide monographs are not always consistent within a single pharmacopoeia. In this review, we highlight the main differences and similarities in compendial peptide specifications (including identification, purity and assay). Based upon comparison, and together with additional information from peptide drug substance manufacturers and public evaluation reports on registration files of non-pharmacopoeial peptide drugs, a consistent monograph structure is proposed.},
  author       = {Vergote, Valentijn and Burvenich, Christian and Van De Wiele, Christophe and De Spiegeleer, Bart},
  issn         = {1075-2617},
  journal      = {Journal of Peptide Science},
  keyword      = {peptide drug substance,quality attributes,acceptance criteria,regulatory affairs,ICH guidelines,Ph. Eur. and USP pharmacopoeial monographs,related substances thresholds},
  language     = {eng},
  number       = {11},
  pages        = {697--710},
  publisher    = {John Wiley \& Sons},
  title        = {Quality specifications for peptide drugs: a regulatory-pharmaceutical approach},
  url          = {http://dx.doi.org/10.1002/psc.1167},
  volume       = {15},
  year         = {2009},
}

Chicago
Vergote, Valentijn, Christian Burvenich, Christophe Van De Wiele, and Bart De Spiegeleer. 2009. “Quality Specifications for Peptide Drugs: a Regulatory-pharmaceutical Approach.” Journal of Peptide Science 15 (11): 697–710.
APA
Vergote, V., Burvenich, C., Van De Wiele, C., & De Spiegeleer, B. (2009). Quality specifications for peptide drugs: a regulatory-pharmaceutical approach. Journal of Peptide Science, 15(11), 697–710.
Vancouver
1.
Vergote V, Burvenich C, Van De Wiele C, De Spiegeleer B. Quality specifications for peptide drugs: a regulatory-pharmaceutical approach. Journal of Peptide Science. John Wiley & Sons; 2009;15(11):697–710.
MLA
Vergote, Valentijn, Christian Burvenich, Christophe Van De Wiele, et al. “Quality Specifications for Peptide Drugs: a Regulatory-pharmaceutical Approach.” Journal of Peptide Science 15.11 (2009): 697–710. Print.