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Functional quality of peptide drugs

Mathieu Verbeken UGent, Nathalie Bracke UGent and Bart De Spiegeleer UGent (2012) Scientific Afternoon, Posters.
abstract
The quality of peptides might affect its functionality, and vica versa, the desired functionality determines the required quality (QbD principles). It was demonstrated that even small changes in a peptide sequence by one or two amino acids can convert a receptor agonist, respectively antagonist, into an antagonist, respectively agonist. The quality of a peptide drug mainly depends on its impurity profile, with the emphasis on related impurities, but other quality parameters may be critical as well for specific peptides, e.g. its secondary structure. These impurities may be biomedically active, altering the desired efficacy or inducing unwanted toxicity. We have recently demonstrated that synthesis impurities are responsible for the observed functional effects in a tissue model, instead of the peptide itself. Regulatory authorities have set up guidances or have legally established specification limits to assure a consistent purity of these peptide drugs once in clinical use. Nonetheless, quality control of peptides has to be a standard procedure in scientific research and early drug development to draw correct conclusions.
Please use this url to cite or link to this publication:
author
organization
year
type
conference
publication status
published
subject
keyword
Functionality, Peptides, Quality control, Development & research stage, Quality by design
in
Scientific Afternoon, Posters
conference name
4th Scientific afternoon
conference location
Ghent, Belgium
conference start
2012-05-16
conference end
2012-05-16
language
English
UGent publication?
yes
classification
C3
copyright statement
I have retained and own the full copyright for this publication
id
2109388
handle
http://hdl.handle.net/1854/LU-2109388
date created
2012-05-21 09:41:48
date last changed
2012-05-22 09:51:24
@inproceedings{2109388,
  abstract     = {The quality of peptides might affect its functionality, and vica versa, the desired functionality determines the required quality (QbD principles). It was demonstrated that even small changes in a peptide sequence by one or two amino acids can convert a receptor agonist, respectively antagonist, into an antagonist, respectively agonist. The quality of a peptide drug mainly depends on its impurity profile, with the emphasis on related impurities, but other quality parameters may be critical as well for specific peptides, e.g. its secondary structure. These impurities may be biomedically active, altering the desired efficacy or inducing unwanted toxicity. We have recently demonstrated that synthesis impurities are responsible for the observed functional effects in a tissue model, instead of the peptide itself. Regulatory authorities have set up guidances or have legally established specification limits to assure a consistent purity of these peptide drugs once in clinical use. Nonetheless, quality control of peptides has to be a standard procedure in scientific research and early drug development to draw correct conclusions.},
  author       = {Verbeken, Mathieu and Bracke, Nathalie and De Spiegeleer, Bart},
  booktitle    = {Scientific Afternoon, Posters},
  keyword      = {Functionality,Peptides,Quality control,Development \& research stage,Quality by design},
  language     = {eng},
  location     = {Ghent, Belgium},
  title        = {Functional quality of peptide drugs},
  year         = {2012},
}

Chicago
Verbeken, Mathieu, Nathalie Bracke, and Bart De Spiegeleer. 2012. “Functional Quality of Peptide Drugs.” In Scientific Afternoon, Posters.
APA
Verbeken, M., Bracke, N., & De Spiegeleer, B. (2012). Functional quality of peptide drugs. Scientific Afternoon, Posters. Presented at the 4th Scientific afternoon.
Vancouver
1.
Verbeken M, Bracke N, De Spiegeleer B. Functional quality of peptide drugs. Scientific Afternoon, Posters. 2012.
MLA
Verbeken, Mathieu, Nathalie Bracke, and Bart De Spiegeleer. “Functional Quality of Peptide Drugs.” Scientific Afternoon, Posters. 2012. Print.