Copyright (c) 1996 Elsevier Science B.V. All rights reserved.
Neither peptides nor proteins may be considered as « conventional » drugs or conventional active agents due to their complexity.
Therefore, several guidelines and rules concerning quality control of proteins and peptides have been published by different regulatory authorities recently.
Whereas a detailed guideline exists for synthetic peptides, such rules are not yet available for biotechnologically produced proteins.
In this article the general regulatory requirements for the quality control of peptides and proteins are compared, illustrated by the existing monographs in the European Pharmacopoeia.
Suggestions are made to review the quality control and specification limits for impurities in peptides and proteins as active substances are proposed.
Mots-clés Pascal : Peptide, Protéine, Macromolécule biologique, Produit synthétique, Synthèse chimique, Biotechnologie, Législation, Médicament, Recommandation, Réglementation, Contrôle qualité, Pharmacopée, Europe, Pureté, Protéine recombinante, Article synthèse
Mots-clés Pascal anglais : Peptides, Proteins, Biological macromolecule, Synthetic product, Chemical synthesis, Biotechnology, Legislation, Drug, Recommendation, Regulation, Quality control, Pharmacopeia, Europe, Purity, Recombinant protein, Review
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 97-0078734
Code Inist : 002B30A08. Création : 21/05/1997.