Journal of Bioanalysis & Biomedicine

Sylvia Van Dorpe

Publications

• Research Article
  Purity profiling of Peptide Drugs
  Author(s): Sylvia Van Dorpe, Mathieu Verbeken, Evelien Wynendaele and Bart De SpiegeleerSylvia Van Dorpe, Mathieu Verbeken, Evelien Wynendaele and Bart De Spiegeleer
  
  The quality of a peptide drug mainly depends on its impurity profile, with the emphasis on the related impurities. These impurities may be biomedically active, alter the desired efficacy or induce unwanted toxicity, an aspect which is termed the “functional quality” of the peptide drug. Therefore, regulatory authorities have set up guidances or have legally established specification limits to assure a consistent purity of these peptide drugs. For the active pharmaceutical ingredients (APIs), the pharmacopoeial monographs are legally binding. Additional information can be found in regional and international guidelines. For the finished pharmaceutical drug products (FDPs) containing peptide active ingredients, only general guidelines are available. The construction of a complete related-impurity profile is very challenging due to the wide availability of different protecting.. Read More»
  DOI: 10.4172/1948-593X.S6-003

  Abstract PDF