Arzneimittelüberwachung
Biopharmazeutika
Igetropin
Proteinanalytik
Analytik moderner Biopharmazeutika
Übersichten
Abstract
Analytics of Current Biopharmaceuticals
During the last decades, biopharmaceuticals have been established to be active and safe therapeutic drugs in numerous areas of medicine as, for example, oncology, dermatology, infectology, immunology, and in the treatment of pulmonary and cardiovascular diseases. In the near future, due to the expiration of patent protections an increasing number of biosimilars will be placed on the market. To control the quality of biopharmaceuticals sophisticated analytical methods are requested by manufacturers and competent authorities. In addition to the quality control of legally marketed medicinal products official medicines control laboratories have to analyze illegal products emerging from different sources. The article summarizes current methods in protein analysis used for the quality control of biopharmaceuticals and the investigation of suspicious samples. The results of analysis of the illicit product Igetropin containing the active ingredient Long-R3-IGF-1 are presented.
· 2Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Oberschleißheim
Korrespondenz:
Dr. Nicholas Schramek, Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Sachgebiet Pharmazie, Veterinärstr. 2, 85764 Oberschleißheim (Germany),
e-mail: nicholas.schramek@lgl.bayern.de
Key Words
Zusammenfassung
Biopharmazeutika haben sich im Laufe der vergangenen Jahrzehnte als wirksame und sichere Therapeutika in zahlreichen medizinischen Bereichen wie der Onkologie, Dermatologie, bei der Behandlung von Infektions-
