Stabilitätsstudien mit Proteinpharmazeutika
Boehringer Ingelheim Pharma GmbH & Co KG, Biberach
Corresponding author: Dr. Jochen Wallach, Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Str. 65, 88397 Biberach (Germany), e-mail: Jochen.Wallach@boehringer-ingelheim.com
Stability Studies of Protein Pharmaceuticals
Stability studies of protein pharmaceuticals in some respect differ significantly from those performed for drugs based on small molecules. Surveillance of the heterogeneity profile as well as monitoring for possible changes in bioactivity due to fragmentation, aggregation, denaturation and side chain modifications require substantial analytical efforts throughout the product life cycle. Here, relevant protein degradation reactions and suitable analytical methods are summarized in addition to regulatory and practical aspects of stability program design. The characteristic protein degradation patterns in lyophilisates and liquid formulations are compared and the activity profile of Actilyse® is shown as an example for a protein product suitable for climatic zone III/IV.
Key words Biopharmazeutika, Degradation, Formulierung, Stablität • Proteine, Abbau
pharmind 2009, Nr. 4, Seite 687