ABSTRACT
Standardization and control of pharmaceutical proteins during their production is of major interest for producers and regulatory authorities [1]. Important aspects of the production of biologicals by mammalian cells for pharmaceutical applications in humans are the consistency and biological activity of the produced proteins, and the stability of the product formation and cell line during long-term culture. For this reason, these proteins should be characterized at several stages during the development and production processes of the proteins, including the establishment, standardization, and selection of the cells; adaption to culture medium; and upscaling to larger-sized culture systems. Moreover, the stability of the cells and the product during long-term culturing, for at least several months, and the product stability during downstream processing and after long term-storage have to be assessed.
