Quality control testing of biopharmaceutical APIs and IMPs

© Fraunhofer ITEM

The quality of medicinal products and active (bio-)pharmaceutical ingredients (APIs) must be tested and documented according to the requirements of the  German Drug Act. According to the German Drug Act, quality is the nature of a drug "as determined by its identity, content, purity and other chemical, physical and biological properties or by the manufacturing process“. Quality control testing of intermediates and final products is performed according to written instructions and validated test procedures, in order to demonstrate compliance with predetermined specifications.

© Fraunhofer ITEM

Methods

Physicochemical methods of analysis, e.g. conductivity, TOC 

Chemical analyses, e.g. nitrate, heavy metals 

Bioanalytical methods, such as microbiological analyses, mycoplasma test, PCR, ELISA, plasmon interference/BIACORE

Electrophoretic techniques: CE/CZE, IEF, SDS-PAGE 

ELISA/PCR: host cell protein (HCP), endotoxins, DNA 

Analytical HPLC: IEC, SEC, RP 

UV spectrometry