Quality control testing of biopharmaceutical APIs and IMPs

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.

Quality control testing of biopharmaceutical APIs and IMPs
© 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

Contact

Nico Langer

Contact Press / Media

Dr. Nico Langer

Manager of the Working Group on Quality Control

Phone +49 531 6181-6502

Ute Pägelow

Contact Press / Media

Dr. Ute Pägelow

Phone +49 531 6181-6507