Glossary of pharmaceutical and GMP terms with explanations

In this section of GMP-inspection.com, our translators provide definitions and explanations of various specialized terms from the pharmaceutical industry and GMP (Good Manufacturing Practice).

Cell bank

The cells in a cell bank may be of various types, including but not limited to bacterial, animal, human or insect cells.

In the context of the pharmaceutical industry and biotechnology, a cell bank (German translation: Zellbank) refers to a systematic collection of cells that are stored for later use in research, drug development, or for the manufacture of biologics such as vaccines or monoclonal antibodies (German: monoklonale Antikörper).

The cells in such a cell bank may be of various types, including but not limited to bacterial, animal, human or insect cells. They can be used as a production platform for the manufacture of biologically active substances or for scientific research.

Characteristics of a cell bank:

  • Storage and preservation: Cells are usually stored at very low temperatures (e.g. in liquid nitrogen) in order to maintain their viability over long periods of time.
  • Standardization and quality control: The cells must be carefully identified, classified and checked for contamination. This ensures their suitability for use in research and production.
  • Master and working cell bank: The master cell bank (MCB; translation into German: Masterzellbank) serves as the basis for biotechnological production, as the working cell bank (WCB; German: Arbeitszellbank), from which the cells required for production are taken, is cultivated from it. This system ensures that the same cell substrate of the validated cell line is always available.

Cell banks are of central importance for the development and manufacture of biotechnological drugs. Cell banks are subject to certain legal regulations such as the German Genetic Engineering Act, which requires, among other things, a risk assessment in the event of the unintentional release of cells.

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