Privatsphäre-Einstellungen

A cell bank is starting material in all fermentative production processes of drug substances. Therefore, Master Cell Bank and Working Cell Bank are of particular importance for product quality. Responsibility of the manufacturer begins already earlier than with the production of the Master Cell Bank. All operations and manipulations during development of the cell line / production strain should be completely documented. The procedures for the manufacturing of a cell bank should be planned in advance and established in a written procedure. Storage of a cell bank for the production of biological drug substances is regulated by GMP guidelines. Before using a cell bank for production a comprehensive characterization is required with proving of identity, absence of contaminations, and stability.

Key words Fermentation • Mikrobiologie • Pharmazeutische Wirkstoffe • Zellbiologie