Cell Banks Preparation In Biopharmaceuticals Production

Abstract

Abstract The fast development of the biopharmaceutical market is correlated with the growing number and availability of technologies for the production of so-called biodrugs. One of the main procedures for therapeutic protein production is based on bacterial expression systems. In order to maintain the constant quality and homogeneity of the initial inoculum, the cell bank must be created in full accordance with quality standards. The first step should be the establishment of a Master Cell Bank (MCB), which must be performed in a laboratory that meets high quality standards and according to well-described main procedures. The MCB should be initiated from a single well-characterised bacterial colony. A Working Cell Bank (WCB) is usually prepared as a second step from one or few vials deposited in the MCB. The WCB must be characterised for bacterial strain homology and be free of any biological cross contamination. This paper describes the main requirements and good practises for the preparation of a cell bank suitable for constant and reproducible production of biopharmaceuticals. 1. Introduction. 2. Prokaryotic expression system. 3. Cell banking system. 4. Cell banks characterization. 4.1. Conformation of identity (properties) of the bacterial strain. 4.2. Confirmation of the purity of the bacterial strain. 5. Summary