Cell banking systems

Upstream processing is deemed to commence when a single vial of the working cell bank system (see later) is taken from storage and the cells therein cultured in order to initiate the biosynthesis of a batch of product. The production process is deemed complete only when the final product is filled in its final containers and those containers have been labelled and placed in their final product packaging. 

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Figure 5.6 The master cell bank/working cell bank system. For simplicity, each bank shown above contains only five ampoules. In reality, each bank would likely consist of several hundred ampoules. Working cell bank number 2 will be generated from master cell bank vial number 2 only when working cell bank number 1 is...

There are four different drug products under Part II chemical active substance(s), radiopharmaceutical products, biological medicinal products, and vegetable medicinal products. For example, the GMP production report for biological medicinal products includes description of the genes used, strain of cell line, cell bank system, fermentation and harvesting, purification, characterization, analytical method development, process validation, impurities, and batch analysis (GMP production of biopharmaceuticals is described in Chapter 10). A DMF (Exhibit 8.8) is submitted. 

Once the cell line is selected as a host for production, a cell bank system must be generated to guarantee the availability of an adequate source of equivalent cells to use through the product s lifetime in the market. Usually, the cell bank system consists of two levels a master cell bank (MCB) and a manufacturer s working cell bank (WCB). 

NOTE For biological and biotechnological products, the following data are also required genetic development of the product, cell bank system, quality, origin and safety from viruses of the starting material, stcmdardisation of the bulk and finished product, verification of the method for viral inactivation and their validation. 

CELL BANK SYSTEM A cell bank system is a system whereby successive batches of a product are manufactured by culture in cells derived from the same master cell bank (fully characterised for identity and absence of contamination). A number of containers from the master cell bank are used to prepare a working cell bank. The cell bank system is validated for a passage level or number of population doublings beyond that achieved during routine production. 

AN4(7), AN5, AN13(6), AN14(5) cell bank, AN2(27H33), AN5(40)-(45) cell bank system, glossary... 

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