Master cell bank , large

LSBL MAP MCB NDA NIH PPC PTC QA QC RAP WCB WCP WHO large-scale biosafety level mouse antibody production master cell bank new drug application National Institutes of Health post-production cells points to consider quality assurance quality control rat antibody production working cell bank well-characterized product World Health Organization... 

Preclinical development comprises the technical and scientific elaboration of a process to manufacture the desired product on a large scale. Firstly, cell cultures and microorganisms to be used must be established as Master Cell Banks and Working Cell Banks, or as Master and Working Seeds, respectively. These ensure... 

To guarantee the availability of cells and the maintenance of their characteristics, a sufficiently large quantity of cells is kept in master and working cell banks, as discussed in Chapters 13 and 14. The number of cryotubes containing cells in a working cell bank is calculated to ensure that, for the whole expected lifespan of a product, each production lot will be obtained starting with cells from identical cryotubes. The most widely employed method for the conservation of cell banks is cryoconservation in liquid nitrogen at -196°C, which avoids mutations that could potentially alter cell characteristics. 

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