Consistent production of genetically stable mammalian cell lines

BioPharm International, 05/07/2012

Genetic and expression stability are important metrics that should be used to evaluate any cell line development method. A cell line that is genetically stable throughout the biopharmaceutical manufacturing process is essential for any development program and is required for regulatory adherence. The definition of genetic stability can vary slightly depending on application; however, typically, genetic stability is confirmation that the transgene DNA and subsequent mRNA sequence along with the number of transgene copies do not change over the length of time required to perform a biopharmaceutical manufacturing run.

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