Recombinant protein therapeutics are routinely produced in Chinese hamster ovary (CHO) cells. Minimizing the heterogeneity within a Master Cell Bank (MCB) allows for a well-controlled process that is capable of the consistent manufacture of a product. Regulatory authorities therefore expect that clonal CHO cell lines are used. In this paper, we describe a rapid, reliable and cost-effective assessment of the probability of clonal derivation of recombinant cell populations by combining TLA and NGS with MCB-specific breakpoint qPCR assays and statistical analyses.

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