TLA and NGS combined with qPCR-based breakpoint analysis for the assurance of monoclonality in recombinant cell lines

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, Novartis and Cergentis 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.

White Paper - Novartis Monoclonality Assurance