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

Bergboer, Judith GM and Kelder, Martijn JE and van Min, Max and Tuta, Nika and Crček, Mitja and Vogelsang, Matjaz (2020) Targeted Locus Amplification and NGS combined with qPCR-based breakpoint analysis for the assurance of monoclonality in recombinant cell lines. as white paper on Cergentis webpage.

Abstract

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.

Item Type: Article
Date Deposited: 29 Sep 2020 00:45
Last Modified: 29 Sep 2020 00:45
URI: https://oak.novartis.com/id/eprint/43092

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