Speed to market is an important consideration for the development of lifesaving therapies, including recombinant monoclonal antibodies. However, increased speed must be balanced with quality to enable quick and efficient delivery of biopharmaceuticals to patients. Important determinants of quality include the genomic location and integrity of the transgene sequence within a recombinant cell line. Traditional methods of genetic characterization can provide incomplete information and results can be difficult to interpret. However, next-generation sequencing (NGS) approaches such as Targeted Locus Amplification (TLA) techniques are proving to be powerful tools for providing information-rich analysis of transgenes and their integration sites. In this study, we describe how Cergentis’s TLA technology allows FUJIFILM Diosynth Biotechnologies to support rapid characterization of clonal cell lines during Apollo™ X cell line development and clone selection. This includes a rapid and early confirmation of recombinant gene integrity and identification and elimination of clones that produce aberrant protein products.

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