P19

NewBiologix Xcell™ Genomic Analytical Platform: a novel platform for the genomic characterization of cell lines.

R Daveau(1) M A Perrenoud(1) R Buchs(1) L Nanni(1) M Vona(1) I Bodenmann(1) P Kolcak Yasli(1) T Schuepbach(1) I Fisch(1) E Guzman(1) N Mermod(1)

1:NewBiologix SA

Cell line characterization is critical to control biological product manufacturing. Confirming the identity, purity, and genomic stability of a cell line is of upmost importance for both viral vector manufacturing and cell therapy applications. The specific strategy for characterization of a cell bank varies depending on several factors including the source of the cell line itself, cultivation history, genetic manipulation, clonality, growth requirements, amongst others.

NewBiologix Xcell™ Genomic Analytical Platform is a proprietary platform specifically designed for the genomic and transcriptomic characterization of cell lines used in gene and cell therapies, based on three specific technologies: Optical genome mapping (OGM), long-read high-fidelity (HiFi) DNA sequencing and short-read, high-throughput RNA sequencing.

OGM using Bionano help determine clonality and genomic stability over many passages. OGM can reliably estimate cell ploidy and detect complex genomic rearrangements in a single, genome-wide workflow, providing with 10,000X higher resolution compared to standard karyotyping.

Whole genome sequencing using PacBio’s HiFi long-reads technology eases the complex process of whole genome assembly and delivers highly accurate ultra-long reassembled DNA sequences, including difficult to resolve low complexity regions. HiFi reads also provide 5mC detection, allowing the analysis of the methylation status of the genome from a single sequencing experiment.

Whole-transcriptome analysis with total RNA sequencing using Illumina short-read sequencing can accurately measure gene and transcript abundance, giving information on the transcriptional capacity of the cell line.

NewBiologix Xcell™ Genomic Analytical Platform is available for characterization of cells and cell lines used in cell and gene therapy applications and in the production of biologics.