Using NGS to Characterize Cell Lines Used for Production of Biologics: Verifying Clonality and Identity

Regulatory authorities require a high level of confirmation of the characteristics of a cell line including its provenience and clonality to ensure safety, reproducibility, and product efficacy. Full genome characterization of your cell line provides support for its identity and clonality and ensures you and your team are on the right path.

The utilization of next generation sequencing (NGS) to identify the presence, absence, or prevalence of SNPs enables identification of possible differing strains and lineages within the cell line. Identifying the integration sequence, the precise sequence of the plasmid fragment integrated into the cell line, and rearrangements or copies via deep sequencing can provide strong documentation for clonality and validation with respect to the product quality during manufacturing and as an “end-of-process control” for batch release.

View the webinar replay to learn about the use of the latest sequencing technologies for the characterization of your cell lines.

Presenters

  • Nicole Borth, PhD, Professor of Cell Biology and Cytometry, University of Natural Resources and Life Science (BOKU) & Area Leader, Austrian Center of Industrial Biotechnology (ACIB)
  • Stéphane Cruveiller, PhD, Chief Technology Information Officer, PathoQuest