Leveraging NGS to accelerate mAb development

During cell line development, gathering data on CQAs (critical quality attributes) like culture viability and product titer is crucial for gaining insights and identifying the best candidates for production. With the growing significance of monoclonal antibodies and recombinant proteins to clinicians, cell line development is more the need for cell line development laboratories to make decisions with as little ambiguity as possible when selecting cell lines is more critical than ever.

Fortunately, next-generation sequencing (NGS) can address cell line characterization and quality control requirements during cell line development through genomic sequencing of cell lines. However, preparation of NGS libraries for gene sequencing requires time-consuming and error-prone manual lab work, particularly when dealing with many cell lines at once. Automating these library preparation processes with automation instrumentation such as the Beckman Coulter Life Sciences Biomek i-Series Automated Liquid Handler can increase throughput, consistency and confidence in NGS data.

Library preparation is not the last bottleneck to NGS data - once libraries are sequenced, more work downstream is required. A key issue that arises is the management and analysis of the immense amount of data produced by NGS. Software such as Genedata Selector offers an end-to-end solution to simplify the management of data generated from NGS-based assays and facilitate data analysis and visualization, including figure generation. The data can be annotated for use in downstream omics analyses, cell culture contamination or mutation evaluations, biosafety testing, and more. The output is fully transparent and readily integrable into GMP environments to provide documentation for internal assessments, audits or submissions to regulatory authorities. The platform also enables secure data access and sharing for effective collaboration within and between project teams. Automated data analysis workflows enhance reproducibility, productivity and accuracy, helping scientists make crucial decisions earlier in the cell line development process.

The demand to shorten cell line development timelines and accelerate biotherapeutic discovery is greater than ever. At the Life Sciences companies of Danaher, we take a holistic approach to drug discovery processes and analytical methods to meet your throughput needs, automating and enhancing workflows to unlock productivity and improve quality. To learn more about our offerings or explore ways of partnering with us, contact an expert at the Life Sciences companies of Danaher today.