As the gene and cell therapy market continues to expand, affordability and accelerated turnaround time (TAT) become increasingly important in the industry. Despite the escalating diversity of therapeutic modalities, the criticality of a robust cell bank remains a pivotal starting point for many biological products. The integrity of species identity for cell lines is a critical quality attribute for many cell and gene therapies, and with regulatory agencies expecting strong data confirming such, WuXi Advanced Therapies (ATU) has recently automated its Cell Line Identity Assay using a new integrated sequencing platform. In this presentation, WuXi Advanced Therapies will showcase how to enhance the quality and efficiency of cell line species identity confirmation through custom designed primers targeting species-specific sequences within protein-coding genes located on nuclear chromosomes and mitochondrial DNA. Together with the use of automation in the Next-Generation Sequencing (NGS) workflow, variability is reduced while precision and throughput are increased to ultimately accelerate customerâ€™s pipeline to market.
- The Cell Line Identity assay is a robust species-level identity method
- Demonstrate species specificity and internal controls for assay validity
- Automation enhances the performance and quality of release assays
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