A drug’s potency, which is a critical quality attribute, is determined by examining biological activity at the cellular level. Cell-based assays are available to measure this activity. However, selecting, developing, validating, and performing the appropriate assay demands highly-specialized expertise. This work should only be entrusted to GMP laboratories with considerable proven experience.

The purpose of this study was to develop a better model to improve the quality of ddPCR assay validation, involving how to improve the reliability of accuracy, precision, and sensitivity.

To ensure good data yield, there are challenges encountered during NGS operations, especially with poor quality RNA or DNA material, which is a common scenario for clinical samples. In this poster, we showcase three key tricks during the NGS operations to generate consistent data with high quality.