Case Studies

This case study explores a dual-platform potency assay strategy for multivalent LNP-mRNA vaccines, combining ELISA and flow cytometry to assess both mRNA expression and delivery performance. It highlights key analytical challenges and provides practical insights to support robust, scalable, and regulatory-ready potency testing.

To support IND-enabling studies, a biotech company needed precise measurement of in vivo gene-editing efficiency in preclinical rat tissues. Avance Biosciences delivered a fully validated NGS amplicon sequencing assay capable of detecting edits as low as 1%, enabling accurate quantification across multiple tissues and guiding data-driven development decisions.

When a gene therapy company needed to verify plasmid identity, purity, and integrity for an IND submission, Avance Biosciences delivered a validated NGS-based solution. The assay enabled low-level variant detection and trace contaminant analysis, supporting FDA compliance and lot release.