Case Studies

Avance Biosciences assessed the feasibility of a combined potency micromass assay for a cell therapy product and transferred the qualified method to its Houston facility, confirming biological response, operator precision, and site-to-site comparability.

Avance Biosciences qualified a droplet digital PCR (ddPCR)-based relative potency assay for a CRISPR-based genetic medicine, confirming specificity, accuracy, precision, and linearity across a defined potency range to support lot release and stability testing.

Avance Biosciences pre-validated and then formally validated a cell-based anti-inflammatory functional assay for a cell therapy drug product, confirming cGMP-ready specificity, accuracy, and precision across three operators and three days.

Avance Biosciences developed and compared NGS and ddPCR-based potency assay platforms for a client’s LNP gene-editing drug product, screening candidate cell lines and dose ranges to establish a reproducible, cross-validated readout method.

Avance Biosciences developed a cell-based NGS assay to characterize on- and off-target gene-editing activity for a client’s LNP drug product, comparing editing at both loci across single-dose and repeated low-dose exposure to support its nonclinical characterization program.

This case study details how Avance Biosciences validated a multi-color flow cytometry identity assay for cGMP cell therapy drug substance release, confirming specificity and precision across five surface markers. The method met predefined acceptance criteria across three analysts and multiple days under a pre-approved validation protocol.

This case study details how Avance Biosciences qualified an LC-MS/MS potency assay for a lentiviral gene therapy vector, measuring percent metabolite reduction in transduced patient-derived cells. The method met precision, assay performance, and system suitability criteria across two analysts and two days under a pre-approved cGMP protocol...

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.