Case Studies

5 08, 2025

Case Study: Quantifying In Vivo Gene Editing in Preclinical Tissues via NGS Amplicon-Seq
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Case Study: Quantifying In Vivo Gene Editing in Preclinical Tissues via NGS Amplicon-Seq

webmaster2025-10-22T20:51:20+00:00

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.

Case Study: Quantifying In Vivo Gene Editing in Preclinical Tissues via NGS Amplicon-Seqwebmaster2025-10-22T20:51:20+00:00

5 08, 2025

Case Study: Ensuring Plasmid Sequence Fidelity and Purity by NGS for IND-Enabling Drug Substance Release
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Case Study: Ensuring Plasmid Sequence Fidelity and Purity by NGS for IND-Enabling Drug Substance Release

webmaster2025-10-22T20:51:27+00:00

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.

Case Study: Ensuring Plasmid Sequence Fidelity and Purity by NGS for IND-Enabling Drug Substance Releasewebmaster2025-10-22T20:51:27+00:00

FDA Issues Three New Draft Guidances to Streamline Cell and Gene Therapy Development

World ADC Conference – 2025

New Technote Available – Clarifying Suitability Testing in Regulated Assays

AAPS PharmSci 360 Meeting – 2025

Sept 15-18 – BioProcess International – 2025

Avance Biosciences NGS Center of Excellence: Comprehensive Sequencing Solutions for Biologics, Gene, and Cell Therapy Development