A Unified NGS‑MAM Framework for Comprehensive Vector Characterization

April 16, 2026

Cell and gene therapies (CGTs) advance rapidly, offering new treatments for previously incurable diseases. Such therapeutics are highly sensitive to genetic and phenotypic changes, thus control of Critical Quality Attributes (CQAs) related to identity, potency, and safety throughout development is essential. Viral vectors, such as Lentivirus (LV) or Adeno‑Associated Virus (AAV), are critical components of these therapies and require precise CQA characterization. Traditional methods to do so are costly, time‑consuming, and resource‑intensive. Next‑generation sequencing (NGS) stands out as the most accurate and comprehensive method for assessing numerous CQAs, as it supports high‑resolution characterization from minimal input material. However, implementing NGS‑based assays for CQA monitoring remains challenging, due to the complexity of the data generated and the need to validate each assay individually.

Genedata Selector^® is a validation‑ready platform for NGS data analysis, that addresses these challenges. By streamlining bioinformatics NGS workflows in-house, it unlocks the Multi‑Attribute Method (MAM) approach for NGS. This enables simultaneous detection, analysis, and monitoring of multiple CQAs within a single sample, ultimately streamlining testing, reducing costs, and accelerating the availability of life‑saving treatments.