Accelerating AAV biosafety and characterization decisions with validated NGS workflows

Andrew Hillhouse

doi:10.18609/cgti.2026.096

Vollständiger Abstract

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Confirming product identity, genome integrity and freedom from adventitious agents requires a single test to hold up across genomes as small as an AAV vector and as large as a human genome, against regulatory guidance that continues to evolve (ICH Q5A(R2)). Here is how FUJIFILM Biotechnologies built validated NGS workflows covering library preparation, genome integrity, sensitivity testing and adventitious agent detection, cutting biosafety testing turnaround from up to 8 weeks to 1–2 weeks.

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Publikationsdaten

Autor:innen: Andrew Hillhouse
Quelle: Cell and Gene Therapy Insights
Publikation: 2026-01-01
Band / Ausgabe: Nicht angegeben
Seiten: Nicht angegeben
ISSN / ISBN: 2059-7800
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Zitierfähiger Nachweis

Andrew Hillhouse (2026). Accelerating AAV biosafety and characterization decisions with validated NGS workflows. Cell and Gene Therapy Insights. https://doi.org/10.18609/cgti.2026.096

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