Have we finally reached the end of in vitro testing? Positioning NGS in cell and gene therapy biosafety testing

Tuesday 08:00 PDT / 11:00 EDT / 16:00 BST / 17:00 CEST

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Have we finally reached the end of in vitro testing? Positioning NGS in cell and gene therapy biosafety testing

Attend this webinar for data-driven insights on how transcriptome-based next generation sequencing (NGS) can deliver broader detection, higher sensitivity, and faster timelines for viral safety testing, while reducing reliance on animal-based and in vitro methods.

With recent regulatory updates, NGS is now positioned as a viable replacement for traditional PCR-based and animal-derived approaches, enabling detection of the full 9 CFR panel of bovine and porcine viruses, all 19 rodent viruses under ICH Q5A (R2), 13 human and simian viruses requested by regulatory agencies, as well as other known and novel viruses.

Attendees will learn how to simplify complex biosafety strategies, strengthen confidence in viral detection, and align testing frameworks with evolving regulatory expectations.

Attend this webinar to:

Understand how iDTECT® Transcriptome-based NGS can serve as a single alternative to multiple legacy viral safety assays, including panel-based HAP/MAP/RAP, PCR, and 9 CFR tests
Review data from a joint study by PathoQuest and Charles River Laboratories validating detection of required, known, and novel viruses
Identify opportunities to consolidate viral safety workflows and strengthen regulatory discussions through risk-based assessment

Register now to gain practical insight into positioning NGS within modern viral safety strategies in CGT manufacturing workflows.

Colette Côté, PhD

Chief Scientific and Portfolio Officer & US General Manager at PathoQuest

Colette Côté joined PathoQuest as US General Manager and Chief Scientific and Portfolio Officer in March 2021. Prior to joining PathoQuest, Colette was the Director and Head of NGS R&D Testing Services at MilliporeSigma. Over the past 17 years, Colette has used her expertise and long history of innovating, developing, and applying tailored NGS-based assays to the biosafety testing space with a goal to expand and grow NGS far beyond its early applications, with a view towards the future.

In 53 Days

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