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Next-Generation Sequencing (NGS) has reshaped the way biologics are tested for adventitious agents—offering an agnostic, animal–free approach that accelerates timelines and improves the safety of biologics.

With the recent updates to global regulatory guidance documents endorsing its use, NGS is now well positioned to be a critical and central component of any biosafety testing strategy.

This talk, co-organized by the AFSA Collaboration and AFSA partner, PathoQuest, will provide essential details and case studies on how to implement, simplify, improve, and expand the adoption of innovative, globally accepted NGS-based biosafety solutions for your own pipelines. More importantly, this talk will provide insight into current regulatory expectations for NGS applications, specifically, what are they asking and why?

Recording of the will be made available on the AFSA website.

Agenda:

Colette Côté, Pathoquest, to present case studies (adventitious agents for human vaccines – vet). Intro, technology, regulatory stage 1 hr. Questions 30 mins

Q&A through chat function. Moderator from PQ for questions.