Overcoming Regulatory Hurdles in AAV Production

As cell and gene therapy (CGT) advances, regulatory expectations around product quality and manufacturing rigor continue to rise—especially in viral vector production. One emerging challenge is the need to demonstrate clearance of residual reagents used during upstream processing, a requirement increasingly emphasized by regulatory agencies like the FDA.

In this webinar, Miguel Dominguez and Lloyd Achirem from Mirus Bio (part of MilliporeSigma) will explore how AAV manufacturers can address this pain point through strategic partnerships and innovations. We’ll introduce a newly developed residual reagent assay tailored to Mirus Bio solutions that helps streamline regulatory submissions and supports quality assurance in viral vector workflows.

Join us to learn how the team can support your compliance strategy and hear directly from the experts driving these innovations in AAV production.