In this free webinar, understand the regulatory landscape and quality expectations for viral vector manufacturing in CGT. Attendees will learn why residual reagent clearance is critical for FDA compliance. The featured speakers will share solutions for AAV workflows and how to overcome associated regulatory challenges. Attendees will see how assay services can simplify regulatory submissions.
TORONTO, Oct. 7, 2025 /PRNewswire/ -- As cell and gene therapy (CGT) advances, regulatory expectations around product quality and manufacturing rigor continue to rise, especially in viral vector production, such as AAV 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, the featured speakers will explore how AAV manufacturers can address this pain point through strategic partnerships and innovations. They'll introduce a newly developed residual reagent assay designed for use in AAV production workflows. This type of assay helps streamline regulatory submissions and supports quality assurance in viral vector workflows.
Register for this webinar to learn how this assay can support a compliance strategy and hear directly from the experts driving these innovations in AAV production.
Join Mike Molloy, Technical Director, BA Sciences; and Miguel Dominguez, Global Director, Field Applications and Support, Mirus Bio, for the live webinar on Wednesday, October 22, 2025, at 1pm EDT (10am PDT).
For more information or to register for this event, visit Overcoming Regulatory Hurdles in AAV Production.
ABOUT XTALKS
Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars and digital content to the global life science, food, healthcare and medical device communities. Every year, thousands of industry practitioners (from pharmaceutical, biotechnology, food, healthcare and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps professionals stay current with industry developments, regulations and jobs. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.
To learn more about Xtalks, visit www.xtalks.com
For information about hosting a webinar, visit www.xtalks.com/why-host-a-webinar/
Contact:
Vera Kovacevic
Tel: +1 (416) 977-6555 x371
Email: vkovacevic@xtalks.com
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