Modernizing viral clearance study strategy: regulatory updates and industry best practices

Live30 webinars are thirty-minute presentations designed to update you on the latest innovations, applications, and data in a fast yet interactive format.

All biological products are required by regulators to undergo viral clearance (VC) studies to demonstrate product safety and establish patient safety. However, since all viral clearance studies are product-specific, there is no standard design template or approach. 

Attend this webinar for insights into strategies to ensure the success of VC projects on a wide range of products and manufacturing processes, incorporating industry best practices from initial query to final report. Types of products and phase appropriate considerations will be reviewed, based on real-life case studies. 

Additionally, The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) which brings together regulatory authorities and the pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop guidelines, recently revised ICH Q5A (R2) to include updated recommendations concerning the design and execution of VC studies. These updates will be discussed and reviewed.

Attend this webinar for:

• Guidance on how to implement the revised recommendations included in ICH Q5A(R2) guidelines
• Insights from experts who have conducted multiple studies across a variety of products
• Advice on how to design studies with quality requirements in mind, and conduct them in a way that is appropriate for the clinical phase of your product

Audrey Chang

Executive Director at WuXi Advanced Therapies

Dr Chang has over 28 years of government and industry experience in conducting biological product testing and in managing laboratories. Audrey earned her PhD at the Johns Hopkins University in Biology, and after a post doc at the FDA, joined BioReliance where she held various positions of increasing responsibilities. Prior to joining Wuxi Advanced Therapies, Audrey was VP of QC at Vigene BioSciences which was acquired by Charles River Laboratories. In her current role, Audrey provides technical solutions and support to clients for both traditional biologics and novel modalities. Audrey has always had a passion for driving innovative products to commercialization and is happy to bring her experience to WuXi Advanced Therapies.

Kathleen Kenney

Director, Viral Clearance at WuXi Advanced Therapies

Kathleen has been working with WuXi Advanced Therapies for more than 13 years. She began her career with the company as a laboratory technician and has held the roles as study director, supervisor and manager, ultimately earning the position of Director of the viral clearance team. With her significant career and track record of conducting or overseeing dozens of studies, Kathleen is well equipped to share pragmatic and actionable advice in study design.

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SPEAKERS

Audrey Chang

Executive Director at WuXi Advanced Therapies

Kathleen Kenney

Director, Viral Clearance at WuXi Advanced Therapies

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