Summary
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.
Watch this video of the Cell & Gene Therapy Insights Live 30 webinar and panel discussion held on February 25th, 2025
- 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