Tailoring viral clearance study design to development phase, modality, and regulatory requirements

Wednesday 08:00 PST / 11:00 EST / 16:00 GMT / 17:00 CET

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Tailoring viral clearance study design to development phase, modality, and regulatory requirements

Live30 webinars pack the latest innovations and applications into a data-rich 30-minute session.

Minaris Advanced Testing has conducted more than 3,000 viral clearance studies with zero regulatory rejections. In this webinar, their Head of Viral Clearance will share insights, case studies, and strategies to design robust viral clearance studies that meet ICH Q5A(R2), WHO, FDA, and EMA expectations – whether preparing for IND, IMPD, or BLA submission.

Attend for key insights on:

Challenge virus selection – Frameworks for choosing appropriate model viruses and spiking strategies for advanced modalities such as AAV products.
Performance benchmarks – Typical clearance log reduction values (LRVs), mass balance study results, and orthogonal clearance validation data across virus types.
Phase-specific approaches – How to balance regulatory rigor with development speed in early- versus late-phase studies.
Regulatory alignment – Practical insights on meeting ICH Q5A(R2), WHO, FDA, and EMA expectations, including the latest updates and their implications.
Case studies in practice – Examples from over 3,000 viral clearance studies that illustrate common pitfalls, streamlined approaches, and strategies to reduce timelines.
Submission-ready outputs – Practical strategies for CMC filings, including data presentation frameworks and harmonized study elements that support regulatory success.

Register now to learn about:

Actionable guidance for tailoring viral clearance studies to your program’s stage and modality
Data-driven benchmarks to support decision-making and strengthen regulatory submissions
Best practices for complex modalities such as AAV vectors, where traditional clearance methods require adaptation
Avoiding common pitfalls in order to keep studies on track for regulator

Kathleen Kenney

Director, Viral Clearance at Minaris Advanced Therapies

Kathleen has been working with Minaris Advanced Therapies for more than 13 years. She began her career with the company as a laboratory technician and has held the roles of 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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