The Road to Approval: Viral Clearance Strategies for Non-Enveloped Viral Vectors

WEBINAR

The updated ICH Q5A(R2) guideline incorporates viral vectors in its viral safety guidance, including the expectation for a viral clearance study for non-enveloped viral vectors. Designing a viral clearance study for a non-enveloped viral vector requires thoughtful consideration of the risk of any adventitious, endogenous or production viruses that might be present as a potential contaminant. Viral clearance steps should be implemented in the manufacturing process that will selectively inactivate or remove potential contaminants without any detrimental impact to the vector. A well-designed viral clearance study will contribute to the assurance of a vector’s overall viral safety on your journey to regulatory approval.

In this webinar, you will learn:

• How to identify the sources of potential viral contaminants and develop steps in the manufacturing process to selectively remove or inactivate them
• The differences between designing a viral clearance study for a non-enveloped viral vector versus a study to support a monoclonal antibody or recombinant protein
• Why a viral clearance study for viral vector may evaluate fewer steps than a study for a monoclonal antibody or recombinant protein
• The existing principles for evaluation of inactivation, filtration and chromatography steps apply to a clearance evaluation for a viral vector product