Viral Clearance Studies

Any biotherapeutic needs to maintain a high standard of purity. Viral contaminants can potentially alter the biological activity of the product, leading to reduced efficacy or adverse effects, and pose risks to patients health.

Viral contamination can occur at various stages of the manufacturing process, from raw materials to final product packaging. Furthermore, detecting viral contamination is more complex than identifying other types of microbial contaminants, making effective viral clearance studies particularly challenging and intricate.

Regulatory agencies, such as the FDA and EMA, require thorough viral clearance validation as part of the approval process.

Given the vital role of viral clearance studies, a strategic process design and a tight collaboration with an experienced testing laboratory is a paramount to achieve adequate viral clearance and meet stringent safety standards.

• With a a dedicated 450 sqm BioSafety Level 2 laboratory we can implement a well-designed viral clearance strategy that identifies and mitigates risks early in the development process.
• With 25+ years of experience in virology, we provide customised solutions tailored to address all the challenges of your product and manufacturing process.
• Customised Solutions: Each biopharmaceutical and biologic product is unique, and a standard approach doesn’t work for viral clearance. We provide customised solutions offering a strategic process design tailored to address the particular challenges of your product and manufacturing process.
• Comprehensive Reporting: Our detailed reports provide clear and comprehensive documentation of all aspects of the study. This includes methodology, results, risk assessments, and recommendations, ensuring all the information needed for regulatory submissions.

We can help you:

• Identify the steps in your manufacturing process that inactivate or remove viral contaminants
• Select test viruses relevant for your product
• Design the down-scale of your process and validate it at lab-scale
• Implement a thorough document including all aspects of the study and the results of the clearance validation necessary for regulatory submission
• Meet your deadlines: A dedicated project manager will be assigned to each validation to assure coordination and timelines

By choosing to work with us, you’re partnering with a team dedicated to ensuring the safety and efficacy of your biopharmaceutical and biologics products. Our background of successful viral project studies and satisfied clients attests our reliability and effectiveness.