Viral Clearance Studies

Our scientists, located in both the United States and Europe, have more than 20 years of experience in supporting clients throughout the design and performance of viral clearance studies. Using a customized approach, we can provide technical advice and regulatory support to ensure that a successful program is established and reported to meet your deadlines. Our viral clearance studies are performed under strict regulatory compliance according to ICH Q5A, FDA Points to Consider and the EMA Guidelines on Viral Safety Evaluation. TSE clearance studies are also available. With a database of over 2,000 studies on a diverse array of products, our viral clearance experts can help design a study that meets your specific needs.

Need Help With Your Viral Clearance Study?

From downscale assistance to report generation, our promise to clients is successful study design and execution and a report that will support their regulatory submission and not lead to delays in approvals. Our ClearancePlus platform integrates:

  • Risk-based Assessments – comprehensive review of your viral safety testing program, production processes and raw material quality in order to minimize required viral clearance and ensure an economic study design
  • Holistic Study Designs – review of required pretesting, virus spikes, sampling modes, detection methods and assay sensitivities to define the most effective virus clearance study approach
  • Optimized Sensitivity – standard inclusion of large volume plating for all product-relevant samples to demonstrate effective and robust virus reduction
  • Regulatory Expertise – alignment of study design and reporting with the development stage of the product and compliance with national and global regulations outlined in US FDA, EMA, ICH and other country-specific regulatory documents

We will customize your study to meet the needs for your particular product and assist you every step along the study planning, execution and reporting process.

Study Design

  • Selection of process steps
  • Verification of scaled-down process steps
  • Selection of viruses (TSE spike)
  • Performance of study
  • Interpretation and troubleshooting of results

Product Experience

  • Monoclonal antibodies
  • Recombinant proteins
  • Transgenic products
  • Tissue-derived products
  • Blood-derived products
  • Medical devices

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Viral Clearance Webinar Series

Have questions about viral clearance studies? This series of webinars guides you through processes that are involved when designing, executing and evaluating a viral clearance study.

Viral Clearance by Affinity and AEX Chromatography

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Opening of New Viral Clearance Laboratory

We increased the capacity of our Cologne, Germany facility with the addition of another fully equipped viral clearance suite, designed to offer enough space to run different process steps in parallel and make it possible to complete a late-stage viral clearance study within a week.