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 and TSE 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. 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.

  • Selection of process steps
  • Verification of scaled-down process steps
  • Selection of viruses (TSE spike)
  • Performance of study
  • Interpretation of results
  • Monoclonal antibodies
  • Recombinant proteins
  • Transgenic products
  • Tissue-derived products
  • Blood-derived products
  • Medical devices

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Our Facilities

Learn more about our facilities and capabilities across the globe.

Viral Clearance - Artifacts of Viral Filtration

Despite taking care to ensure that all practices used during validation are in alignment with large-scale manufacturing processes, artifacts are present that can potentially affect virus filter performance (throughput and LRV). Find out how to maximize the chance for success with all validation studies.