Viral Clearance Studies Services
Our scientists have more than 20 years of experience in supporting clients throughout the design and performance of viral clearance studies. The procedures at our purpose built facilities, located in both the United States and Europe, have been harmonized to allow for easy transfer and performance of studies for our global client base.
Using a customized approach we can provide technical advice and regulatory support to ensure that a successful viral clearance 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, Charles River is able to assist clients in developing, executing and evaluating viral clearance studies in the following ways:
• Assistance in the selection of the process steps evaluated
• Verification of the scaled-down process steps
• Selection of viruses or TSE spike solutions
• Determination of test article cytotoxicity (virus) and interference (virus/TSE)
• Performance of the process steps in the presence of virus/TSE spike
• Evaluation of the virus/TSE removal and inactivation
Product Experience includes:
• Monoclonal antibodies (mAbs)
• Recombinant proteins
• Transgenic products
• Tissue-derived products
• Blood-derived products
• Medical devices
• Vaccines
• Virus cleaning validation