Studies designed to demonstrate the capacity of a manufacturing process to inactivate or remove viruses and transmissible spongiform encephalopathy (TSE) agents are required by regulatory authorities for animal- or human-derived products (e.g., cell cultures) as an integral part of any submission report prior to administration of the product in humans.
At Charles River Biopharmaceutical Services (BPS), we have expert scientists in both the US and Europe who 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 are able to provide technical advice and regulatory support to ensure that a successful and cost-effective program is established and reports are generated to meet your deadlines. All process validation/viral clearance studies are performed according to ICH Q5A and European, US, Japanese and WHO regulatory guidelines.
We have two new purpose-built facilities for viral clearance studies, one in the United States and one in Europe. The procedures at these sites have been harmonized to allow for easy transfer and performance of studies for our global client base. We provide extended services, including performance of almost all downscaled process steps (e.g., virus-retentive filtration, inactivation, chromatography), which means more flexibility and improved timelines for clients.
Capabilities
- cGMP- and GLP-compliant viral clearance studies
- Qualified GE AKTA Purifier and Explorer chromatography systems
- Pilot lyophilization machine
- Performance of most downscaled process steps according to client's protocols
- Downscale service
- Human and animal viruses available as high-titer stocks (>107 PFU/mL/>107 TCID50/mL)
- Infectivity assays performed in real time
- Large-volume assay format available to improve LRV claims
- Q-PCR assays available
- Supporting Microbiology and Molecular and Cellular Biology services
- Regulatory advice and consulting
- Available to conduct seminars at client sites
- Database of more than 2000 GLP studies
Product Experience
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Monoclonal antibodies
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Recombinant proteins
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Transgenic products
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Tissue-derived products
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Blood-derived products
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Medical devices
Visit our Regulatory Document Library to access regulatory documents on viral and TSE clearence from the FDA, EMA, MHLW, WHO and more.
To check which of our BPS facilities perform viral and TSE clearance studies, click here. For additional information, contact us at askcharlesriver@crl.com.
Related Information
News: EMD Millipore Partners with Charles River for Improved Viral Clearance Studies