Viral Clearance & TSE Clearance Studies

Viral Clearance & TSE Clearance Studies

Clearance studies are an essential part of a manufacturer’s program to ensure product safety. Alongside characterization of starting materials and product testing, analysis of the manufacturing process’s ability to remove or inactivate a wide range of model viruses or TSE agents is vital for establishing the safety of biological products.

Viral & Transmissible Spongiform Encephalopathy Clearance

Charles River scientists have over 20 years of experience in designing and conducting viral and transmissible spongiform encephalopathy (TSE) clearance studies. With laboratories in Europe and the US, we ensure compliance with global regulatory guidelines (EU, US, Japan, WHO, including ICH Q5A).
Our tailored study designs and robust reporting create cost-effective programs suited to each biopharmaceutical product, including monoclonal antibodies (mAbs), recombinant proteins, transgenic products, tissue- and blood-derived products, vaccines, and medical devices.
We also offer virus cleaning validation.

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CLEARANCEPLUS PLATFORM

Demonstrating the ability of manufacturing processes to remove or inactivate known and unknown contaminants is critical in biologic production.
Manufacturers of biopharmaceutical products or materials derived from animal or human tissues (e.g., blood products, recombinant proteins, vaccines, hormones, polyclonal antibodies, enzymes, medical devices containing blood-derived components) must verify virus and TSE clearance capability.

Charles River’s database of over 2,500 studies supports optimized study design, execution, and reporting to meet regulatory submission requirements.

ClearancePlusSM Platform Integrates:

• Risk-based assessments: Review of viral safety testing, production processes, and raw materials to minimize required testing and optimize study design.
• Holistic study design: Selection of virus spikes, sampling modes, detection methods, and assay sensitivities for effective clearance studies.
• Optimized sensitivity: Inclusion of large-volume plating for all relevant samples to improve LRV claims and demonstrate robust virus reduction.
• Regulatory expertise: Compliance with US FDA, EMA, ICH, and other global regulatory standards.
• Customized service: Support for diverse product types and purification steps, including downscale assistance, execution, and troubleshooting.
• Industry leadership: Application of best practices from internal studies and global viral safety presentations to ensure scientifically sound designs.

FACILITIES

Charles River operates harmonized viral clearance facilities in the United States and Europe, allowing seamless global study transfer and execution.
Each facility offers dedicated client laboratories and private offices for efficient on-site collaboration.
Both sites are equipped with fully qualified and validated ÄKTAexplorer, purifier, pure, and avant chromatography systems.

SUPPORT SERVICES

Charles River provides comprehensive support services throughout viral clearance program planning and execution.

Key offerings include:

• Skilled scientists for all process steps, including chromatography
• Option for Charles River scientists to perform process steps offsite
• Regulatory consulting to ensure compliance with US, EU, Japanese, and global standards
• Expert statements, virus risk assessments, and on-site seminars or training
• Dedicated project managers and the mycharlesriver℠ secure online data portal for clear communication and on-time delivery

Our goal is to build lasting partnerships and exceed client expectations for quality and reliability.