Human-Derived and Animal-Derived Products

Human- and animal-derived products possess a significant contamination risk from viral and TSE agents for manufacturers. To remove such adventitious agents, careful assessment is required of biopharmaceuticals, biological raw materials, and APIs used to manufacture these products.

Charles River’s extensive technical and regulatory experience in the assessment of these safety risks, as well as in the conduct of laboratory-based studies, allows us to provide scientific and regulatory support to ensure the most appropriate studies are performed.

Our services include:

• Retrovirus testing
• Adventitious agent testing
• Virus and TSE validations
• Product release testing
• Expert report assessment

Our human- and animal-derived product testing programs will help you accelerate your efforts to assure product safety and to meet FDA, ICH, and CPMP guidelines.

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