Manufacturers of biopharmaceutical products, products derived from animal or human tissues, blood products and some medical devices are required to assess the ability of their purification and manufacturing processes to produce a product that is safe for use in humans. Studies designed to demonstrate the capacity of the downstream process to inactivate or remove viruses and transmissible spongiform encephalopathy (TSE) agents are required by regulatory authorities as an integral part of any investigational new drug (IND) submission prior to administration of a product in humans.
At Charles River Biopharmaceutical Services (BPS), we have expert scientists in both the US and Europe who have more than 15 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 reports generated to meet your deadlines. All process validation/viral clearance studies are performed under strict regulatory compliance guidelines according to Q5A, US Food and Drug Administration (FDA) “Points to Consider” and the European Medicines Agency (EMA) “Guidelines of Viral Safety Evaluation.”
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
For more information, please contact us at askcharlesriver@crl.com or 1.877.CRIVER.1.