Viral Clearance Studies

A critical part of the biologic manufacturing process is demonstrating that the process appropriately removes or inactivates potential known and unknown contaminants. Manufacturers of biopharmaceutical products derived from animal or human tissues, such as blood products, recombinant proteins, vaccines and even some medical devices, are required to demonstrate the ability to their purification and manufacturing processes to inactivate or remove viruses and, for some products, transmissible spongiform encephalopathy (TSE) agents. Such studies are required by regulatory authorities as an integral part of a submission report prior to administration of a product to humans.

At Charles River, three complementary approaches are offered to ensure the viral clearance of a biotechnology product.