Viral Clearance
Viral Clearance: ensure the safety of biopharmaceuticals and medical devices for human use.
Viral clearance studies are required to assess the safety of biopharmaceuticals, such as blood products, monoclonal antibodies, recombinant proteins, tissue derived products, and medical devices prior to entering clinical trials and ahead of commercial launch.
Raw materials of animal origin, used to obtain biopharmaceutical product and medical devices, may contain viruses dangerous to human health. The EU legislation requires manufacturers of biopharmaceutical products or medical devices to demonstrate the ability of manufacturing and purification processes to inactivate or remove viruses [EMA CPMP/BWP/268/95 (biopharmaceutical products) and ISO 22442-3 (medical devices)].
The objective of viral clearance studies is to evaluate the ability of the manufacturing process to inactivate/remove known viral contaminants, and to estimate process robustness by characterizing its ability to clear model viruses resembling virus that might be present in the raw material.
The control of biopharmaceuticals and medical devices must take place at 3 levels:
- selecting and testing the raw material, i.e. cell lines, tissues, organs, media components, for the absence of undesirable viruses which may be infectious and/or pathogenic for humans;
- assessing the capacity of the production processes to clear infectious viruses;
- testing the product at appropriate steps of production for the absence of contaminating infectious viruses.
It is extremely important that the design, planning and execution of the viral clearance study are discussed in details with the Customer. Thanks to the wide experience of Mérieux NutriSciences Specialists, we are able to assist you from the very beginning for outlining the whole study and we will guide you through the selection of the steps to challenge for demonstrating viral clearance.
