Viral Clearance Studies
Manufacturing processes of pharmaceuticals or medical devices must be able to remove or to inactivate known and unknown viral contaminants. Viral clearance validations are performed in a down-scaled manufacturing process to determine the inherent virus elimination capacity. Our extensive experience in virology permits us to respond flexibly to customer requests and to apply our experience in downscaling of production processes and project implementation.
Viral clearance studies are performed according to national and international guidelines:
- EN ISO 22442:2007 Medical devices utilizing animal tissue and their derivatives - Part 1-3: Validation of the elimination and/or inactivationof viruses and transmissible spongiform encephalopathy (TSE) agents
- EMEA CPMP/ICH/295/95 ICH Topic Q 5 A (R1): Quality of Biotechnological Products: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
- EMEA CPMP/BWP/268/95 Note for guidance on virus validation studies: The design, contribution and interpretation of studies validating the inactivation and removal of viruses
- EMEA/CHMP/BWP/398498/2005 Guideline on virus safety evaluation of biotechnological investigational medicinal products