Viral clearance (VC) and viral inactivation studies are an essential part of the biologics manufacturing biosafety profile. Viral clearance is a critical consideration throughout the whole project development cycle, from pre-clinical activities to BLA submission. At WuXi Biologics, we have a highly-trained and experienced viral clearance team with hundreds of scientists with the capacity to conduct over 10 VC studies per week.
This world-class team helps our clients design the viral clearance protocol and align it with the downstream purification scheme and regulatory submission needs. Since 2015, we have conducted over 600 projects with a variety of product types and successfully filed with the U.S. FDA, EMA, NMPA, JPMA, or TGA for IND or BLA submissions. Product type experience includes:
- Monoclonal antibodies
- Bispecific antibodies
- Fusion proteins
- Recombinant proteins
- Peptide products
As a leading viral clearance service provider, we are keen to improve your project and knowledge of your purification processes through data mining. Using our experience from over 600 projects, we have established a database that enables us to help you predict the potential viral inactivation/removal rate in each purification step, reduce redundant work, decrease study time and reduce project costs.