Under this agreement, WuXi AppTec will provide the relevant viruses, materials and methodologies to Sartorius Stedim Biotech to employ in conducting non good laboratory practice (GLP) viral clearance testing of its technologies with customer products and for supporting its own R&D activities.
The cooperation with WuXi AppTec is expected to benefit customers because non-GLP viral clearance testing during early-stage process development will allow Sartorius to recommend the best viral clearance technology option.
Sartorius and WuXi AppTec will be using the same viruses, materials and methodologies so that customers can reliably anticipate – at this very early stage – predictive study results of what might be expected from WuXi AppTec’s GLP viral clearance testing of the same product as part of the IND process and ultimately the Phase III validation process.