As the first non-state affiliated lab of its type in China and Asia, WuXi Biologics is one of the rare CDMOs that offer in-house biosafety testing capabilities. These capabilities allow WuXi Biologics to reduce our clients’ drug development timelines because we eliminate the problematic hand-offs inherent in the historic multiple vendor model. If using our standard cell line, cell culture and purification technology platforms these timelines can be streamlined even further.
The Suzhou biosafety facility has passed EMA and NMPA audits.
– Low and high pH
– Solvent / Detergent
– Kinetics of inactivation
– Resin lifetime studies
The team in Suzhou have completed over 200 viral clearance studies to support over 100 client INDs and multiple BLAs with no study or report rejections. Approximately 25% of our studies have been “dual-filing” programs where in parallel we conduct the studies to meet both U.S. FDA or EMA or NMPA requirements. Viral clearance studies have also been conducted for IND and BLA submissions in Japan and Australia.
High-purity, High-titer Virus Stocks
Real-time Quantitative PCR Assays
For processes in which both clearance/removal and inactivation occur, qPCR has become a leading technology in determining clearance and removal, or to complement standard viral titration assays. We developed over 15 qPCR assays to common model viruses used in viral clearance studies.
Large-volume Virus Plaque Assays
We have performed many studies in combination with the use of the virus plaque assay which demonstrates that a higher-log reduction value can be realized for a given process step. Utilizing the virus plaque assay and large volume sampling not only allows for a higher claim of LRV but has also proven to be a more precise method for detection of infectious units for most viruses.