Custom Protein Generation

Drug Substance Manufacturing

Drug Product Fill & Finish

Development

Testing

Discovery

Antibody Drug Conjugates

Technologies & Platforms

Viral Clearance/Inactivation

WuXi Biologics offers custom studies to validate removal and inactivation of viruses from product purification processes. . As a leading contract services provider in Asia, our scientific and quality teams have comprehensive expertise in downstream/purification process development and a wide variety of infectivity and quantitative PCR (qPCR) virus detection assays. All our services meet international regulatory considerations and standards (e.g., ICH, U.S FDA, EMA,NMPA etc.). for early- and late-stage products. The laboratories are BSL-2, ISO 17025/CNAS and CMA certified.
Suzhou-Biotesting-facility-2-banner-800x415

 

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.

Extensive Experience

Our experience spans a broad number of different inactivation or removal unit operations/processes including:

– Heat
– Column
– Low and high pH
– Chromatography
– Solvent / Detergent
– Filtration
– Cleaning
– Kinetics of inactivation
– Resin lifetime studies

testing

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

As preparation, purification and use of high-purity, high-titer viral stocks is one of the most critical aspects in the performance of a viral clearance study, we set the standard for how these stocks should be made with refined and proprietary purification techniques. All of our viral stocks follow a Master Viral Bank, Working Viral Bank convention. Our ultra-purified stocks help ensure the data generated is the most accurate assessment of your processes’ ability to clear or inactivate virus.

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.

 

BACK