WuXi Biologics’ biosafety testing facilities for cell line characterizations, unprocessed bulk lot release and viral clearance validation studies are located in Suzhou with additional support from our other testing facilities in Shanghai. The EMA, NMPA, ISO (CNAS) and CMA certified laboratories in Suzhou are the largest biosafety testing facilities in the Asia-Pacific region and have an outstanding execution and compliance track record. Over 200 highly-trained scientists (~25% with international pharma/biopharma experience) and our efficient project management team work closely with our other integrated services teams to provide our clients an unprecedented single-source service offering for the development and manufacture of a wide-range of biologics produced from mammalian cell culture. Our high-quality biosafety services include:
- Viral clearance/inactivation studies
- Cell line characterization
- Unprocessed bulk lot release testing services
The Suzhou biosafety facility has passed EMA and NMPA audits.
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.
Unprocessed Bulk Lot Release
Each batch of cell harvest material/unprocessed bulk (UBP) must be tested for the presence of adventitious virus and mycoplasma as per ICH Q5A (and other similar global regulatory guidance documents). WuXi Biologics offers in vitro and molecular biology (qPCR) approaches and the applicable USP, EP, JP and ChP methods, under GLP and GMP standards for detection of these microorganisms. We have streamlined the testing, reporting and QA processes to provide expedited timelines for these critical lot release tests. Common assays conducted for release of UBP are shown in Table 1. In addition, similar testing regiments are available for testing and release of critical raw materials if necessary.
|From Pilot Scale Production||From Commercial Scale Production|
|Microbial Limits and Mycoplasma||Bioburden test||✔||✔|
|Microbial Limits and Mycoplasma||Mycoplasma detection
|General Virus Screen||
|Specific Virus Test||
|Quantitation of Retrovirus Particles||
*WuXi Biologics established the first fully cGMP compliant Transmission Electron Microscopy (TEM) lab in China