WuXi Biologics’ biosafety and cell characterization testing facilities are located in Suzhou and Shanghai.
Our high-quality services include:
- Viral clearance/inactivation studies
- Cell line characterization
- Unprocessed bulk lot release testing services
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.
WuXi Biologics offers custom studies to validate removal and inactivation of viruses from product purification processes. Combined with our U.S. affiliates, we are a global leader in this field with more than three decades of experience. Our scientific and quality teams have comprehensive expertise in process development and a wide variety of infectivity and quantitative PCR virus detection assays. All our biosafety services meet international regulatory considerations and standards for early- and late-stage products.
Our experience, along with our WuXi AppTec affiliates, spans a broad number of different inactivation or removal unit operations/processes including:
– Heat / Pasteurization
– Low and high pH
– Solvent / Detergent
– Kinetics of inactivation
– High-energy light
– Coupon studies
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. 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 / Large-volume Virus Plaque Assay
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.
Additionally, we have performed many large-volume studies, in combination with the use of the virus plaque assay which have demonstrated 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.
Cell Line Characterization (CLC)
Successful characterization of Master, Working and End-of-Production Cell Banks has many essential elements, including identity and detection of micro-organisms, mycoplasma and adventitious virus. WuXi Biologics along with its U.S.-based WuXi AppTec affiliate are a global leader in this field, with exceptional expertise and over 30 years of experience. Dedicated virology, molecular biology, cell biology, in-life and microbiology labs provide high-quality and comprehensive CLC services that meet ICH and CFDA (renamed NMPA) guidelines for a wide-variety of cell line types.
- Sterility testing
- Mycoplasma detection
- Cell line identity
- Cell morphology and growth characteristics
- Adventitious virus detection via in vitro, in vivo & qPCR methodologies
- Testing for bovine or porcine viruses (9CFR requirement)
- Cell line clonality, transgene stability, integration sites and copy number determination
Unprocessed Bulk Lot Release
Cell harvest material/unprocessed bulk must be tested for the presence of adventitious virus and mycoplasma. WuXi Biologics offers in vitro and molecular biology (qPCR) approaches under GLP and GMP standards for detection of these micro-organisms.