The 20,000-square-foot laboratory in Minnesota will offer expanded capacity for existing services, like particle identification and extractable/leachable testing, and add a new service—dynamic light scattering for nanoparticle characterization. These services are required by the FDA for filings of medical devices or biologics. The expansion is designed on a flexible floor plan that allows rapid scale-up of technologies to increase capacities for chemical analysis of medical materials.
The new expanded laboratory is expected to be operable by the end of June.
"WuXi is committed to helping medical device and biologics companies bring their products to market faster," said Ge Li, chairman and CEO of Wuxi. "This facility and Wuxi's trained staff will better serve our customers' growing need to quantify the chemical safety of materials used in medical devices and biologics."
Biosafety Testing Facility in Suzhou
The biosafety testing facility in Suzhou, China, consists of 38,000 square feet of laboratories and support areas in a building adjacent to WuXi's GLP preclinical drug safety facility. Operations will begin after validations are completed this summer. Offerings from the facility will include clinical and commercial lot release programs, viral clearance testing, and virus and molecular-based safety detection services for Chinese and multinational customers.
The new services will expand WuXi's biologics services and will mirror the company’s US offerings, which includes biosafety testing services such as viral clearance validation and lot release and stability testing.
In China, the company's services include novel monoclonal antibody discovery, discovery biology, drug screening, cell-line engineering and construction, toxicology, bioanalytical services, assay development, formulation, process development, and cGMP drug-substance and drug-product manufacturing for clinical trials.
"WuXi's expanding capabilities help our customers advance their biologic product candidates through development more quickly and cost-effectively," Li said.