Summary
Cell and gene therapies and other traditional biologics like vaccines and Monoclonal Antibodies, require extensive safety testing all the way from raw materials to commercial lot release. The inherent variability
of biologics, small sample sizes and the need for rapid turn- around times all add to the complexity of the testing environment.
WuXi Advanced Therapies has a strong track record; we’ve supported over 1700 customers with
biosafety testing for global submissions. Our team has significant expertise in assay development, biosafety testing, viral clearance, and commercial lot release testing.
Importantly, our new purpose-built testing facility at 400 Rouse Boulevard in Philadelphia consists of 140,000 square feet of GMP compliant, flexible laboratory space, tripling our capacity for both integrated and external testing programs.