Cell and gene therapy regulatory testing is a constantly evolving discipline as the field matures and data becomes more refined. Virology Operations at WuXi Advanced Therapies is able to provide testing for a variety of products ranging from small non-enveloped AAV vectors to large enveloped lentiviral vectors.

Our testing is performed as quickly as testing parameters permit without sacrificing the quality and integrity of results. Our panel of testing satisfies all ICH parameters delivering results on the quantity, stability, potency, identity, appearance, purity and safety of viral vector products.

We are evolving with the field to optimize our assays such as replication competence testing and infectious titer assays for scalability; we accommodate needs as products progress from early R&D and IND phase through clinical trials with the goal of sustaining the testing requirements and supporting through commercial release.