U.S. Biologics, Advanced Therapies & Medical Devices Manufacturing and Testing

assay development

WuXi AppTec has developed over 3,000 assays for various types of analytical or biosafety purposes. Custom assays can be transferred from clients and optimized and validated or we can work with clients to develop new assays by utilizing the technical expertise of our analytical, cell biology, virology, molecular biology, and microbiology laboratory staff. Assays are developed and validated for in-process analysis, bulk, and final product lot release (biosafety, purity, potency, identity, and concentration). Using forced degradation experimental designs, stability-indicating methods can be identified for use in stability studies.