Mammalian

At WuXi Vaccines, our analytical development teams facilitate our one-stop R&D endeavors in collaboration with our other discovery and CMC development laboratories. We offer comprehensive, analytical services for a wide variety of vaccines (e.g., VLP and recombinant protein subunit vaccines or antibody-based prophylactic vaccine products).

Our extensive testing services include support of developability studies, in-process analysis, cell line, process and final vaccine product / formulation development, product characterization, lot release, stability studies and IND/BLA/MAA/EUA dossier preparation.

Our vast repertoire of analytical techniques provides the full-range of methods required for biomolecular analysis. Over 1,000 established methods including compendial, physicochemical, biochemical, biophysical and biological assays (bioassays) supported by our highly-experienced teams are available. From new vaccine discovery to regulatory filing, we manage a method’s lifecycle from development to qualification/validation and transfer to Quality Control or other departments and provide investigation and troubleshooting support as needed. Equipped with cutting-edge instrumentation and first-class talents, we provide systematic solutions for integrated projects while catering to special analytical needs in the form of standalone projects.

Comprehensive analytical services to support CMC Development