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Analytical Development

The Analytical Sciences (AS) department at WuXi Biologics facilitates our one-stop new drug R&D  endeavors in collaboration with our other discovery and CMC development laboratories. We offer comprehensive, analytical services for new drug development, including developability studies in-process CMC support, product characterization, lot release, stability studies and IND/BLA dossier preparation. 

Our vast repertoire of analytical techniques provides the full-range of methods required for biomolecular analysis. Over 100 established methods including compendial, physicochemical, biochemical, biophysical and  biological assays are available. Our highly experienced analytical team   supports more than 100 projects each year, generating bioanalytical data on a phenomenal scale while also providing investigation and troubleshooting support. From new drug discovery to new drug application, we manage a method’s lifecycle from development to qualification/validation and transfer to Quality Control or other departments as needed. Moreover, AS is home to three Centers of Excellence (CoE), focusing on bioassay, mass spectrometry and forensic analysis. 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.

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