Xiuju Lu, PhD U.S. FDA

Xiuju (Sue) Lu is a regulatory reviewer in the Division of Manufacturing and Product Quality (DMPQ), Office of Compliance and Biologics Quality (OCBQ), CBER. Xiuju’s review scope includes the chemistry, manufacturing and control and facility sections of biologics or device applications. Xiuju evaluates facility design, operation, manufacturing and testing procedures and compliance with GMPs, conducts pre-licensing and preapproval inspections for BLAs and supplements, and provides advice to manufacturers through regulatory meetings on cGMP, facilities, contamination prevention and manufacturing of pharmaceutical products.

Prior to joining FDA, Xiuju performed and led Research & Development studies in cancer immunotherapy and vaccine development in industry. Xiuju holds degrees of bachelor and PhD in Chemical Engineering in China, and postdoctoral trainings in molecular and cellular immunology in Oregon Health & Science University (OHSU) and National Institutes of Health (NIH).