Zhaohua Zhou

PhD

Speciality: Senior Scientist
Company: CDER/FDA
Designation: Senior Scientist, Office of Pharmaceutical Quality Research

Personal Information

Dr. Zhou is a Senior Research Scientist at the Office of Pharmaceutical Quality Research, CDER, US Food & Drug Administration. His research is dedicated to developing laboratory models for identifying and predicting drug-induced acute allergic reactions, with a particular focus on elucidating the root causes and devising in vitro diagnostic methods for polyethylene glycol (PEG)-induced drug allergies. This includes PEG-contained drug delivery systems, such as lipid nanoparticle-based drugs and vaccines like the mRNA/LNP COVID vaccines.

By utilizing comprehensive models, Dr. Zhou can efficiently assess whether drug quality contributes to allergic reactions and predict patient sensitivity to specific therapeutics. Furthermore, he possesses regulatory expertise within the FDA, including biotherapeutic CMC assessment and immunogenicity method assessment.

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