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Yonggang Wang

Senior Cmc Reviewer and Staff Scientist @FDA

Silver Spring, MD, US
EMAILS
[email protected]
MOBILE NUMBERS
+13•••••••98

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WORK HISTORY

Sep 2018 — Present

Senior Cmc Reviewer and Staff Scientist @FDA

Regulatory: CMC review of IND, BLA, FDA meetings, facility inspections. Area of specialization: Plasma fractionation, process validation (drug substance and drug product), raw materials qualification, bulk and final product filling control, assay validation, toxicology assessment, specification, lot release, product stability, deviations/investigations, cGMP/GLP, facility inspection. Research: Undertake and maintain mission-relevant research on WHO and CBER reference materials, Hemolysis, Ebola Virus, and Vaccinia virus.

EDUCATION

1997 — 2000

Shanghai Institue of Pharmaceutical Industry

Master of Science - MS, Bio-pharmaceuticals

2001 — 2004

Kyushu University

Doctor of Philosophy - PhD, Molecular and Cell Biology

1992 — 1997

Dalian Medical University

Doctor of Medicine - MD, Medicine

ABOUT YONGGANG WANG

FDA CMC reviewer & inspector - Office of Protein Therapeutics CMC| Office of Therapeutic Products | Center for Biologics Evaluation and Research (CBER).Regulatory: CMC review of 290+ IND, BLA, Pre-IND, Pre-BLA submissions for biologics(especially human and animal-derived immune globulin products), including IVIG/IGIV, IGSC, IGIM, Hyperimmune IG, F(ab)`2, recombinant therapeutic proteins (IgG-Fc moieties). Pre-Approval and Post-Approval & FDA’s Office of Regulatory Affair (ORA) Surveillance (Routine) cGMP inspections and compliance follow up of foreign and domestic manufacturers. Research: WHO reference material for immune globulin products, IVIG/IGIV-induced hemolysis adverse event/mechanism, Monoclonal antibody, CBER reference materials for Ebola virus antibodies, pathogenesis and treatment of Vaccinia virus infection.

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