About the Authors

Erica Silberstein

Affiliation Division of Emerging and Transfusion-transmitted Diseases, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland, United States of America

Kathleen Mihalik

Affiliation Division of Viral Products, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland, United States of America

Laura Ulitzky

Affiliation Division of Emerging and Transfusion-transmitted Diseases, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland, United States of America

Ewan P. Plant

Affiliation Division of Emerging and Transfusion-transmitted Diseases, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland, United States of America

Montserrat Puig

Affiliation Division of Therapeutic Proteins, Center for Drug Evaluation and Research, Food and Drug Administration, Bethesda, Maryland, United States of America

Sara Gagneten

Affiliation Division of Viral Products, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland, United States of America

Mei-ying W. Yu

Affiliation Division of Hematology, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland, United States of America

Neerja Kaushik-Basu

Affiliation Department of Biochemistry and Molecular Biology, University of Medicine and Dentistry of New Jersey, Newark, New Jersey, United States of America

Stephen M. Feinstone

Affiliation Division of Viral Products, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland, United States of America

Deborah R. Taylor

deborah.taylor@FDA.HHS.gov

Affiliation Division of Emerging and Transfusion-transmitted Diseases, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland, United States of America

Competing Interests

The authors have declared that no competing interests exist.

Author Contributions

Conceived and designed the experiments: ES DRT. Performed the experiments: ES KM LU EPP MP SG. Analyzed the data: ES NKB DRT. Contributed reagents/materials/analysis tools: MyWY SMF. Wrote the paper: ES DRT.