About the Authors

Hugh I. McFarland

hugh.mcfarland@fda.hhs.gov

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

Montserrat Puig

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

Lucja T. Grajkowska

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

Kazuhide Tsuji

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

Jay P. Lee

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

Karen P. Mason

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

Daniela Verthelyi

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

Amy S. Rosenberg

Affiliation Division of Therapeutic Proteins, Center for Drug Evaluation and Research, U.S. 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: HIM DV ASR. Performed the experiments: HIM LG KT JPL KPM MP. Analyzed the data: HIM MP JPL DV. Wrote the paper: HIM MP ASR.