About the Authors

Laura Ulitzky

Affiliation Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, 20993–0002, United States of America

Manuel M. Lafer

Affiliation Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, 20993–0002, United States of America

Mark A. KuKuruga

Affiliation Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, 20993–0002, United States of America

Erica Silberstein

Affiliation Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, 20993–0002, United States of America

Nicoleta Cehan

Affiliation Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, 20993–0002, United States of America

Deborah R. Taylor

Deborah.Taylor@fda.hhs.gov

Affiliation Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, 20993–0002, United States of America

Competing Interests

The authors have declared that no competing interests exist.

Author Contributions

Conceived and designed the experiments: LU DRT. Performed the experiments: LU MML MAK NC ES. Analyzed the data: LU DRT. Wrote the paper: LU DRT.