About the Authors

Mohanraj Manangeeswaran

Contributed equally to this work with: Mohanraj Manangeeswaran, Derek D. C. Ireland

Affiliation Division of Biotechnology Review and Research-III, Office of Biotechnology Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, United States of America

Derek D. C. Ireland

Contributed equally to this work with: Mohanraj Manangeeswaran, Derek D. C. Ireland

Affiliation Division of Biotechnology Review and Research-III, Office of Biotechnology Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, United States of America

Daniela Verthelyi

Daniela.Verthelyi@fda.hhs.gov

Affiliation Division of Biotechnology Review and Research-III, Office of Biotechnology Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, United States of America

Competing Interests

The authors have declared that no competing interests exist.

Author Contributions

Conceptualization: MM DDCI DV. Data curation: DV. Formal analysis: DV. Funding acquisition: DV. Investigation: MM DDCI. Methodology: MM DDCI DV. Project administration: DV. Resources: DV. Supervision: DV. Validation: DV. Visualization: MM DDCI DV. Writing – original draft: MM DDCI DV. Writing – review & editing: MM DDCI DV.