Recent advances in (therapeutic protein) drug development [version 1; referees: 2 approved]

H.A. Daniel Lagassé; Aikaterini Alexaki; Vijaya L. Simhadri; Nobuko H. Katagiri; Wojciech Jankowski; Zuben E. Sauna; Chava Kimchi-Sarfaty

doi:10.12688/f1000research.9970.1

F1000Research (Feb 2017)

Recent advances in (therapeutic protein) drug development [version 1; referees: 2 approved]

H.A. Daniel Lagassé,
Aikaterini Alexaki,
Vijaya L. Simhadri,
Nobuko H. Katagiri,
Wojciech Jankowski,
Zuben E. Sauna,
Chava Kimchi-Sarfaty

Affiliations

H.A. Daniel Lagassé: Hemostasis Branch, Division of Plasma Protein Therapeutics, Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA
Aikaterini Alexaki: Hemostasis Branch, Division of Plasma Protein Therapeutics, Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA
Vijaya L. Simhadri: Hemostasis Branch, Division of Plasma Protein Therapeutics, Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA
Nobuko H. Katagiri: Hemostasis Branch, Division of Plasma Protein Therapeutics, Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA
Wojciech Jankowski: Hemostasis Branch, Division of Plasma Protein Therapeutics, Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA
Zuben E. Sauna: Hemostasis Branch, Division of Plasma Protein Therapeutics, Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA
Chava Kimchi-Sarfaty: Hemostasis Branch, Division of Plasma Protein Therapeutics, Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA

DOI: https://doi.org/10.12688/f1000research.9970.1
Journal volume & issue: Vol. 6

Abstract

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Therapeutic protein drugs are an important class of medicines serving patients most in need of novel therapies. Recently approved recombinant protein therapeutics have been developed to treat a wide variety of clinical indications, including cancers, autoimmunity/inflammation, exposure to infectious agents, and genetic disorders. The latest advances in protein-engineering technologies have allowed drug developers and manufacturers to fine-tune and exploit desirable functional characteristics of proteins of interest while maintaining (and in some cases enhancing) product safety or efficacy or both. In this review, we highlight the emerging trends and approaches in protein drug development by using examples of therapeutic proteins approved by the U.S. Food and Drug Administration over the previous five years (2011–2016, namely January 1, 2011, through August 31, 2016).

Published in F1000Research

ISSN: 2046-1402 (Online)
Publisher: F1000 Research Ltd
Country of publisher: United Kingdom
LCC subjects: Medicine; Science
Website: https://f1000research.com

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Abstract

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