title: Recent advances in (therapeutic protein) drug development.
abstract: 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).
authors.affiliation: 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.
authors.forename: H A Daniel
authors.initials: HA
authors.lastname: Lagassé
authors.affiliation: 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.
authors.forename: Aikaterini
authors.initials: A
authors.lastname: Alexaki
authors.affiliation: 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.
authors.forename: Vijaya L
authors.initials: VL
authors.lastname: Simhadri
authors.affiliation: 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.
authors.forename: Nobuko H
authors.initials: NH
authors.lastname: Katagiri
authors.affiliation: 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.
authors.forename: Wojciech
authors.initials: W
authors.lastname: Jankowski
authors.affiliation: 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.
authors.forename: Zuben E
authors.initials: ZE
authors.lastname: Sauna
authors.affiliation: 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.
authors.forename: Chava
authors.initials: C
authors.lastname: Kimchi-Sarfaty
keywords: biosimilar; cancer therapeutics; protein therapeutics; recombinant DNA-derived therapeutic proteins; therapeutic protein drugs