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

F1000Research

Wojciech Jankowski¹  Chava Kimchi-Sarfaty¹  Vijaya L. Simhadri¹  Aikaterini Alexaki¹  H.A. Daniel Lagassé¹  Nobuko H. Katagiri¹  Zuben E. Sauna¹ 

[1] 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;

关键词: Biomacromolecule-Ligand Interactions;    Cancer Therapeutics;    Directed Molecular Evolution;    Drug Discovery & Design;    Immunopharmacology & Hematologic Pharmacology;    Macromolecular Chemistry;    Molecular Pharmacology;    Pharmacokinetics & Drug Delivery;    Protein Chemistry & Proteomics;    Toxicology;   

DOI  :  10.12688/f1000research.9970.1

来源: DOAJ

【 摘 要 】

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).

【 授权许可】

Unknown