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Hurdles and Leaps for Protein Therapeutics

Cytokines and Inflammation

Authors

  • Steven Kozlowski,

    1. Office of Biotechnology Products, Office of Pharmaceutical Science, Center for Drug Evaluation and Research, U.S. FDA, Silver Spring, Maryland, USA
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  • Barry Cherney,

    1. Division of Therapeutic Proteins, Office of Biotechnology Products, Office of Pharmaceutical Science, Center for Drug Evaluation and Research, U.S. FDA, Bethesda, Maryland, USA
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  • Raymond P. Donnelly

    1. Division of Therapeutic Proteins, Office of Biotechnology Products, Office of Pharmaceutical Science, Center for Drug Evaluation and Research, U.S. FDA, Bethesda, Maryland, USA
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Address for correspondence: Dr. Steven Kozlowski, Office of Biotechnology Products, OPS, CDER, Food and Drug Administration, White Oak Building 21 Room 1510, 10903 New Hampshire Ave, Silver Spring, MD 20993. Voice: 301-796-2046; fax: 301-796-9743. steven.kozlowski@fda.hhs.gov

Abstract

Cytokines encompass a wide variety of proteins that can trigger many cellular activities. An important set of cytokines modulate inflammatory responses (inflammatory cytokines). These molecules have potent biological activities and have been a major focus for protein drug development. There have been both successes and failures in this area. Initial hurdles, such as limited manufacturing capacity, have now been largely overcome. However clinical development remains a challenge. On the basis of the history of cytokine therapeutics, a number of strategies for future drug development are considered.

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