期刊
TRENDS IN BIOTECHNOLOGY
卷 33, 期 1, 页码 27-34出版社
ELSEVIER SCIENCE LONDON
DOI: 10.1016/j.tibtech.2014.11.001
关键词
therapeutic proteins; Fe-fusion technology; immunogenicity; neutralizing antidrug antibodies; Fc receptors; drug development
资金
- Laboratory of Hemostasis, Center for Biologics Evaluation and Research
- FDA's Modernization of Science Program
- Critical Path initiative
- FDA Chief Scientist's Challenge Grant
The platform technology of fragment crystallizable (Fc) fusion, in which the Fc region of an antibody is genetically linked to an active protein drug, is among the most successful of a new generation of bioengineering strategies. Immunogenicity is a critical safety concern in the development of any protein therapeutic. While the therapeutic goal of generating Fc-fusion proteins has been to extend half-life, there is a critical mass of literature from immunology indicating that appropriate design of the Fc component has the potential to engage the immune system for product-specific outcomes. In the context of Fc-fusion therapeutics, a review of progress in understanding Fc biology suggests the prospect of engineering products that have an extended half-life and are able to modulate the immune system.
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