Immunoglobulin Fc-Fusion Proteins:Part 1: Their Design and Manufacture

摘要

Over the past three decades, 45 monoclonal antibody (MAbs) and MAb-derivative products have been approved fortherapeutic use in the United States (Table 1). One class of antibody derivatives is growing in importance: Fc-fusion proteins.Many biologically active proteins, including receptor ECDs (see "Abbreviations" box), cytokines, enzymes, and bioactive peptides have very short serum half lives because rapid renal clearance limits their exposure in target tissue (and, consequently, their pharmacological effect). The primary reason for fusing a biologically active protein with Fc is half-life extension (l).