SYNAGIS® (PALIVIZUMAB) for Intramuscular Administration

DESCRIPTION: Synagis® (palivizumab) is a humanized monoclonal antibody (IgG1κ ) produced by recombinant DNA technology, directed to an epitope in the A antigenic site of the F protein of respiratory syncytial virus (RSV). Palivizumab is a composite of human (95%) and murine (5%) antibody sequences. The human heavy chain sequence was derived from the constant domains of human IgG1 and the variable framework regions of the VH genes Cor (1) and Cess (2). The human light chain sequence was derived from the constant domain of Cκ and the variable framework regions of the VL gene K104 with Jκ -4 (3). The murine sequences were derived from a murine monoclonal antibody, Mab 1129 (4), in a process which involved the grafting of the murine complementarity determining regions into the human antibody frameworks. Synagis® (palivizumab) is composed of two heavy chains and two light chains and has a molecular weight of approximately 148,000 Daltons.