HUMANIZED ANTIBODY HAVING MINIMIZED ADVERSE IMMUNE RESPONSE AND PROCESS FOR PREPARING THE SAME BY GRAFTING SDRS(SPECIFICITY DETERMINING RESIDUES) IN CDRS(COMPLEMENTARY DETERMINING RESIDUES) OF MURINE MONOCLONAL ANTIBODY TO HUMAN ANTIBODY

摘要

PURPOSE: A process for preparing a humanized antibody by grafting SDRs(specificity determining residues) in CDRs(complementary determining residues) of murine monoclonal antibody to human antibody and the humanized antibody prepared therefrom are provided, thereby preparing the humanized antibody having minimized adverse immune response (HAMA response) as well as enhanced affinity to antigen. CONSTITUTION: The process for preparing a humanized antibody comprises the steps of: (a) selecting a specificity determining residue (SDR) of the complementarity determining region (CDR) of murine monoclonal antibody heavy chain and light chain variable regions; and (B) grafting the SDR to at least one of the corresponding amino acid sequences into human antibody variable regions, wherein step (a) is conducted by replacing each the amino acid residues of CDR with alanine to produce transformants, selecting a transformant that has lower affinity to the human antigen (KD) than the original murine antibody and determining the replaced amino acid residue of said transformant as an SDR.