摘要:
The present invention relates to a CH3 domain variant pair of an antibody, to a method for preparing same, and to a use thereof, wherein a mutation is induced in the CH3 domain so as to improve a yield of forming a heterodimer heavy chain constant region of an antibody. The CH3 domain heterodimer according to the present invention, forms a heterodimer heavy chain constant region with a high efficiency of 90 to 95% or more and also has outstanding heat stability. A heterodimer heavy chain constant region including the CH3 domain heterodimer can construct a bispecific monoclonal antibody which simultaneously recognizes two kinds of antigens. The CH3 domain heterodimer of the present invention, and the bispecific antibody or fusion protein of an antibody constant region comprising same can be usefully applied to the treatment or prevention of a disease associated with a target antigen or a target protein.
摘要:
The present invention relates to a heterodimeric Fc-fused protein comprising a first Fc region and a second Fc region of an immunoglobulin Fc pair and a physiologically active protein composed of two or more different subunits, wherein one or more subunits of the physiologically active protein are linked separately to one or more ends of the N-terminus or C-terminus of the first Fc region and/or the second Fc region, and CH3 domains of the first Fc region and the second Fc region are mutated so as to promote the heterodimeric Fc formation. Moreover, the present invention relates to a pharmaceutical composition comprising the heterodimeric Fc-fused protein. The heterodimeric Fc-fused protein according to the present invention has an advantage in that it can retain the activity of a naturally occurring physiologically active protein whose two or more different subunits exhibit physiological activity by forming a protein complex, because the physiologically active protein can be linked to an immunoglobulin heterodimeric Fc such that the naturally occurring form and structure of the fused protein thereof can be maintained. When the heterodimeric Fc-fused protein according to the present invention is used, there is an advantage in that the in vivo half-life of the physiologically active protein contained in the heterodimeric Fc-fused protein can be significantly increased due to the Fc-mediated long half-life such that various physiological activities thereof in vivo can be long-lasting.
摘要:
The present invention relates to a CH3 heterodimer comprising a CH3 domain variant pair comprising a first CH3 domain and a second CH3 domain each comprising one mutation or more than one mutation for yielding 90% or more increase in heterodimeric protein formation. A heterodimer heavy chain constant region including the CH3 heterodimer can construct a bispecific monoclonal antibody which simultaneously recognizes two kinds of antigens. The CH3 heterodimer of the present invention, and the bispecific antibody or fusion protein of an antibody constant region comprising same can be usefully applied to the treatment or prevention of a disease associated with a target antigen or a target protein.
摘要:
The present disclosure relates to a method for evaluating and screening a mutant inducing the high-efficiency formation of heterodimers from a human antibody heavy chain constant region mutant pair combination library in order to increase the yield of formation of human antibody heterodimeric heavy chain constant regions, and to a heterodimeric heavy chain constant region (heterodimeric F) library thereby. In addition, the present disclosure relates to a CH3 domain mutant pair in which the formation of the heterodimeric heavy chain constant regions is preferred in the library, to a heterodimeric heavy chain constant region pair comprising the CH3 mutant pair, to a bispecific antibody, to a fusion protein, and a use thereof. The CH3 domain mutant pair according to the present disclosure forms heterodimeric heavy chain constant regions at a high yield of at least 80-90%, and also has excellent thermal stability and retains binding ability to the heavy chain constant region receptor (FcRn). The CH3 domain mutant pair, the bispecific antibody comprising the same, or the antibody constant region fusion protein of the present disclosure can be usefully applied to the treatment or prevention of diseases associated with target antigens or target proteins.