Patent ID: 8725421

Claim:
A method for estimating the in vivo human half-life of a monoclonal antibody of interest comprising: (a) determining an in vitro proteolytic half-life in an in vitro protease reaction assay for each of at least four different reference monoclonal antibodies and for said antibody of interest, wherein said reference antibodies have different known in vivo human half-lives and wherein said in vitro protease reaction assays are performed under identical conditions, (b) determining a correlation between the known in vivo human half-lives and the in vitro proteolytic half-lives of the reference antibodies, (c) estimating from the correlation in (b) between the known in vivo human half-lives and the in vitro proteolytic half-lives of the reference antibodies the in vivo human half-life of the antibody of interest that correlates with the in vitro proteolytic half-life of the antibody of interest.